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Randomized Phase III Trial of MEDI4736 (durvalumab) asConcurrent and Consolidative Therapy or ConsolidativeTherapy Alone for Unresectable Stage 3 NSCLC (EA5181) (PSCI# 21-041).

The purpose of this study is to compare the usual approach of chemo/radiation followed by one year of MEDI4736 (durvalumab) to chemo/radiation with MEDI4736 (durvalumab) followed by one year of MEDI4736 (durvalumab). The addition of MEDI4736 (durvalumab) during chemo/radiation could prevent your cancer from returning and extend your life. But, it could also cause side effects.This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study drug extends the life of patients and/or prevents the tumor from coming back as compared to the usual approach.This drug, MEDI4736 (durvalumab), is already approved by the FDA for use in other cancers, and for use in your type of cancer after the completion of chemotherapy and radiation. At this time MEDI4736 (durvalumab) is not yet approved (experimental) when given with chemotherapy and radiation. There will be about 660 people taking part in this study.

The purpose of this study is to compare the usual approach of chemo/radiation followed by one year of MEDI4736 (durvalumab) to chemo/radiation with MEDI4736 (durvalumab) followed by one year of MEDI4736 (durvalumab). The addition of MEDI4736 (durvalumab) during chemo/radiation could prevent your cancer from returning and extend your life. But, it could also cause side effects.This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study drug extends the life of patients and/or prevents the tumor from coming back as compared to the usual approach.This drug, MEDI4736 (durvalumab), is already approved by the FDA for use in other cancers, and for use in your type of cancer after the completion of chemotherapy and radiation. At this time MEDI4736 (durvalumab) is not yet approved (experimental) when given with chemotherapy and radiation. There will be about 660 people taking part in this study.

Yes
 

Patrick Ma
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04092283
SITE00000978
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Inclusion Criteria:
Patient must be = 18 years old.
Patient must have an ECOG Performance Status of 0 or 1.
Body weight > 30 kg of patients.
Patient must not have unintentional weight loss > 10% within 30 days prior to registration.
Patient must have a baseline ECG obtained within 6 weeks of registration.

Exclusion Criteria:
Patient must not have any active, known or suspected autoimmune disease and neuromuscular paraneoplastic syndromes
Patient must not have a history of active hepatitis B (chronic or acute) or hepatitis C infection.
Patient must not have a known active tuberculosis infection.
Patient must not have any severe infections within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
Patient must not have signs or symptoms of severe infection (sepsis) within 2 weeks prior registration.
Cancer
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KEYSTROKE: A RANDOMIZED PHASE II STUDY OF PEMBROLIZUMAB (KEYTRUDA®) PLUS STEREOTACTIC RE-IRRADIATION VERSUS SBRT ALONE FOR LOCOREGIONALLY RECURRENT OR SECOND PRIMARY HEAD AND NECK CARCINOMA

Study of Pembrolizumab (KEYTRUDA®) Plus non-surgical radiation therapy Versus non-surgical radiation therapy alone for Recurrent or Second Primary Head and Neck Cancer. This study is evaluating the safety of the addition of pembrolizumab to non-surgical radiation therapy.

The purpose of this voluntary research study is to compare any good and bad effects of using the study drug, pembrolizumab, plus radiation therapy to using radiation therapy alone. The addition of the study drug to radiation could shrink your cancer/prevent it from returning but it could also cause side effects.

Yes
 

Mitchell Machtay
igeier@pennstatehealth.psu.edu
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03546582
STUDY00017112
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Inclusion Criteria:
Confirmed diagnosis of recurrent or any new primary squamous cell carcinoma of the head and neck
Patients for whom resection would be medically contraindicated and/or would impose excessive surgical risk
Patients must have had prior radiation to the head and neck

Exclusion Criteria:
Patients with distant metastases
Tumors that involve more than 180 degrees of the carotid artery
Patients with tumor ulceration through the skin
Disease that requires two or more discontiguous target volumes will be ineligible.
Cancer
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A Phase II/III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPCA (PSCI# 20-016) (EA3161)

The purpose of this study is to compare the usual treatment alone (radiation and chemotherapy) to adding maintenance nivolumab to the usual treatment. The addition of nivolumab to the usual treatment could shrink your cancer or prevent it from returning. But, it could also cause side effects, which are described in the risks section below.This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the nivolumab increases the lifetime of the patient without progression for 10 years.This immunotherapy drug, nivolumab, is already approved by the FDA for use in advanced and incurable head and neck cancer. But, most of the time it is not used until the cancer is very advanced and chemotherapy stops working. In this study we believe the use of nivolumab has a chance of preventing the cancer from coming back for patients with your type of cancer. There will be about 286 people taking part in the first part (phase II) of the study and 458 more people taking part in second part (phase III), if the results of the phase II portion are promising and if there is evidence that nivolumab may prolong your life.

The purpose of this study is to compare the usual treatment alone (radiation and chemotherapy) to adding maintenance nivolumab to the usual treatment.

Yes
 

Mitchell Machtay
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03811015
SITE00000750
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Inclusion Criteria:
Age ≥ 18 years.
ECOG performance status of 0 or 1.
Patients must have oropharynx cancer that is p16-positive by immunohistochemistry
Adequate baseline organ and marrow function
Adequate baseline liver functionality

Exclusion Criteria:
Patients with a history of allergic reactions attributed to platinum based chemotherapy agents
Patients must not have had prior systemic therapy or radiation treatment for p16 positive OPSCC
Patients must not have received previous irradiation for head and neck, tumor, skull base, or brain tumors
Patients must not have known hypersensitivity to nivolumab
Patients with evidence of distant metastases or leptomeningeal disease are excluded
Cancer
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Hershey, PA ,

An Open Label, Randomized, Multicenter, Phase Ib/II Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination with Polatuzumab Vedotin in patients with B-Cell Non-Hodgkin Lymphoma(GO40516)(PSCI18-058)

This is a drug study that will compare drug mosunetuzumab with drug polatuzumab vedotin in patients with non-Hodgkin lymphoma (NHL).

