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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

21 Study Matches

Deprexis Study: An online program to reduce depression in MS – a phase III international multicenter randomized controlled trial

An online program to reduce depression in MS – a phase III international multicenter randomized controlled trial
Deprexis Team Roman at mhc147@psu.edu or 814-865-5578
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02740361
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Inclusion Criteria:
Diagnosis of Multiple Sclerosis
Current Depression
No current treatment for depression
Internet access
Between the ages of 18-65
Exclusion Criteria:
No diagnosis of MS
No current psychotherapy for depression
No substantial neurocognitive impairments
Started anti-depressants in the last 2 months
Neurology, Mental & Behavioral Health
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State College, PA

NRG-GU002: Phase II-III Trial Of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or without Adjuvant Docetaxel

Purpose of this study is to compare any good and bad effects of using docetaxel along with the radiation therapy and hormone suppression therapy versus using radiation and hormone suppression therapy alone in men with a high chance of prostate cancer recurrence after surgically removing the prostate.
Daniel Ward at dward1@pennstatehealth.psu.edu or 610-378-2336
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03070886
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Inclusion Criteria:
post-prostatectomy with baseline Gleason ≥ 7
post prostatectomy PSA never undetectable
Any type of radical prostatectomy is permitted
Prior androgren deprivation therapy allowed
Exclusion Criteria:
Clinical or radiologic evidence of metastatic disease
Prior radiotherapy to the prostate
Prior chemotherapy for prostate cancer
Prostatectomy performed greater than 365 days prior to study entry
Cancer
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Reading, PA

Site for A Phase III Randomized Trial Comparing Adjuvant MK3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma

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.
Irina Geier at iug29@psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03712605
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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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Hershey, PA

SAV005-04 "A Phase III, randomized, double-blind, placebo-controlled study of AeroVanc for the treatment of persistent methicillin-resistant Staphylococcus aureus lung infection in cystic fibrosis patients

This is a study that will examine any benefits to use cycles of inhaled vancomycin compared to placebo. Analysis of the information will include lung function results, sputum or throat culture results, questionnaires, and time to use additional antibiotics up to 48 weeks. After the first 24 weeks, all subjects can receive open label study drug for the remaining 24 weeks. There are 13 study visits spanned over 48 weeks.
Diane Kitch at dkitch@pennstatehealth.psu.edu or 717-531-5646
All
All
This study is NOT accepting healthy volunteers
NCT03181932
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Inclusion Criteria:
6 years old and greater
Must have Cystic Fibrosis (CF)
Positive culture for MRSA at screening
FEV1 between 30-90%
Commit to 14 visits over 12 months
Exclusion Criteria:
You may not have allergies to vancomycin
Abnormal liver or kidney function
Inability to tolerate inhaled products
Lung Disease & Asthma
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Hershey, PA

A Phase Ib/11 Study of Propranolol with fixed-dose Pembrolizumab in Patients with Unresectable Stage III and Stage IV Melanoma

This research is being done to find out the safety of propranolol and, identify the maximum tolerated dose of propranolol that can be administered in combination with pembrolizumab in patients with unresectable stage III and stage IV melanoma. This study will evaluate this novel combination of pembrolizumab and propranolol to see what effect it may have on how your cancer responds to the treatment combination.
Irina Geier at igeier@pennstatehealth.psu.edu or 717-531-4300
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03384836
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Inclusion Criteria:
Age >=18 years.
Participants must be newly diagnosed, treatment-naive with histologically confirmed stage IIIC unresectable melanoma or stage IV melanoma.
Have measurable disease per RECIST v1.1
Have an ECOG performance status 0-1
Exclusion Criteria:
Participants who have received previous immunotherapy for any cancer (excluding melanoma) including PD-1/PD-L1 inhibitors but not interferons and CTLA-4 inhibitors.
Participants with chronic autoimmune diseases
Other invasive cancers diagnosed < 3 years back that required systemic treatment. If diagnosed with other invasive cancer ≥ 3 years, should have complete recovery from all systemic toxicity except neuropathy and alopecia
Cancer
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Hershey, PA

Site for 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.
Irina Geier at igeier@pennstatehealth.psu.edu or 717-531-4300
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03811015
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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

Site for 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.
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03367702
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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

Site for Phase III Randomized Trial of Concurrent Chemoradiotherapy with or without Atezolizumab in Localized Muscle Invasive Bladder Cancer (Study SWOG/NRG 1806) (PSCI#19-044)

