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Suggestions within category "Cancer"


78 Study Matches

CCTG MA.39- A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

Purpose of this study is to compare any good and bad effects of not using regional radiotherapy to using radiotherapy. The study will help researcher learn if not giving regional radiotherapy is just as good as using regional therapy to treat node positive breast cancer in women.
Michelle Eschbach at meschbach@pennstatehealth.psu.edu or 610-378-2336
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03488693
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Inclusion Criteria:
Estrogen Receptor Positive / Her2 Negative Breast Cancer
No evidence of metastasis
1
•3 positive lymph nodes
May have had breast conserving surgery or mastectomy
40 years of age or older
Exclusion Criteria:
Nodal disease limited to micromets or isolated cells
History of ipsilateral breast cancer or DCIS
Synchronous or contralateral breast cancer
pT3 or pT4 disease
Neoadjuvant Chemotherapy for breast cancer
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

Impact of Prehabilitation in Oncology Via Exercise- Bone Marrow Transplant

The purpose of this study is to assess feasibility, safety, and acceptability of a prehabilitation exercise program for hematopoietic stem cell transplant patients. The second purpose of this study is to assess changes in physical function, fatigue, pain, quality of life, and transplant-related symptoms and complications in hematopoietic stem cell transplant patients.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03886909
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Inclusion Criteria:
Hematological cancer (e.g. Acute Myeloid Leukemia, Multiple Myeloma, Chronic Lymphocytic Leukemia, etc.)
Females and males, 18 years of age and older
Fluent in written and spoken English
Scheduled for an inpatient autologous or allogeneic stem cell transplant at Penn State Cancer Institute
At least 2 weeks until scheduled transplant
Exclusion Criteria:
Not fluent in written and spoken English
Severe cardiovascular issues
Uncontrolled hypertension
Transplant physician does NOT approve
Cancer
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Harrisburg, PA
Hershey, PA

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large B-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release

This study is to provide access to CTL019 for ALL or large B-cell lymphoma patients who are either out of manufactured specifications or out of specification leukapheresis product who would otherwise not be able to be treated with CTL019 due to commercial restrictions. This means these manufactured cells are not able to be used commercially and insurance will not pay or contribute to paying for the product.
Jen Petrask at jpetrask@pennstatehealth.psu.edu or 717-531-8678
All
All
This study is NOT accepting healthy volunteers
NCT03601442
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Inclusion Criteria:
patient to be treated has a serious or life threatening disease or condition and no comparable alternative therapy is available
patient is not eligible or able to enroll in a clinical trial
potential benefit to justify potential risk of the treatment use
provision of the investigational product will not interfere with the initiation, conduct or completion of a Novartis clinical trial
access to provision of investigational product is allowed per local laws and regulations
Exclusion Criteria:
product can be commercially manufactured per the specifications
evidence of CD19 negative disease in patients with B-cell ALL
active Hepatitis B, active or latent Hepatitis C, or HIV positivity
uncontrolled active infection or inflammation
pregnant or nursing women
Cancer
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Hershey, PA

A Phase 1/2 Study of Lenvatinib in combination with Everolimus in Recurrent and Refractory Pediatric Solid Tumors, including CNS tumors

A study of the safety of levatinib with everolimus for children with solid tumors and central nervous system tumors that returned or did not respond to previous treatment.
Suzanne Treadway at streadway@pennstatehealth@psu.edu or 717-531-3097
All
All
This study is NOT accepting healthy volunteers
NCT03245151
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Inclusion Criteria:
You have Ewing sarcoma/pPNET or Rhabdomyosarcoma or a HGG that has come back or is not responding to treatment
Your cancer can be measured by certain criteria
You are ≥2 years and ≤21 years of age
Exclusion Criteria:
You have lymphoma
You have a wound or injury that won't heal
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

Repotrectinib for cancer that has returned or is not responding to treatment
Suzanne Treadway at streadway@pennstatehelath.psu.edu or 717-531-3097
All
All
This study is NOT accepting healthy volunteers
NCT04094610
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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

3D-PREDICT REGISTRY: 3D Prediction of Patient-specific Response using Ex vivo Interrogation of Live Cells from Tumors