This study has three parts:1. Screening (to see if you are eligible for the study)2. Treatment3. Follow-up (to check on you after treatment is finished)If you are enrolled in the FL or DLBCL cohort during the single-arm expansion phase, you will receive mosunetuzumab for 8-17 cycles and polatuzumab vedotin for 6 cycles, with each cycle lasting 21 days.In addition to the single-arm expansion phase, the study may open another expansion phase of the study for the DLBCL cohort. If you are enrolled in the additional DLBCL expansion phase, you will be randomly assigned to one of three possible arms. Neither you nor your study doctor may choosethe arm you will be in.- Mosunetuzumab in combination with polatuzumab vedotin- Mosunetuzumab alone- Bendamustine plus rituximab in combination with polatuzumab vedotinAfter your last dose, your study doctor will follow up with you about every 3 months for approximately2 years or longer (as long as you agree to it). Your total time in the study (Phase II expansion portion)will depend on how your DLBCL, FL, or MCL responds to treatment. This could range from 1 dayto more than 2 1/2 years.

Yes
 

Seema Naik
PSCI-CTO@pennstateheatlh.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03671018
STUDY00013902
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Inclusion Criteria:
Must have received at least one prior systemic treatment regimen containing an anti-CD20 directed therapy for DLBCL or FL.
Life expectancy of at least 12 weeks 

Measurable disease, defined as at least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension
Adverse events from prior anti-cancer therapy resolved to < or = Grade 1
Hepatic Function: < or =AST and ALT < or = 2.5 x ULN; total bilirubin < or = 1.5 x ULN

Exclusion Criteria:
Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months
Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies
Prior treatment with polatuzumab vedotin
Prior use of any monoclonal antibody, radioimmunoconjugate or ADC within 4 weeks before first dose of study treatment
Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment
Cancer
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Hershey, PA ,

20-081, Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Combo with Axitinib in Advanced RCC

Determine the maximum tolerated dose or maximum administered dose of MEDI5752 combined with axitinibAssess the safety and tolerability of MEDI5752 combined with axitinibAssess the antitumor activity of MEDI5752 combined with axitinib

The study will consist of 3 periods: screening, study treatment, and follow-up. You are expected to keep all of your study appointments and complete all study procedures.

$75 Per visit

Yes
 

Monika Joshi
PSCI-CTO@pennstatehealth@psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04522323
SITE00000858
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Inclusion Criteria:
Body weight > 35 kg
Histologically or cytologically proven advanced RCC
Advanced RCC not previously treated in that setting
Must have at least 1 measurable lesion according to RECIST v1.1
Life expectancy ≥ 12 weeks

Exclusion Criteria:
Previous treatment with axitinib
Previous treatment with mTOR inhibitors, PD-1, PD-L1, or CTLA-4 inhibitors for RCC
History of active primary immunodeficiency
History of organ transplant
Cancer
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Hershey, PA ,

PSCI 21-176 Gilead ENHANCE 3 (GS-US-590-6154)

The purpose of this study is to see if magrolimab in combination with venetoclax and azacitidine is more effective than venetoclax and azacitidine in participants newly diagnosed with AML that are unfit for intensive chemotherapy.

Participants will be required to provide medical history, complete physical exam, laboratory tests, bone marrow biopsy and aspirate, ECOG, ECG, Echo or MUGA, pulmonary function tests, questionnaires, take study drug

Yes
 

Shin Mineishi
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05079230
SITE00001311
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Inclusion Criteria:
Previously untreated patients with histological confirmation of AML by WHO criteria who are ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age, or comorbidity.
ECOG performance status: a) Of 0 to 2 for subjects ≥ 75 years of age Or b) Of 0 to 3 for subjects ≥ 18 to 74 years of age
Patients with white blood cell (WBC) count ≤ 20  103/μL prior to randomization.
Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment.
Patient has provided informed consent

Exclusion Criteria:
Positive serum pregnancy test
Breastfeeding female
Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
Patients receiving any live virus vaccine within 4 weeks prior to initiation of study treatments
Prior treatment with any of the following: a) CD47 or SIRPα-targeting agents
Cancer
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Phase III IGRT and SBRT VS IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer (NRG-GU005) (PSCI# 19-073)

The purpose of this study is to compare any good and bad effects of using stereotactic body radiation therapy (SBRT), a technique that gives treatment in a shorter amount of time compared to the usual radiation therapy. SBRT is experimental for treating this type of cancer. SBRT uses special equipment to position a participant and precisely deliver radiation to tumors in the body. Both the study and the usual radiation treatments use daily images to guide the radiation treatment to protect normal tissue. The study treatment, treatment over a shorter amount of time, may prevent the tumor from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach using SBRT is better, the same, or worse than the usual approach. To be better, the study treatment should increase the time without the cancer coming back by six months or more compared to the usual approach, and show improvements in side effects to the bladder or rectum.

The purpose of this study is to compare any good and bad effects of using stereotactic body radiation therapy (SBRT), a technique that gives treatment in a shorter amount of time compared to the usual radiation therapy. SBRT is experimental for treating this type of cancer. SBRT uses special equipment to position a participant and precisely deliver radiation to tumors in the body. Both the study and the usual radiation treatments use daily images to guide the radiation treatment to protect normal tissue. The study treatment, treatment over a shorter amount of time, may prevent the tumor from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach using SBRT is better, the same, or worse than the usual approach. To be better, the study treatment should increase the time without the cancer coming back by six months or more compared to the usual approach, and show improvements in side effects to the bladder or rectum.

