Below please find a list of studies actively recruiting volunteers at one of the following GHUCCTS institutions: Georgetown University, Howard University, MedStar Health Research Institute, or Washington DC VA Medical Center. Please enter your search criteria below to help find a study for you. If you have any questions, please email us or call us at 301-560-2963.


355 matching studies

Sponsor Condition of Interest
S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With...
Southwest Oncology Group Colon Adenocarcinoma ERBB2 Gene Amplification Rectal Adenocarcinoma Recurrent Colon Carcinoma Recurrent Rectal Carcinoma
This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to cetuximab and irinotecan hydrochloride in treating patients with HER2/neu amplified colorectal cancer that has spread from where it started to other places in the body and cannot be removed... expand

This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to cetuximab and irinotecan hydrochloride in treating patients with HER2/neu amplified colorectal cancer that has spread from where it started to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab and pertuzumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cetuximab and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trastuzumab and pertuzumab may work better compared to cetuximab and irinotecan hydrochloride in treating patients with colorectal cancer.

Type: Interventional

Start Date: Oct 2017

open study

TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast...
Georgetown University Breast Cancer
This is a multi-institutional pilot trial for patients with advanced breast cancer. The trial is designed to assess the safety and tolerability of induction talazoparib followed by combination of talazoparib and avelumab. As an exploratory endpoint, the study team will evaluate... expand

This is a multi-institutional pilot trial for patients with advanced breast cancer. The trial is designed to assess the safety and tolerability of induction talazoparib followed by combination of talazoparib and avelumab. As an exploratory endpoint, the study team will evaluate the immunomodulatory effects of induction talazoparib followed by the combination of talazoparib and avelumab in patients with advanced breast cancer.

Type: Interventional

Start Date: Apr 2019

open study

The Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma and/or DCIS in Patients Diagnosed...
Dana-Farber Cancer Institute Flat Epithelia Atypia Intraductal Papilloma Without Atypia
This research study is studying a surgical intervention to rule out the presence of cancer in participants that have been diagnosed with flat epithelial atypia (FEA) or intraductal papilloma without atypia (IPWA) by core needle biopsy. expand

This research study is studying a surgical intervention to rule out the presence of cancer in participants that have been diagnosed with flat epithelial atypia (FEA) or intraductal papilloma without atypia (IPWA) by core needle biopsy.

Type: Interventional

Start Date: Sep 2015

open study

Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions...
W.L.Gore & Associates Aortic Aneurysm, Thoracic Aorta; Lesion
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta. expand

The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.

Type: Interventional

Start Date: Aug 2016

open study

A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors
Bristol-Myers Squibb Colorectal Cancer Pancreatic Cancer
This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or nivolumab in participants with metastatic colorectal and pancreatic cancers. expand

This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or nivolumab in participants with metastatic colorectal and pancreatic cancers.

Type: Interventional

Start Date: Aug 2017

open study

Negative Pressure Wound Therapy With Instillation of Saline Solution Versus Collagenase Ointment in Full-thickness...
KCI USA, Inc. Wounds and Injuries Wound Healing Granulation Tissue
Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds. expand

Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds.

Type: Interventional

Start Date: Dec 2018

open study

I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
QuantumLeap Healthcare Collaborative Breast Neoplasms Breast Cancer Breast Tumors Angiosarcoma
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery... expand

The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.

Type: Interventional

Start Date: Mar 2010

open study

Niraparib With Standard Combination Radiation Therapy and Androgen Deprivation Therapy in Treating Patients...
NRG Oncology Prostate Adenocarcinoma Stage IIC Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IIIA Prostate Cancer AJCC v8 Stage IIIB Prostate Cancer AJCC v8
This phase II trial studies the side effects and best dose of niraparib, and to see how well it works in combination with standard of care radiation therapy and hormonal therapy (androgen deprivation therapy) in treating patients with prostate cancer that has a high chance of... expand

This phase II trial studies the side effects and best dose of niraparib, and to see how well it works in combination with standard of care radiation therapy and hormonal therapy (androgen deprivation therapy) in treating patients with prostate cancer that has a high chance of coming back (high risk). Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding niraparib to the usual treatments of radiation therapy and hormonal therapy may lower the chance of prostate cancer growing or returning.

Type: Interventional

Start Date: Jun 2019

open study

Suvorexant and Sleep's Benefits to Therapeutic Exposure for Posttraumatic Stress Disorder
Howard University Posttraumatic Stress Disorder
The purpose of this study is to examine effects of blocking the orexin system with suvorexant after exposure-based intervention for posttraumatic stress disorder (PTSD) on sleep, PTSD symptoms, and intersession habituation. expand

The purpose of this study is to examine effects of blocking the orexin system with suvorexant after exposure-based intervention for posttraumatic stress disorder (PTSD) on sleep, PTSD symptoms, and intersession habituation.

