Search Results Within Category "Cancer"
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.
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.
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.
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.
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
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.
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.
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
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
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.
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
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
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
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
Previous treatment with mTOR inhibitors, PD-1, PD-L1, or CTLA-4 inhibitors for RCC
History of active primary immunodeficiency
History of organ transplant
PSCI 21-176 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab versus Placebo in Combination with Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients with Acute MyeloidLeukemia Who Are Ineligible for Intensive Chemotherapy
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
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
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
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.
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
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
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.
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
Life expectancy < 3 months
Pregnant or lactating
Symptomatic or untreated brain metastases
Known hypersensitivity to any of the components of seribantumab
PSCI 22-124 MAIN-CAV: PHASE III RANDOMIZED TRIAL OF MAINTENANCE CABOZANTINIB AND AVELUMAB VS MAINTENANCE AVELUMAB AFTER FIRST-LINE PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH METASTATIC UROTHELIAL CANCER
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.
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
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.
A Randomized Phase II/III Trial of De-intensified Radiation Therapy for Patients with Early-Stage, P16-Positive, Non-Smoking Associated 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.
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
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)
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.
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
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
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.
You are positive for certain changes in your genes which we will test you for as needed
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.
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
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).
EA6174: STAMP: Surgically Treated Adjuvant Merkel Cell Carcinoma with Pembrolizumab, a Phase III Trial
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.
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
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.
PSCI-22-042: A Phase 2, Open Label Trial to Evaluate Safety of Epcoritamab monotherapy in Subjects with Relapsed or Refractory B Cell Non Hodgkin Lymphoma when Administered in the Outpatient Setting
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
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
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.
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
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.
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,
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, zoom 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 zoom and a zoom 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).
Over the age of 40
English Speaking
have undergone a total glossectomy
currently have an upper respiratory infection, sinus infection, or ear infection
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).
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.
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
(22-070) Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US) (NRG-GI008)
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.
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
Tumor-related bowel perforation
Synchronous primary rectal and/ or colon cancers
Active seizure disorder uncontrolled by medication
Active or chronic infection requiring systemic therapy
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
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
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.
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.
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
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.
Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination with Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open-label Phase IA/IB/II Study (PSCI# 21-059)
The main purpose of the study is to determine whether the study drug, ONC-392, either given alone or in combination with a standard of care drugs, is safe and tolerated and how it is processed in the blood of patients with tumors that cannot be removed (unresectable) or has spread (metastasized) to a different part of the body.
If you take part in this research, you will be responsible for: • Following all instructions given to you. If you are unsure about what you are supposed to do, ask your study team.• Coming to all your scheduled study visits and procedures. Let your study team know as soon as possible if you are not able to attend a study visit so that they can work with you to make other arrangements.• Informing the study team of all information regarding your health and medications and any health changes, procedures, emergency room visits or hospitalizations.• Not taking any other drugs or medicines unless the study doctor has approved them beforehand. Consult with the study doctor before starting any new medications or over the counter herbal/natural supplements that you buy without a prescription. • If you see a doctor or health care provider outside the research study, telling that doctor or health care provider that you are in an investigational research study.• Not participating in another investigational research study at the same time.• Telling the study staff if you wish to stop taking part in the study.• Telling the study staff immediately if you are pregnant, suspect to be pregnant or have not followed the required birth control measures.Your responsibility to follow these instructions is important to your safety. It also helps the researchers understand how the study drug works.
Patient can be male or female; female participants must have a negative pregnancy test
Patient must have an ECOG score <= 1
Patient must have a histological or cytological diagnosis of solid tumors and progressive metastatic disease or progressive locally advanced disease
Patient must have adequate organ function as determined by laboratory tests
Patients who are currently enrolled in any other clinical trial testing an investigational drug or device, or with concurrent other systemic cancer therapeutics
Patients who are on chronic systemic steroid therapy at doses higher than 10 mg/day prednisone or equivalent for at least 4 weeks prior to treatment
Patients who have active brain metastases or leptomeningeal metastases
Patients who have an active infection requiring systemic IV antibiotics within 14 days prior to administration of ONC-392 or combined ONC-392 and Pembrolizumab
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.
Ages ≥2 and <21
Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia (AML) (PrE0905)
The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving standard combination chemotherapy for a particular change in AML of their leukemia cells (called a mutation) in a gene called FLT3.
There are three phases to the study, You will have physical exams, imaging, bone morrow aspiration and biopsy. You may receive treatment for approximately 9 months (Induction and Consolidation). After you have finished taking the study drug (gilteritinib or midostaurin), the study doctor will ask you to return for a follow-up visit about one month after your last dose of study therapy (End of Treatment).