Yes
 

Joseph Miccio
Kathleen Rizzo - at krizzo@pennstatehealth.psu.edu or 717-531-0003, ext=289630
Radiation Oncology (HERSHEY)
 

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03367702
SITE00000651
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Inclusion Criteria:
ECOG Performance Status 0-1 60 days prior to registration
Previously untreated localized adenocarcinoma of the prostate
Clinical stage by digital rectal exam of either T1c or T2a/b
The prostate volume must be < 60 cc as reported at time of biopsy or by separate measure with ultrasound or other imagining modalities including MRI or CT scan
Age is 18 years or older

Exclusion Criteria:
Definitive clinical or radiologic evidence of metastatic disease. No nodal involvement or evidence of metastatic disease allowed as defined by screening of the pelvis
Definitive T3 disease on MRI
Prior or current invasive malignancy with current evidence of active disease within the past 3 years
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; must be off treatment
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Cancer
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Hershey, PA ,

CRESTONE: A Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors (ELVCAP-001-01)(20-095)

Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors

Most of the examinations, tests and procedures are part of the usual approach for your cancer. However, there will be extra procedures like blood draws and additional tests on your tumor to determine if your condition is suitable to take part in this study.There are three stages to this study: Screening, Study Treatment period, End of Study Treatment/Follow-up.

Yes
 

Patrick Ma
Irina Geier - at igeier@pennstatehealth.psu.edu
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04383210
SITE00000889
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Inclusion Criteria:
Locally-advanced or metastatic solid tumor with an NRG1 gene fusion
Availability of fresh or archived tumor sample
Minimum of one prior standard therapy appropriate for their tumor type and stage of disease, progressed or been nonresponsive to these available therapies
ECOG performance status 0, 1 or 2
At least one measurable extra-cranial lesion

Exclusion Criteria:
Non - NRG-1 mutations
Life expectancy < 3 months
Pregnant or lactating
Symptomatic or untreated brain metastases
Known hypersensitivity to any of the components of seribantumab
Cancer
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Hershey, PA ,

22-124 Main-CAV

To evaluate the effect of cabozantinib in combination with avelumab on OS compared to avelumab alone in patients with mUC who did not progress during first-line platinum-based chemotherapy therapy, i.e. patients who had CR, PR or SD after completion of first line platinum-based chemotherapy.

Patients will be expected to come to all clinic appointments, have labs drawn on the first day of every cycle, take medications as prescribed, return all empty pill bottles and diary, and call the clinic with questions.

Yes
 

Monika Joshi
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05092958
SITE00001285
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Inclusion Criteria:
Histologically or cytologically-confirmed diagnosis of advanced or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra
Prior first-line treatment must have consisted of 4-6 cycles of 1st-line therapy (platinum-based chemotherapy; gemcitabine-cisplatin, gemcitabine-carboplatin, MVAC or ddMVAC).
No prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PDL2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
ECOG Performance Status of 0 or 1
Age ≥ 18 years

Exclusion Criteria:
Active autoimmune disease that might deteriorate when receiving the anti PD-L1 agent, avelumab.
No known symptomatic central nervous system (CNS) metastases.
No major surgery within 4 weeks prior to randomization.
No palliative radiotherapy within 48 hours prior to patient randomization.
No known cavitating pulmonary lesion(s) or known endobronchial disease manifestation.
Kidney & Urinary System, Cancer
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Harrisburg, PA ,
Hershey, PA ,

A Phase II/III Trial of De-intensified Radiation Therapy for Patients with Early-Stage, P16 Positive Oropharyngeal Cancer (NRG-HN005) (PSCI# 20-011)

The purpose of the first part of this study is to compare the usual treatment of a standard-dose radiation given over 6 weeks with cisplatin chemotherapy to a reduced-dose radiation given over either 6 weeks with cisplatin or 5 weeks with the immunotherapy drug, nivolumab. A lower dose of radiation as compared to the usual radiation treatment dose could be as effective in lengthening the time without your cancer getting worse. Nivolumab with reduced-dose radiation may or may not be as effective in lengthening the time without your cancer getting worse. This study will help the study doctors find out if this different approach is the same or worse than the usual approach.

The purpose of the first part of this study is to compare the usual treatment of a standard-dose radiation given over 6 weeks with cisplatin chemotherapy to a reduced-dose radiation given over either 6 weeks with cisplatin or 5 weeks with the immunotherapy drug, nivolumab. A lower dose of radiation as compared to the usual radiation treatment dose could be as effective in lengthening the time without your cancer getting worse. Nivolumab with reduced-dose radiation may or may not be as effective in lengthening the time without your cancer getting worse.This study will help the study doctors find out if this different approach is the same or worse than the usual approach.

Yes
 

Mitchell Machtay
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03952585
SITE00000721
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Inclusion Criteria:
Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx
Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations
P16-positive based on local site immunohistochemical tissue staining
Zubrod Performance Status of 0-1 within 14 days prior to registration
Only English, Spanish, or French speaking patients are eligible to participate as these are the only languages for which the mandatory dysphagia-related patient reported instrument (MDADI) is available

Exclusion Criteria:
Clinical stages T0; T4; T1-2, N0; or any N2 (AJCC, 8th ed)
Recurrent disease
Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
Cancers considered to be from an oral cavity site or the nasopharynx, hypopharynx, or larynx, even if p16-positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas
Carcinoma of the neck of unknown primary site origin (T0 is ineligible, even if p16-positive)
Cancer
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Hershey, PA ,
Reading, PA ,

Return to Work Survey Development for Breast Cancer Survivors

The purpose of this study is to develop and test a survey to gain information that will improve our understanding of the return to work experience for breast cancer survivors. Study participants will answer questions on a questionnaire and undergo a one-on-one interview about those questions to ensure the wording and content is appropriate.

This is a questionnaire development study. Participants will be asked to complete a series of questions on a questionnaire form. Next, participants will sit for a one-on-one interview to discuss the questions and answer choices on the questionnaire.