The purpose of this study is to compare the effects, good and/or bad, of chemotherapy and radiation therapy with or without the use of atezolizumab, which is used to treat bladder cancer. The combination of chemotherapy, radiation therapy and the immunotherapy atezolizumab is considered experimental. If you decide to take part in this study, you will receive combined chemotherapy and radiation therapy which is called “chemoradiotherapy” either with or without the study drug. The chemoradiotherapy you will receive is standard of care and what your doctor thinks is best. You will receive chemoradiotherapy for up to 7 weeks. If you are assigned to the group receiving study drug, you will take the drug for up to 6 months in addition the chemoradiotherapy. Your doctor will continue to follow your condition for up to 5 years after you register to the study, even though you have finished treatment in the first year. Your doctor will watch you for side effects and to see how your cancer affects you. You will have clinic visits at 3 months from the time you stop taking treatment for the first two years and then twice a year for the third year and once a year thereafter until 5 years after you register to the study.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03775265
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Inclusion Criteria:
Patients must have histologically proven, T2-T4a N0M0 urothelial carcinoma of the bladder within 70 days prior to randomization.
Patients must undergo radiological staging within 70 days prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI. Patients must not have evidence of T4bN1-3 disease.
Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meets criteria specified.
Female patients of childbearing potential must have a serum pregnancy test prior to randomization.
Patients must be ≥ 18 years of age.
Exclusion Criteria:
Patient must not have received any systemic chemotherapy for their bladder cancer.
Patients must not have received prior treatment for muscle invasive bladder cancer including neoadjuvant chemotherapy for the current tumor.
Patients must not have a major surgical procedure within 28 days prior to randomization.
Patients must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Patients must have adequate bone marrow function as evidenced by all of the following: ANC ≥ 1,500/microliter (mcL); platelets ≥ 100,000/mcL; Hemoglobin ≥ 9 g/dL. These results must be obtained within 28 days prior to randomization.
Cancer
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Hershey, PA

E4512- A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Purpose of this study is to compare any good and bad effects of using the study drug, crizotinib after completeion of surgery and in some cases after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer.
Michelle Eschbach at meschbach@pennstatehealth.psu.edu or 610-378-2336
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02201992
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Inclusion Criteria:
Patients must have undergone complete surgical resection of their
Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE
ALK positive
Patients must have completed any prior adjuvant chemotherapy or
Exclusion Criteria:
No prior treatment with crizotinib or another ALK inhibitor.
Cancer
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Reading, PA

Site for PD-INHIBITOR (NIVOLUMAB) AND IPILIMUMAB FOLLOWED BY NIVOLUMAB VS. VEGF TKI CABOZANTINIB WITH NIVOLUMAB: A PHASE III TRIAL IN METASTATIC UNTREATED RENAL CELL CANCER [PDIGREE] (PSCI# 19-109) (A031704)

The purpose of this study is to compare the usual treatment of advanced kidney cancer (treatment with ipilimumab and nivolumab followed by nivolumab alone) to the usual treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib. 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 adding cabozantinib to nivolumab can increase the percentage of patients alive at 3 years from 60% to 70%.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03793166
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Inclusion Criteria:
Histologic documentation of renal cell carcinoma with clear cell component
Age ≥ 18 years
Karnofsky performance status greater than or equal to 70%
Hemoglobin ≥8 g/dL
Platelet Count ≥ 100,000/mm3
Exclusion Criteria:
No prior previous systemic therapy for renal cell carcinoma.
No cancer therapy less than 28 days prior to registration; this includes radiation therapy.
Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.
No history of HIV or active hepatitis B/C, or tuberculosis
No uncontrolled hypertension (systolic BP >150mmHg or diastolic BP
Cancer
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Hershey, PA

Site for Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin

The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment drug (durvalumab), to the usual therapy of radiation plus the drug (cetuximab) in patients with head and neck cancer who cannot take the drug cisplatin.
Irina Geier at iug29@psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03258554
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Inclusion Criteria:
squamous cell carcinoma
18 or older
Adequate hematologic function
Adequate hepatic function
Adequate renal function
Exclusion Criteria:
invasive malignancy within the past 3 years
Prior radiotherapy
Prior immunotherapy
Major surgery within 28 days prior to Step 1 registration
Uncontrolled hypertension
Cancer
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Hershey, PA

A Phase III Randomized Open Label Study to Compare NKTR-214 Combined with Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients with Previously Untreated Advanced Renal Cell Carcinoma (PSCI 18-122)

The purpose of the study is to compare how well the drug called NKTR-214 works when combined with the other drugs: nivolumab, sunitinib, and cabozantinib in patients with renal cell carcinoma.
Kathleen Rizzo at krizzo@pennstatehealth.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03729245
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Inclusion Criteria:
18 years or older
Karnofsky Performance Status of at least 70
advanced or metastatic renal carcinoma
No prior systemic therapy
No active brain metastases
Exclusion Criteria:
Use of an investigational agent or an investigational device within 28 days of randomization
autoimmune disease
History of organ or tissue transplant
Prior major surgery or radiotherapy within 14 days
Any tumor invading the major blood vessels
Cancer
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Hershey, PA