Patients are being asked to participate in this study because they may have one of the following: Brain Cancer (high-grade gliomas (HGG) that are limited to Glioblastoma Multiforme (GBM) or Anaplastic Astrocytoma (AA)). This study will collect data for a registry that records how a patient's cancer tissue responds to different types of approved chemotherapy drugs. The results of the responses will be shared with the patient's physician. The purpose of this study is to measure the accuracy of new investigational laboratory tests which could predict which chemotherapies are most active to each individual patient’s tumor. KIYATEC has validated a test, the Ex-Vivo 3-Dimensional Drug Response Assay (EV3D, the Assay) prior to use in this study. In this study, KIYATEC will establish the clinical correlation and utility of the Assay in various cancer subtypes.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03561207
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Inclusion Criteria:
Age 18 years and older
Diagnosis of or suspected diagnosis of glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA)
Patient must undergo elective surgery or biopsy to remove tumor tissue
Consideration as a candidate for systemic therapy with cytotoxic chemotherapy, targeted small molecule inhibitors or immunotherapy
Exclusion Criteria:
Age of <18 years
Do not have a diagnosis of or suspected diagnosis of glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA)
Patient will not have surgery or a biopsy as part of routine clinical practice
Patient has known active cancer metastatic to the brain except for patients with brain metastases that have been treated and are considered stable
Patient refuses to have the assay performed on their tissue
Neurology, Cancer
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Hershey, PA

IMpact of PRehabilitation in Oncology Via Exercise – Breast cancer

It is well known that breast cancer patients suffer from many cancer- and treatment-related side effects that all worsen overall quality of life. Besides dealing with existing treatment-related side-effects, there is the idea of prehabilitation a process on the cancer continuum of care that occurs between the time of cancer diagnosis and the beginning of acute treatment. IMPROVE-B will evaluate an exercise prehabilitation approach with regard to safety, feasibility, acceptability and effectivity in breast cancer patients (n=30) prior surgery.
Joachim Wiskemann at jwiskema@phs.psu.edu or 717-531-0003, ext=289736
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Scheduled for breast cancer surgery
Not metastatic (stage <4)
more than 2 weeks till surgery
Exclusion Criteria:
Receiving neoadjuvant chemotherapy or radiotherapy
Pregnant
• Engaging in systematic intense exercise training (at least 1h twice per week)
Cancer
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Hershey, PA

Risk-based, response-adapted, Phase II open-label trial of nivolumab + brentuximab vedotin (N + Bv) for children, adolescents, and young adults with relapsed/refractory (R/R) CD30 + classic Hodgkin lymphoma (cHL) after failure of first-line therapy, followed by brentuximab + bendamustine (Bv + B) for participants with a suboptimal response. CheckMate 744: CHECKpoint pathway and nivolumab clinical Trial Evaluation

This is is a Phase 2, open-label study of nivolumab and brentuximab for children and young adults with relapsed/refractory classic Hodgkin lymphoma.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
This study is NOT accepting healthy volunteers
NCT02927769
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Inclusion Criteria:
Must be 5-30 Years of Age
A confirmed diagnosis of Classic Hodgkin Disease
Failed or did not respond to initial treatment
Exclusion Criteria:
A previous allogeneic stem cell transplant
Received certain antibody therapies in the past
Cancer
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Hershey, PA

CUFF Study: Characterization of Upper Limb Function following Mastectomy and Reconstruction for Breast Cancer

This is an observational study that will provide information describing the relationships between type of breast reconstruction and shoulder/upper extremity function and perceived health-related quality of life (HRQOL) for breast cancer survivors. This study will obtain measurements of arm strength and mobility and use self-report questionnaires to evaluate patient quality of life and satisfaction with treatment. Outcomes across three patient groups will be compared, including patients who undergo mastectomy with: 1) no reconstruction; 2) reconstruction with implants; and 3) reconstruction with autologous flaps.
Meghan Vidt at mzv130@psu.edu or 814-865-6885
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Women aged 18-79 years old
Plan to undergo mastectomy as a part of breast cancer treatment
Mastectomy with or without secondary reconstruction
Exclusion Criteria:
Men
Women who do not plan to have mastectomy as a part of their breast cancer treatment
History of a stroke or neuromuscular disorder (e.g. Parkinson's disease, tremor)
Severe arthritis that affects how you move
Any condition that affects memory (e.g. Alzheimer's disease, dementia)
Cancer
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Hershey, PA