Yes
 

Meghan Vidt
Jared Heitzenrater - at jheitzenrater@pennstatehealth.psu.edu or 717-531-0003, ext=323324
Biomedical Engineering (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00019881
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Inclusion Criteria:
Previous diagnosis of breast cancer, stage 0-III
Last cancer treatment was 2-5 years ago
Received breast cancer treatment at Penn State Health
Employed outside the home at least part time (>20hr/wk) before and after cancer treatment

Exclusion Criteria:
Last cancer treatment was less than 2 years or greater than 5 years ago
Underwent prophylactic treatment due to increased risk, such as testing positive for BRCA gene (breast cancer)
Unemployed or does not participate in the workforce for pay either before or after cancer
Currently being treated for any type of cancer
Has experienced a work-related injury that does not allow work, is receiving Worker's Compensation, or is currently in litigation for work-related injury
Cancer
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Hershey, PA ,

A Phase 1/2, Open-label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects with Advanced or Metastatic Malignancies Harboring ALK, ROS1, or NTRK1-3 Alterations (CARE)

Repotrectinib for cancer that has returned or is not responding to treatment

If you agree to take part in this study, you will need to visit the study site regularly and follow the study procedures listed later in this document. You will be told what these procedures are and why they are needed. These procedures include interviews, exams, heart testing, tumor assessments, and blood and urine samples. You will be asked to take the study drug Repotrectinib. This is a capsule to be taken orally.

Yes
 

Valerie Brown
Suzanne Treadway - at streadway@pennstatehelath.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT04094610
STUDY00014715
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Inclusion Criteria:
You have cancer that has returned or is not respondin g to treatment
You are positive for certain changes in your genes which we will test you for as needed

Exclusion Criteria:
1. You have gastrointestinal disease, such as Crohn’s disease,
Cancer
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Hershey, PA ,

Phase 1/2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

This Phase 1 and 2 study is to determine the safety of APL-101 in subjects with NSCLC with specific mutations. It is also to determine the dose that is tolerable for oral administration of APL-101. And to see if there is a clinical benefit to subjects for the amount of time to progression, or progression free survival and overall survival.

We are asking you to give permission for your doctor to send your stored tumor tissue sample for cancer genetic analysis. As part of your cancer care, your doctor may have already collected a tumor tissue biopsy sample (of your cancer tissue) in the past, recently, or being planned as part of standard medical care. Your doctor will ask for any of your stored or available tumor tissue sample collected elsewhere from previous doctors you may have seen in the past. We will not ask you to undergo a new tissue biopsy procedure for this testing however your treating physician may decide to do so as part of your standard of care.There is no required visit for this testing. Once you have signed this consent, your available tumor tissue sample from a prior biopsy or surgery along with the pathology report will be sent to an accredited and certified external genetic laboratory (such as Caris Life Sciences or Interpace Pharma Solutions) to test and understand your cancer’s genetic make-up. The use of your tumor tissue samples as described in this form is necessary for the genetic testing. Without your consent to test your samples, the genetic testing cannot be performed. Once you agree to provide your samples, they cannot be returned to your doctor’s clinic. If the genetic testing of your samples show you have c-MET genetic dysregulations in your cancer, your doctor will discuss your treatment options including clinical trials, such as the APL-101-01 SPARTA trial, with you. If you are interested in participating, you will be asked to review and sign another participant information and informed consent form for the clinical trial before undergoing further screening tests to confirm if you are eligible to participate. The genetic results could also be used to help your clinic doctor decide on an approved therapy, or other investigational therapies that may be right for your specific cancer genetic alterations.

Yes
 

Patrick Ma
Irina Geier - at igeier@pennstatehealth.psu.edu or 717-531-8678
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03175224
STUDY00014799
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Inclusion Criteria:
Phase 1, histologically and / or cytological confirmed unresectable or metastatic solid malignancy, refractory to standard therapies with no more than three prior lines of therapy
Women of child-bearing potential (WOCBP) must have a negative serum or β-human chorionic gonadotropin (β-hCG) at screening or evidence of surgical sterility or evidence of postmenopausal status.
Abnormal c-Met dysregulation, by tissue and/or plasma, defined as the following from local/archival molecular pre-screening evaluations.
Measurable disease according to RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0–1

Exclusion Criteria:
Hypersensitivity to APL-101, excipients of the drug product, or other components of the study treatment regimen.
Known mutation/gene rearrangement of EGFR (except for Cohort C), ALK, ROS1, RET, NTRK, KRAS, and BRAF.
Active uncontrolled systemic bacterial, viral, or fungal infection or clinically significant, active disease process
History of, or currently, or at risk for, cardiac disease (e.g., long QT syndrome [> 450 msec QTcF or concurrent treatment with any medication that prolongs QT interval).
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., Crohn’s, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption sydrome).
Cancer
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Hershey, PA ,

PSCI# 18-127 EA6174 Adjuvant MK-3475 to SOC

The purpose of this Phase III study is to compare Overall Survival (OS) and Recurrence Free Survival (RFS) across the two arms: MK3475 (Pembrolizumab) to Standard of Care Observation. Patients will undergo standard clinical procedures including physical, labs, vitals, ecg's, and imaging.

We are asking you to take part in a research study. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.

Yes
 

Joseph Drabick
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03712605
SITE00000461
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Inclusion Criteria:
Patients must have an ECOG performance Status: 0, 1, or 2
Patient must have a histological confirmation of diagnosis of Merkel cell carcinoma (MCC), pathologic stages (AJCC version 8) I-IIIb.
completely resected by surgery within 8 weeks before enrollment.
All patients must have disease-free status documented by a complete physical examination and conventional imaging studies within 4 weeks prior to randomization.
Patients must not be on active immunosuppression, have a history of life threating virus, have had other cancer diagnoses in the last two years

Exclusion Criteria:
Women who are pregnant
present metastases
previous systemic therapy or radiation therapy for Merkel cell carcinoma.
inoperable disease who have received radiation are not eligible.
history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Cancer
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PSCI-22-042: M23-362 Epcoritamab monotherapy R/R DLBCL or Classic FL (Previously Grade 1-3a) outpatient

The purpose of this voluntary research study is to optimize the approach to safely administer a study drug called epcoritamab in the outpatient/non-hospital setting.