Verified confirmation that blasts are myeloid
Verified NPM1 mutation status
Must have an ECOG performance status of 0-3
Must have adequate organ function as measured by criteria
May not have known active Central Nervous System (CNS) leukemia
Not a woman of childbearing potential (WOCBP) or who agrees to follow the contraceptive guidance
May not have a history of Long QT Syndrome
May not have evidence of uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, or congestive heart failure
A Phase II, Randomized, Open-Label Three-Arm Clinical Study To Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination with Pembrolizumab (MK-3475) versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) that have Progressed after Platinum Therapy and Immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009)
This study is designed to compare pembrolizumab plus lenvatinib as a combination therapy and standard of care (SOC) chemotherapy and see if its safe and effective for patients with recurrent or metastatic head and neck squamous cell carcinoma.
If you choose to participate in this study, there will be different phases that will require you to come to the study site. These phases are Screening, Treatment and Follow-up. During these phases you will undergo various tests and procedures such as a physical exam, ECGs, CT or MRI scans, provide a biopsy and blood and urine samples.
Have histologically confirmed recurrent (not amenable to curative treatment with local and/or systemic therapies) or metastatic (disseminated) HNSCC
Have experienced disease progression at any time during or after treatment with a platinum-containing (eg, carboplatin or cisplatin) regimen with or without cetuximab.
Have submitted pre-study imaging that demonstrates evidence of disease progression based on investigator review of at least 2 pre-study images per RECIST 1.1,
Have provided tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not adequate) not previously irradiated.
Has a history of re-irradiation to any head and neck sites of disease including the cervical, infraclavicular or supraclavicular lymph nodes for head and neck cancer.
Has a life expectancy of less than 3 months and/or has rapidly progressing disease
Has any evidence of symptoms or signs of active tumor bleeding within 6 months prior to randomization
Has a history of (noninfectious) pneumonitis that required systemic steroids, or current pneumonitis/interstitial lung disease.
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.
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.
Female patients who are lactating are not eligible unless they agree not toe breast feed.
Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination withContinued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer Big Ten Cancer Research Consortium BTCRC-BRE19-409
A Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination with Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer
We are asking you to take part in this voluntary research study because you have breast cancer that is estrogen and progesterone receptor positive and is HER2 receptor negative. Your breast cancer also spread outside your breast (metastatic) to other areas of your body. We are asking you to take part in this research study because your cancer has a genetic mutation in a pathway called PI3K and your tumor progressed while you were receiving hormone therapy.
Confirmed metastatic or unresectable breast cancer.
Has confirmed HER2 negative breast cancer.
Treatment with any investigational drug within 14 days prior to registration.
Currently documented clinically active pneumonitis.
History of acute pancreatitis within 1 year of screening
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.
Completed upfront therapy with at least 4 cycles of aggressive multi-drug chemotherapy
Currently receiving another investigational drug
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.
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
Absolute contraindication to exercise
Pregnant women
Patients with relapsed cancer
atients who have undergone allogeneic stem cell transplant
A Pilot Study to evaluate the pharmacokinetic, pharmacodynamic, and resistance profile to trametinib and dabrafenib in BRAF-V600E mutated recurrent gliomas
This research is being done to understand how much of two drugs (dabrafenib and trametinib) is able to enter brain tumors and how well the drugs are able to turn off this pathway in brain tumors. The study will also look at how tumors lose sensitivity to this treatment. People with primary brain tumors who are already taking dabrafenib and trametinib and who need a brain surgery are eligible for this study. Biospecimens (tissue, blood, and cerebrospinal fluid (CSF)) taken during the surgery will help us understand how much of these two study drugs actually get into the brain, their effect, and how the tumors become resistant to treatment.
Subjects must have a history of primary brain tumor (including but not limited to glioblastoma (GBM), anaplastic astrocytoma (AA), anaplastic ganglioglioma (AG), and anaplastic pleomorphic xanthoastrocytoma (PXA)).
Subjects must have a BRAF-V600 mutation identified in previous tissue analysis (may be IHC or PCR based). Allowable mutations include V600E, V600K, V600R, and V600D.
Subjects must be taking dabrafenib at a dose of at least 50mg twice daily (adults only) and / or trametinib at a dose of at least 1mg daily (adults only) for at least 7 days prior to surgery as prescribed by their treating physician.
Subjects must be undergoing surgery for clinical purposes
Subjects who are receiving any other investigational agents or chemotherapeutic agents.