Digital intervention to promote physical activity and improve cardiovascular health among cancer survivors

This is a behavioral study that will examine changes in physical activity and vascular health in response to a digital tool (app) that will appear on participant's lock screen of their Android phone. Participants will be asked to use this app for 3 months and to wear a Fitbit device continuously throughout the study. Participants will be asked to complete questionnaires, participate in fitness testing and measures of cardiovascular health at 3 months and 6 months after baseline assessments.
Jenna Gilchrist at gilchrist@psu.edu or 814-865-7935
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03953326
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Inclusion Criteria:
Age 18-65 years
Diagnosis of breast cancer, leukemia, or lymphoma <15 yrs
Completed chemotherapy with cardiotoxic anthracycline-based agents 1+ year ago
English-proficiency
Own & use smartphone with Android operating system
Exclusion Criteria:
Currently receiving curative treatment for cancer
90+ min/week moderate (or greater) intensity PA
Require an assistive device for mobility or has any other condition that may limit or prevent participation in moderate-intensity physical activity
Current medications which could conceivably alter the cardiovascular or thermoregulatory control or responses (e.g. beta blockers, calcium channel blockers, angiotensin receptor blockers)
Pregnant or planning to become pregnant in the next 6 mos/breastfeeding
Cancer
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State College, PA

A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Erdafitinib plus JNJ-63723283 (Cetrelimab), an Anti-PD-1 Monoclonal Antibody, in Subjects with Metastatic or Locally Advanced Urothelial Cancer with Selected FGFR Gene Alterations

The purpose of this study is to see whether taking the drug Erdafitinib and the drug JNJ-63723283 is safe and effective in treating patients with advanced bladder cancer.
Kathleen Rizzo at kar23@psu.edu or 717-531-0003, ext=289630
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03473743
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Inclusion Criteria:
≥18 years of age.
Histologic demonstration of transitional cell carcinoma of the urothelium.
Stage IV disease (metastatic or Locally Advanced cT4b, N+, or M+ cancer).
Meet appropriate molecular eligibility criteria
Documented progression of disease per RECIST 1.1, defined as any progression that requires a change in treatment, prior to randomization.
Exclusion Criteria:
Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b, subjects who have received the following prior antitumor therapy
Chemotherapy within 3 weeks of Cycle 1 Day 1
Prior anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy
Active malignancies (ie, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that are considered completely cured).
Symptomatic central nervous system metastases.
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

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

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

A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma (CSCC) (PSCI 18-112)

This study is a comparison of disease-free survival of patients with high-risk cutaneous squamous cell carcinoma (CSCC) when treated with a medication (cemiplimab) versus those treated with placebo after already having surgery and radiation therapy.
Irina Geier at igeier@pennstatehealth.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03969004
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Inclusion Criteria:
High risk cutaneous squamous cell carcinoma
Post resection and curative intent post-operative Radiation Therapy within 2 to 6 weeks of randomization
Adequate hepatic, renal, and bone marrow function as defined in the protocol
Exclusion Criteria:
Patients with blood cancer (hematologic malignancies) or other malignancies
Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
Significant autoimmune disease that required treatment with systemic immunosuppressive treatments (including corticosteroids)
Has had prior systemic anti-cancer immunotherapy for cutaneous squamous cell carcinoma
Cancer
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Hershey, PA

A081105: Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

Purpose of this study is to compare any good or bad effects patients may have when treated with their standard treatment versus patients treated with standard treatment plus erlotinib (investigational drug)
Michelle Eschbach at meschbach@pennstatehealth.psu.edu or 610-378-2336
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02193282
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Inclusion Criteria:
Patient must be screened in the A151216 protocol
Must have EGFR EXON 19 deletion or L858R mutuation
Must have completed recovery from surgery and standard post operative therapy
ECOG performance status 0-1
Exclusion Criteria:
Patients must not have received neoadjuvent therapy
Cancer
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Reading, 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