Complete interview, questionnaires, and subject diaryECGClinical laboratory testsBiopsy sample, archival or freshCT/PET-CT/MRITreatment of epcoritamab

Yes
 

Seema Naik
Laurie ONeal - at loneal1@pennstatehealth.psu.edu or 717-531-0003, ext=343429
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05451810
SITE00001234
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Inclusion Criteria:
Subjects must voluntarily sign and date an informed consent,
Adult male or female, at least 18 years old
Diagnosis of R/R DLBCL or R/R FL grade 1, 2, or 3a, with documented CD20+ mature B-cell neoplasm according to WHO classification 2016 or WHO classification 2008 based on representative pathology report
Subject must have 1 or more measurable disease sites:  Fluorodeoxyglucose (FDG)-avid lymphomas:
Subject must have Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2

Exclusion Criteria:
Central nervous system (CNS) involvement
inadequate organ functions
central nervous system involvement
history of primary mediastinal lymphoma.
history of severe allergic or anaphylactic reactions to anti-CD20 monoclonal antibody therapy.
Cancer
Not applicable
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Hershey, PA ,

A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) plus Palbociclib versus Anastrozole plus Palbociclib for the Treatment of Patients with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

The purpose of this voluntary research study is to learn more about treatment with an experimental drug called AZD9833 in combination with palbociclib. Participants will be required to follow your study doctor’s instructions, come to the study visits, take the study medications, and have the tests and examinations.

Participants will be required to: attend in person visitsreceive study treatmentradiology assessmentsblood testscomplete questionnaireshave an eye examhave a tumour biopsy

Yes
 

Monali Vasekar
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04987203
SITE00001345
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Inclusion Criteria:
Capable of giving signed informed consent as described in Appendix A 3, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Evidence of a personally signed and dated informed consent document indicating that the patient (or legal representative) has been informed of all pertinent aspects of the study before any study-specific activity is performed.
Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of sample for optional genetic research that supports Genomic Initiative (as allowed per local regulations).
Female or male, ≥ 18 years at the time of screening.
Histologically or cytologically documented diagnosis of ER+, HER2-negative breast cancer based on local laboratory results and who are not amenable to resection or radiation therapy with curative intent.

Exclusion Criteria:
Have advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal]) and pulmonary lymphangitis).
Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral oedema, and/or progressive growth.
History of another primary malignancy except for the following: • Malignancy treated with curative intent with no known active disease ≥ 3 years before the first dose of study treatment, and of very low potential risk for recurrence.
As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including renal transplant and active bleeding diseases)
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings,
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Dysgeusia and Anosmia in Head and Neck Cancer Patients: Long Term Outcomes

The primary aim of this study is to understand taste changes after head and neck cancer treatment, especially long term taste disturbance, using various methods including online surveys, Teams interviews, at home taste and smell tests, and MRIs.

The purpose of this voluntary research study is to identify taste changes in patients treated for head and neck cancer. We are recruiting healthy participants over the age of 40 as well as head and neck cancer survivors who were treated 4 or more years ago. The overall study consists of multiple parts, which are explained along the way. You can choose to participate in this portion, which is an online survey, and nothing else, or all of the invited components. •The survey will take approximately 10 minutes of your time. •Completion of this survey is voluntary and you are not required to complete it if you do not wish to do so.•At the end of the survey you will be asked about your willingness to participate in other portions of this study. These include at-home taste and smell tests over Teams and a Teams interview about your taste and smell function. Participating in these tasks is optional and not required. If you complete the smell and taste tests at home you may be invited to have an MRI scan.

Max of $75: No compensation for the survey, $15 giftcard for 1-hour interview (optional), $15 giftcard for at-home taste/smell tests (optional), $50 giftcard for MRI at Hershey Med Center (optional).

No
 

Neerav Goyal
Hanel Eberly - at HNCtaste@pennstatehealth.psu.edu
Otolaryngology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019457
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Inclusion Criteria:
Able to give consent
Over the age of 40
English Speaking

Exclusion Criteria:
Under 40 years of age
have undergone a total glossectomy
currently have an upper respiratory infection, sinus infection, or ear infection
Cancer
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A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)

This is a study that will compare a study drug pembrolizumab plus a study drug lenvatinib in combination with the therapy called TACE (transarterial chemoembolization) which is a way to deliver chemotherapy locally through a procedure called embolization and how that works versus placebo (or no study medications) plus TACE and how it could lead to progression-free survival (PFS).

This is a study that will compare a study drug pembrolizumab plus a study drug lenvatinib in combination with the therapy called TACE (transarterial chemoembolization) which is a way to deliver chemotherapy locally through a procedure called embolization and how that works versus placebo (or no study medications) plus TACE and how it could lead to progression-free survival (PFS).

Yes
 

Nelson Yee
Irina Geier - at igeier@pennstatehealth.psu.edu or 717-531-8678
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04246177
STUDY00014964
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Inclusion Criteria:
Has a diagnosis of HCC confirmed by radiology, histology, or cytology
Has HCC localized to the liver without portal vein thrombosis, and not amenable to curative treatment such as resection, ablation, or liver transplant.
Has at least one measurable HCC lesion based on RECIST 1.1,
Has an ECOG performance score of 0 to 1
Has a predicted life expectancy of >3 months.

Exclusion Criteria:
Is currently a candidate for liver transplantation.
Has had esophageal or gastric variceal bleeding within the last 6 months.
Has clinically apparent ascites on physical examination that is not controlled with medication
Has had clinically diagnosed hepatic encephalopathy in the last 6 months unresponsive to therapy.
Has clinically significant hemoptysis from any source or tumor bleeding within 2 weeks prior
Cancer
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Hershey, PA ,

NRG-GI008 Colon Adjuvant Chemotherapy based on Evaluation of Residual Disease (CIRCULATE-US) (22-070)

To compare time to ctDNA (+ve) status in ctDNA (-ve) cohort following resection of stage III colon cancer treated with immediate vs delayed (based on serial ctDNA surveillance) chemotherapy. Time to positive event is defined as time from randomization to the first ctDNA positive result for the immediate arm (Arm 1) and to the 2nd ctDNA positive result for the delayed arm (Arm 2) to allow for the potential effect of delayed adjuvant chemotherapy. Patients recurred without a positive ctDNA result will be considered to have ctDNA positive status at the time of recurrence for both study arms.