A Multicenter Phase 2, Open-Label Study of Intratumoral Tavokinogene Telseplasmid (tavo, pIL-12) plus Electroporation in Combination with Intravenous Pembrolizumab in Patients with Stage III/IV Melanoma who are Progressing on either Pembrolizumab or Nivolumab Treatment (PISCES)

The purpose of this voluntary research study is to find out what effects, good and/or bad, the combination of a type of gene therapy treatment called plasmid electroporation and pembrolizumab has on your cancer.
Irina Geier at igeier@pennstatehealth.psu.edu or 717-531-8678
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03132675
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Inclusion Criteria:
Pathologically documented unresectable melanoma, American Joint Committee on Cancer (AJCC) version 8, Stage III or IV
Subjects must be refractory to anti-PD-1 monoclonal antibodies (pembrolizumab or nivolumab either as monotherapy or in combination with other approved checkpoint inhibitors or targeted therapies according to their approved label
Resolution/improvement of anti-PD1 mAb-related AEs (including immune related AEs; irAEs) back to Grade 0-1
BRAF V600 mutation-positive melanoma could have received standard of care targeted therapy for advanced or metastatic disease
Has a performance status of 0 or 1 on the ECOG Performance Scale
Exclusion Criteria:
Subject has disease that is suitable for local therapy administered with curative intent
Clinically active CNS metastases
Subject with a diagnosis of uveal melanoma
Subject who had an allogenic tissue/solid organ transplant
Subjects with electronic pacemakers or defibrillators
Cancer
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Hershey, PA

Site for A RANDOMIZED PHASE III DOUBLE BLINDED PLACEBO CONTROLLED TRIAL OF ASPIRIN AS ADJUVANT THERAPY FOR HER2 NEGATIVE BREAST CANCER: THE ABC TRIAL.

This is a drug study with a primary outcome of testing aspirin as therapy versus a placebo pill for patients for breast cancer.
Lea Russell at lmay1@psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02927249
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Inclusion Criteria:
Histologic documentation of women or men with HER2 negative breast carcinoma and free of recurrence.
Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined by the treating physician, is allowed.
Age > 18 and < 70 years of age.
ECOG performance status 0-2.
Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can be enrolled as long as the ulcers did not cause bleeding requiring a blood transfusion/major intervention.
Exclusion Criteria:
No history of GI bleeding requiring a blood transfusion, endoscopic or operative intervention.
No history of any prior stroke (hemorrhagic or ischemic).
No concurrent anticoagulation with warfarin, heparin/heparin analogues, clopidogrel, direct thrombin inhibitors, or direct factor XA inhibitors.
No history of atrial fibrillation or myocardial infarction.
No history of grade 4 hypertension, defined as hypertension resulting in lifethreatening consequences
Cancer
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Hershey, PA

A Phase III Randomized, Open Label, Multi-center Study of the Safety and Efficacy of Apixaban for Thromboembolism Prevention versus No Systemic Anticoagulant Prophylaxis during Induction Chemotherapy in Children with Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoma (T or B cell) Treated with Pegylated Asparaginase

A study to confirm and expand information on safety and effectiveness of apixaban to prevent blood clots as compared to no prevention treatment in children with newly diagnosed leukemia and lymphoma. This is a randomized study so patients will be selected by chance to be in either the group that receives apixaban or the group that does not receive apixaban.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT02369653
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Inclusion Criteria:
New diagnosis of leukemia (de novo ALL) or lymphoma (T or B cell).
An acceptable planned induction chemotherapy.
One year of age and older to less than 18 years of age.
Able to take oral medication or have it given through a tube.
Exclusion Criteria:
Had a blood clot in the past 3 months.
Known inherited bleeding disorder.
Children's Health, Cancer
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Hershey, PA

A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study.

This study is for patients with Crohn's disease which involves an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD). The purpose of this study is to find out: 1) How well the study drug works at a single dose compared to a placebo; 2) how safe and tolerable the study drug is in patients with fistulizing CD.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03279081
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Inclusion Criteria:
Diagnosis of Crohn's Disease for at least 6 months
Presence of complex perianal fistulas
Clinically controlled, non active or mildly active CD during the last 6 months
Patients whose perianal fistulas were previously treated and have shown an inadequate response
Exclusion Criteria:
Any major surgery of the GI tract within past 6 months
Patients without prior specific treatment for perianal complex fistulas
Patients with diverting stomas
Patients with active, uncontrolled infection requiring IV antibiotics
Patients with allergies or hypersensitivity to penicillin or aminoglycosides, local anesthetics or MRI contrast
Infectious Diseases & Immune System, Digestive Systems & Liver Disease
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Hershey, PA