We are asking you to take part in this research study because you have colon cancer that has been treated with surgery but has spread to some of your lymph nodes and is known as stage III colon cancer. Or, you have stage II or stage III colon cancer with a higher risk of cancer returning, your colon cancer has been treated with surgery, and you had ctDNA testing done and are ctDNA positive. Stage II colon cancer is an early stage colon cancer that has been treated with surgery but has not spread to your lymph nodes. ctDNA, or circulating tumor DNA, is DNA that has been released from tumor cells into your bloodstream. This DNA can be measured using a blood test.

Yes
 

Nelson Yee
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05174169
SITE00001215
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Inclusion Criteria:
patient must be ≥ 18 years old.
Hemoglobin must be ≥ 9 g/dL
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
The treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan)
The patient must have an ECOG performance status of 0 or 1

Exclusion Criteria:
Colon cancer histology other than adenocarcinoma
Tumor-related bowel perforation
Synchronous primary rectal and/ or colon cancers
Active seizure disorder uncontrolled by medication
Active or chronic infection requiring systemic therapy
Cancer
Not applicable
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Hershey, PA ,

An Open-Label, Multicenter, Phase I/II Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors

This study is to determine the maximum tolerated dose (MTD) as determined by how often dose limiting toxicities (DLT) happen and/or the recommended Phase 2 dose of the study drug RP1.

A 28-day Screening periodA Study Treatment period which will last up to 2 years. A Follow-Up period – 30 days after last RP1 injection and then 60 days after last RP1 treatment and then also 100 days after the last nivolumab treatment Long Term follow-up period – If you need to stop either the RP1 injections or nivolumab infusions, you will be asked to return at least every 12 weeks for a period of 2 years. You will also be asked about any other anti-cancer therapy you may be taking, every 3 months, for a period of 3 years, from the start of the RP1 injections.

, travel and lodging services may be provided

Yes
 

Joseph Drabick
Irina Geier - at igeier@pennstatehealth.psu.edu or 717-531-8678
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03767348
SITE00000775
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Inclusion Criteria:
Male or female ≥ 18 years of age on the day of signed informed consent
At least 1 measurable (including use of image-guided injection) tumor of ≥ 1 cm in longest diameter (or shortest diameter ≥ 1.5 cm for lymph nodes) and injectable lesions which in aggregate comprise ≥ 1 cm in longest diameter
Adequate hematologic function, adequate hepatic function, adequate renal function
Prothrombin time (PT) ≤ 1.5 × ULN (or international normalization ratio [INR] ≤ 1.3) and partial thromboplastin time (PTT) or activated PTT (aPTT) ≤ 1.5 × ULN
ECOG performance status 0-1

Exclusion Criteria:
Prior treatment with an oncolytic therapy
Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) or HIV infection.
Had systemic infection requiring IV antibiotics or other serious infection within 14 days prior to dosing
Requires intermittent or chronic use of systemic (oral or IV) anti-virals with known anti-herpetic activity (e.g., acyclovir)
With a condition requiring systemic treatment with either corticosteroids (> 20 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study treatment.
Cancer
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A Randomized Phase II Trial of Adjuvant Pembrolizumab versus Observation Following Curative Resectionfor Stage I Non-small Cell Lung Cancer (NSCLC) with Primary Tumors Between 1-4 cm:Big Ten Cancer Research Consortium BTCRC-LUN18-153 (PSCI# 20-043)

This is a research study to find out if giving a drug called pembrolizumab after lung cancer surgery does a better job at keeping the cancer from coming back than surgery alone. The usual approach for patients who are not in a study is to be followed closely by their doctor to watch in case the cancer returns. Participants in this study will be assigned by chance (flip of a coin) to be watched closely by their doctor or to receive a drug called pembrolizumab. Pembrolizumab is given as an infusion inthe clinic once every six weeks. . You will have tests, exams and procedures that are part of your regular care and for study purposes. You will have scans every 12 weeks to make sure the cancer hasn’t come back. If you are assigned to receive pembrolizumab, you can continue to receive it for up to 1 year.

If you decide to take part in this study, you will be assigned to one of two groups. This is called randomization. A computer will assign you to a group in the study by chance. This is done by chance because no one knows if one study group is better or worse than the other. You will have an equal chance (50/50) of being assigned to either group.

Yes
 

Patrick Ma
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04317534
STUDY00015618
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Inclusion Criteria:
Males and females age ≥ 18 years.
Patients must have undergone complete surgical resection of their stage I non-small cell lung cancer between 4-12 weeks prior to registration.
Pathological tumor size must be 1.0 – 4.0 cm in size.
ECOG Performance Score 0-1
Baseline CT chest must be performed within 28 days of randomization

Exclusion Criteria:
Patients with tumors that are known to harbor actionable EGFR mutations are NOT eligible.
No prior PD-1 or PD-L1 inhibitors are permitted.
No prior neo-adjuvant or adjuvant chemotherapy is permitted for this lung cancer.
Patients with a history of (non-infectious) pneumonitis that required steroids
Has active autoimmune disease that has required systemic treatment in the past 2 years.
Cancer
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Hershey, PA ,

Phase 1/2 Study to Evaluate Palbociclib (IBRANCE®) in Combination with Irinotecan and Temozolomide or in Combination with Topotecan and Cyclophosphamide in Pediatric Patients with Recurrent or Refractory Solid Tumors

A study of the safety of palbociclib with irinotecan and temozolomide and palbociclib with topotecan and cyclophosphamide for children with solid tumors that returned or did not respond to previous treatment.

If you join the study, you will be assigned to receive either palbociclib in combination with backbone chemotherapy of IRN and TMZ or the backbone chemotherapy (IRN and TMZ). You may be asked to provide biological samples (such as blood or urine or tumor tissue sample) and undergo procedures that might be different from a regular medical examination. This study will involve screening, treatment, and follow up period. During screening, the study doctor will determine whether you are eligible for the study. If you are eligible and are enrolled into the study, you will be required to visit the study doctor on days 1 to 5 of each 21-day cycle and on day 14 for the first 2 cycles to undergo study assessments and to provide information about your health.

Yes
 

Valerie Brown
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT03709680
STUDY00012769
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Inclusion Criteria:
Have a solid tumor that has returned or did not respond to previous treatment
Ages ≥2 and <21

Exclusion Criteria:
Prior intolerability to the chemo drugs used in this study
Cancer
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Hershey, PA ,

PEDS-PLAN – Pediatric Precision Laboratory Advanced Neuroblastoma Therapy

A study of the safety and feasibility of using molecularly guided therapy in combination with standard therapy followed by maintenance therapy with DFMO in patients with newly diagnosed high risk neuroblastoma.

Participating in this study requires that you visit the study hospital Penn State Hershey Medical Center multiple times over the course of the full study for evaluations (physical exam, blood draw, urine analysis, etc.) and scans (MRI/CT, MIBG). Weekly visits may occur at your home institution with your home treating oncologist. As a subject in this clinical trial you are expected to receive treatment on this phase of the study for a total of about 2 ½ years if you complete all portions. After treatment, you will have follow-up examinations and medical tests.

Yes
 

Valerie Brown
Suzanne Treadway, MS, RN, CCRP - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT02559778
STUDY00003478
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Inclusion Criteria:
A confirmed diagnosis of neuroblastoma.
Must be 21 years of age or younger when diagnosed.
No prior systemic therapy with some exceptions.
Tumor samples will be obtained only in a non-significant risk manner and not solely for the purpose of the study.

Exclusion Criteria:
Receiving another study drug while on this study.
Female patients who are lactating are not eligible unless they agree not toe breast feed.
Children's Health, Cancer
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Hershey, PA ,

Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

This is a study of the drug DFMO (difluoromethylornithine) for neuroblastoma that has returned or not responded to treatment. DFMO is an oral drug that inhibits a certain enzyme (protein) in blood which is associated with a bad outcome in neuroblastoma cases. Cancer cells have pathways that drive the cancer to grow and DFMO targets the specific pathway of this enzyme to turn these cells off.

You will have exams, tests, and procedures while on the study to evaluate whether you can participate in the study and how you are doing while on the study. These include physical exams, blood tests, urine tests, bone marrow aspirate and biopsies, heart tests, hearing tests, and imaging evaluations such as CT scans and MIBG or PET scans. You will receive treatment on this study for a total of about 2 years. After treatment, you will have follow-up examinations and medical tests. We would like to continue to find out about your health for about 5 years after you complete the study.

Yes
 

Valerie Brown
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT04301843
STUDY00015051
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Inclusion Criteria:
Up to 31 years old with history of relapsed/refractory neuroblastoma.
Completed upfront therapy with at least 4 cycles of aggressive multi-drug chemotherapy

Exclusion Criteria:
Received a dose of DFMO in combination with etoposide
Currently receiving another investigational drug
Cancer
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Hershey, PA ,

AYA-UNITE (Utilizing Novel Information Technology to Promote Exercise and Well-Being) in Adolescents and Young Adults with Cancer

Adolescents and young adults (AYAs) with cancer have many needs for supportive care that differ from younger and older patients. This includes age-appropriate psychological support for management of distress, as well as supports for the social isolation many AYAs experience. One exciting intervention that may provide AYAs with cancer improved psychosocial support, as well as increased physical strength, is physical activity. This feasibility project aims to evaluate the safety, feasibility and acceptability of a physical activity training in AYAs with cancer delivered via a socially interactive videoconferencing platform.

No
 

Pooja Rao
Pooja Rao - at prao2@pennstatehealth.psu.edu or 717-531-6012
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT03778658
STUDY00010118
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Inclusion Criteria:
Participant age 15-29 years old at time of cancer diagnosis

Participant diagnosis of cancer who is currently undergoing active treatment for cancer, or who is within 3 years of end of cancer treatment at the time of enrollment
Participant must have access to a computer or smartphone

Exclusion Criteria:
Cardiovascular or respiratory disease

Absolute contraindication to exercise
Pregnant women
Patients with relapsed cancer
atients who have undergone allogeneic stem cell transplant
Sports Medicine, Mental & Behavioral Health, Cancer
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STEEL: A Randomized Phase II Trial of Salvage Radiotherapy with Standard vs Enhanced Androgen Deprivation Therapy (with Enzalutamide) in Patients with Post-Prostatectomy PSA Recurrences with Aggressive Disease Features

Radiation treatment and hormonal therapy vs. Radiation treatment, hormonal therapy plus Enzalutamide in post-prostatectomy cancer recurrences.

Radiation treatment and hormonal therapy vs. Radiation treatment, hormonal therapy plus Enzalutamide in post-prostatectomy cancer recurrences

Yes
 

Joseph Miccio
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Radiation Oncology (HERSHEY)
 

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03809000
STUDY00016786
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Inclusion Criteria:
Prostatectomy performed within 10 years prior to registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted.
PSA level (≥0.2 ng/mL) within 90 days prior to registration.
Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to registration.
At least 1 of the following features: • Gleason score of 8-10 • Seminal vesicle invasion • Locoregional node involvement at radical prostatectomy • Persistently elevated PSA post-RP nadir

Exclusion Criteria:
Definitive clinical or radiologic evidence of metastatic disease with the exception of locoregional lymph nodes
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Cancer
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Hershey, PA ,

22-061 Relugolix Versus Leuprolide in Patients with Prostate Cancer: A Randomized, Open-Label Study to Assess Major AdverseCardiovascular Events (REPLACE-CV)

The purpose of this research study is to compare and see if medications used in ADT treatment, either relugolix or leuprolide acetate, lower the risk of cardiovascular events in patients with prostate cancer. You (or your caregiver) will be asked to complete questionnaires electronically (such as computer, tablet, or smartphone) and/or share information via phone calls every three months until the end of your participation in the study. You will receive the study medications for treatment (either relugolix or leuprolide acetate)