A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The dal-GenE trial

The dal-GenE trial is evaluating the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with a documented recent heart attack or hospitalization due to severe coronary artery disease. Dalcetrapib is an investigational drug (not approved by the United States Food and Drug Administration) that has been evaluated in several large clinical trials, most notably dal-OUTCOMES, a study of over 15,000 patients which was designed to evaluate its effect in patients with recent ACS. The results of this large study demonstrated that treatment with dalcetrapib did not change the risk of cardiovascular disease in the majority of patients with recent ACS. However, after the study was over, researchers identified a group of patients that had a significant benefit. Specifically, the group of patients who had a particular variant (AA) of a gene that all humans share (ADCY9) had their risk of having another cardiovascular event reduced by 39%. Approximately 1 in 5 patients studied had this genetic variant. Those individuals with the AA variant of the will continue in the study and will be started on study drug 4-12 weeks after their index event.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02525939
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Inclusion Criteria:
Male or female age 45 or greater
Admitted to hospital due to blockages in arteries of the heart
Exclusion Criteria:
Bypass surgery to treat your most recent heart event
Severe liver and/or kidney disease
Hemoglobin A1c greater than 10%
Triglyceride level greater than 500mg/dL
Heart & Vascular
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Hershey, PA

A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE).

This is a drug study that will examine the drug Ribociclib with endocrine therapy versus just endocrine therapy in patients with early breast cancer.
Kathleen Rizzo at krizzo@pennstatehealth.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03701334
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Inclusion Criteria:
Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization
Patient has breast cancer that is positive for ER and/or PgR
Patient has HER2-negative breast cancer defined as a negative
Patient has available archival tumor tissue from the surgical specimen, for submission to a central laboratory.
If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines
Exclusion Criteria:
Patient has received any CDK4/6 inhibitor
Patient has received prior treatment with tamoxifen, raloxifene or AIs
Patient has received prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin.
h a known hypersensitivity to any of the excipients of ribociclib and/or ET (
Patient with distant metastases of breast cancer beyond regional lymph nodes
Cancer
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Hershey, PA

Site for EA9161: A Randomized Phase III Study of the addition of Venetoclax to Ibrutinib and Obinutuzumab versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)

The is a drug study to compare the progression free survival of the three drug combination Ibrutinib-Obinutuzumab-Venetoclax (IOV) to Ibrutinib-Obinutuzumab (IO) in untreated CLL patients younger than 70 years of age.
Michelle Stojanovic at mstojanovic1@pennstatehealth.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03701282
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Inclusion Criteria:
Diagnosis of CLL according to the NCI/IWCLL criteria or SLL according to the WHO criteria
Negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy
Age ≥ 18 years and < 70.
ECOG performance status between 0-2.
Life expectancy of ≥ 12 months.
Exclusion Criteria:
No deletion of 17p13 on cytogenetic analysis by FISH
No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment.
No current use of corticosteroids.
No previous autoimmune complications
No other active primary malignancy
Cancer
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Hershey, PA

Site for 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.
Irina Geier at igeier@pennstatehealth.psu.edu or 717-531-4300
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03952585
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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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Location
Hershey, PA

Site for Phase III Study of Daratumumab/rHuPH20 (NSC-810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study) (PSCI# 19-079) (S1803)

This study is being done to answer the following questions: 1. Will adding the drug daratumumab/rHuPH20 to the usual maintenance treatment with lenalidomide after stem cell transplant help multiple myeloma patients survive longer? 2. For patients who have no evidence of multiple myeloma in their bone marrow (patients who do not have “minimum residual disease” [MRD-negative]), should maintenance therapy be stopped after 2 years? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your multiple myeloma. The usual approach is defined as care most people get for multiple myeloma.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04071457
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Inclusion Criteria:
Patients must have had a confirmed diagnosis of symptomatic multiple myeloma (See Section 4.1) that required systemic induction therapy prior to autologous stem cell transplantation (ASCT).
Patients with disease measurable by serum light chain assay alone are eligible (defined as ≥ 100 mg/L on involved light chain).
Patients must be ≥ 18 and ≤ 75 years of age at time of registration to Step 1.
Patients must have history and physical exam within 28 days prior to registration.
Patients must have Zubrod Performance Status ≤ 2.
Exclusion Criteria:
Patients with smoldering myeloma are not eligible
Patients must not have any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction.
Patients must not have progressive disease at any time prior to registration.
Patients must not be refractory or intolerant to either lenalidomide or daratumumab/rHuPH20.
Patients must not have moderate or severe persistent asthma within the past 2 years and must not have currently uncontrolled asthma of any classification.
Cancer
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Study Locations

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Location
Hershey, PA