Participants will be required to complete questionnaires electronically (such as computer, tablet, or smartphone) and/or share information via phone calls every three months until the end of your participation in the study. You will receive the study medications for treatment (either relugolix or leuprolide acetate)

$150 per year

Yes
 

Megan Wheelden
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05605964
SITE00001315
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Inclusion Criteria:
Has voluntarily signed and dated the informed consent form prior to baseline visit;
Is a male and 18 years of age or older on the day of signing and dating the informed consent form;
Patient has sufficient cognitive function in the investigator’s opinion to complete the questionnaires and other activities related to the study
Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
Is, in the opinion of the investigator, a candidate for at least 1 year of continuous ADT for the management of prostate cancer with one of the following clinical disease state presentations:Evidence of biochemical (prostate-specific antigen

Exclusion Criteria:
Any significant cardiovascular conditions per the investigator within 1 month before study entry
Any major cardiovascular or cerebrovascular procedures planned within 1 month after enrollment;
Patients with QT interval corrected for heart rate (QTc) determined using Fridericia’s formula (QTcF; QTcF = QT/[R-R interval {RR}^0.33]) > 470 msec within 6 months of screening
Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg) at the time of screening
Previously received GnRH receptor agonist
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

PSCI 22-156 HCRN BRE17-141

The purpose of this voluntary research study is to see if neratinib, endocrine therapy, and trastuzumab completely shrink breast tumors before having breast cancer surgery. You will need to have the following exams, tests, or procedures: blood draws, ECG, Echo or MUGA, ultrasound, MRI, receive study treatment, and breast biopsy.

Participants will be required to receive study treatments, laboratory assessments, undergo breast biopsy, and radiologic assessments,

Yes
 

Monali Vasekar
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04987203
SITE00001343
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Inclusion Criteria:
Anatomic, clinical stage I-III, invasive breast cancer, greater than 10mm.
HER2-positive (by most recent ASCO-CAP criteria)
ER > 50% and PR > 50%.
Resectable breast cancer in which pre-operative therapy is appropriate (T > 10mm and/or node-positive).
Archival tissue from the diagnostic pre-treatment biopsy is required.

Exclusion Criteria:
Locally advanced or inflammatory breast cancer.
Evidence of metastatic disease.
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial:
Active infection requiring systemic therapy.
Requirement for use of a moderate or strong CYP3A4 inhibitor or inducer during the study
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

NRG-GU007, Randomized Phase II Trial of Niraparib with Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (With Initial Phase I) (NADIR*) (NCT 04037254) (PSCI# 20-104)

The purpose of this study is to compare the usual treatment alone to using the study drug niraparib plus the usual treatment. The addition of niraparib to the usual treatment could prevent your cancer from growing or returning. But, it could also cause side effects, which are described in the risks section below. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To be better, the study approach should increase the chance of remaining cancer free to 50 out of 100 participants after 2 years, or a 20% improvement compared to the usual approach.

This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To be better, the study approach should increase the chance of remaining cancer free to 50 out of 100 participants after 2 years, or a 20% improvement compared to the usual approach.

Yes
 

Joseph Miccio
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Radiation Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04037254
SITE00000907
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Inclusion Criteria:
ECOG performance status of 0 or 1 within 180 days prior to registration
Age is greater than or equal to 18 years old
Pretreatment serum PSA, obtained prior to any androgen suppression therapy and within 180 days of registration
Adequate hematologic, renal, and hepatic function within 90 days prior to registration
Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards

Exclusion Criteria:
PSA > 150 ng/mL
Definitive clinical or radiologic evidence of metastatic disease
Pathologically positive lymph nodes or nodes > 1.5 cm short axis on CT or MR imaging
Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
Prior systemic therapy for prostate cancer; note that prior therapy for a different cancer is allowable
Cancer
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Hershey, PA ,

A011801 THE COMPASSHER2 TRIALS (COMPREHENSIVE USE OF PATHOLOGIC RESPONSE ASSESSMENT TO OPTIMIZE THERAPY IN HER2-POSITIVE BREAST CANCER): COMPASSHER2 RESIDUAL DISEASE (RD), A DOUBLE-BLINDED, PHASE III RANDOMIZED TRIAL OF T-DM1 AND PLACEBO COMPARED WITH T-DM1 AND TUCATINIB (PSCI# 21-155)

The purpose of this study is to compare the usual treatment with T-DM1 alone to T-DM1 plus tucatinib. The addition of tucatinib to the usual treatment could prevent the breast cancer from returning

The purpose of this study is to compare the usual treatment with T-DM1 alone to T-DM1 plus tucatinib. The addition of tucatinib to the usual treatment could prevent the breast cancer from returning.

Yes
 

Cristina Truica
psci-cto@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04457596
SITE00001048
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Inclusion Criteria:
Age = 18 years or older (male or female)
ECOG Performance Status 0-1
Patients must have received neoadjuvant chemotherapy with one of the following regimens: THP, TMP, AC-TH(P); TCH(P); FAC-TH(P), or FEC-TH(P).
HER2-positive breast cancer per pathology
Prior treatment must have consisted = 6 cycles of chemotherapy and HER2-directed therapy, with a total duration of = 12 weeks, including at least 9 weeks of preoperative taxane and trastuzumab with or without pertuzumab (or FDA-approved biosimilars).

Exclusion Criteria:
Prior receipt of T-DM1 in the neoadjuvant setting is not allowed.
Patients with known active and/or untreated Hepatitis B or Hepatitis C or chronic liver disease are ineligible.
Stage IV (metastatic) breast cancer
History of any prior (ipsi- or contralateral) invasive breast cancer within 3 years of registration
Patients with ER+ HER2+ residual invasive disease that is lymph node-negative per the surgical pathology report
Cancer
I'm interested
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See this study on ClinicalTrials.gov
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Study Locations

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Hershey, PA ,