Type: Interventional

Start Date: Jan 2017

open study

Study of Adjuvant Ipilimumab and Nivolumab in Subjects With High-risk Ocular Melanoma
Suthee Rapisuwon Melanoma Ocular Melanoma
This is an open-label, multi-site, single-arm Phase 2 study of adjuvant nivolumab combined with ipilimumab for the treatment of adult subjects with completely treated high-risk ocular melanoma, as defined in eligibility criteria, without evidence of metastatic disease. All patients... expand

This is an open-label, multi-site, single-arm Phase 2 study of adjuvant nivolumab combined with ipilimumab for the treatment of adult subjects with completely treated high-risk ocular melanoma, as defined in eligibility criteria, without evidence of metastatic disease. All patients enrolled to the study will be treated with nivolumab 240 mg IV every 2 weeks plus ipilimumab 1mg/kg IV every 6 weeks. 1 cycle = 6 weeks. Treatment will continue until disease progression, unacceptable toxicity, patient request to discontinue or completion of treatment. Subjects may receive up to 25 doses of nivolumab and 8 doses of ipilimumab

Type: Interventional

Start Date: Jul 2018

open study

Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease
Kevin Winthrop Mycobacterium Avium Complex Nontuberculous Mycobacterium Infection
NTM therapy consists of a multi-drug macrolide based regimen for 18-24 months. Treated patients frequently experience debilitating side effects, and many patients delay the start of antibiotic treatment due to these risks. Common side effects include nausea, diarrhea, and fatigue,... expand

NTM therapy consists of a multi-drug macrolide based regimen for 18-24 months. Treated patients frequently experience debilitating side effects, and many patients delay the start of antibiotic treatment due to these risks. Common side effects include nausea, diarrhea, and fatigue, and rare but serious toxicities include ocular toxicity, hearing loss, and hematologic toxicity. To date, most of the evidence underlying the current treatment recommendations has come from observational studies in which either a macrolide has been combined with rifampin and ethambutol, or in some cases combined with ethambutol alone. The proposed study will answer whether a third drug is necessary or whether taking two drugs can increase tolerability without a substantial loss of efficacy.

Type: Interventional

Start Date: Feb 2019

open study

A Study to Evaluate the Safety and the Efficacy of EscharEx (EX-02 Formulation) in Debridement of Venous...
MediWound Ltd Venous Leg Ulcer
This study is a multicenter, prospective, randomized, placebo controlled, adaptive design study performed to assess the safety and the efficacy of 5% EscharEx (EX-02) compared to Gel Vehicle (placebo) and non-surgical standard of care (NSSOC), in debridement of Venous Leg Ulcers... expand

This study is a multicenter, prospective, randomized, placebo controlled, adaptive design study performed to assess the safety and the efficacy of 5% EscharEx (EX-02) compared to Gel Vehicle (placebo) and non-surgical standard of care (NSSOC), in debridement of Venous Leg Ulcers (VLU) (in a ratio of 1:1:1) in debridement of VLU. The main objective of this study is: To assess the safety and the efficacy of EscharEx (EX-02 formulation) compared to Gel Vehicle (placebo) and non-surgical standard of care (NSSOC), in debridement of Venous Leg Ulcers (VLU) 174 randomized adult patients with VLU that fail to heal for 4-52 weeks, and with >50% non-viable tissue (necrotic/slough/fibrin) on the VLU. The maximum number of patients to be enrolled is 225. The total duration of the study of each participating subject is up to 17 weeks: screening (1 week) + Daily visit period (up to 2 weeks) + Twice-weekly visits period (2 weeks) + Weekly visits period (10 weeks) + closure confirmation (up to 2 weeks, if applicable). Each patient will go through 4 periods during the trial: 1. Screening period (2 visits, 7 [+2] days apart). Including: recording demographics, medical history and concomitant medications, vital signs, physical examination, clinical laboratory tests, wound photography and assessments and questionnaires (pain, wound status and QoL). During this period, wounds will be treated by standard treatment (e.g. appropriate dressing, compression bandage) per investigator discretion, with the exclusion of mechanical and surgical debridement. During the screening period, patients whose wound size size (surface area, as measured by eKare inSightTM) decreases by more than 20 percent will be excluded. 2. Daily visits period (up to 8 daily site visits within up to 14 days): Eligible patients will be randomized into one of the study arms: EX-02, or Gel Vehicle (Placebo), or NSSOC in a 1:1:1 ratio. Patients will be treated with up to 8 daily 24±3 hours applications or until complete debridement is achieved, whichever occurs first. On the weekends between treatments of EX-02 or Gel material, the wound will be dressed with a compatible dressing, and by compression therapy. Patients treated with NSSOC continue using NSSOC during the weekend according to label or instructions for use, and compression therapy. 3. Twice-weekly visits period (4 visits within 14 days): the patients will be followed twice weekly for two weeks, (4 visits within 14 days). During each visit, safety parameters will be recorded (AEs, concomitant medications, pain, vital signs), the wound will be washed, photographed and assessed for wound size (by eKare inSightTM), % of nonviable tissue (by clinical assessment), and wound healing status (assessed clinically). The investigator will clinically assess complete debridement, upon achieving a viable wound bed after removal of all non-viable tissue, suitable for initiation of the wound healing stage. 4. Weekly visits period (10 visits in 10 weeks): patients will be followed once weekly for 10 weeks, (10 visits within 10 weeks). During each weekly visit, safety parameters will be recorded (AEs, concomitant medications, pain, vital signs), the wound will be washed, photographed and assessed for wound size (by eKare inSightTM), % of nonviable tissue (by clinical assessment), and wound healing status (assessed clinically). The investigator will clinically assess complete debridement, upon achieving a viable wound bed after removal of all non-viable tissue, suitable for initiation of the wound healing stage. Complete wound closure defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits, 2 weeks apart will be assessed clinically. Thus, if closure occurs close to the end of weekly visit period, i.e. on 9th or 10th visit of the weekly period, an additional confirmation visit will be performed 2 weeks later.

Type: Interventional

Start Date: Dec 2019

open study

Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies
Georgetown University Solid Tumor, Adult Homologous Recombination Deficiency
This is a multi-institutional Phase I dose-escalation and dose-expansion trial for patients with advanced, solid tumor malignancies who have pre-identified deleterious germline or somatic mutations in the homologous recombination deoxyribonucleic acid (DNA) repair pathway (HR... expand

This is a multi-institutional Phase I dose-escalation and dose-expansion trial for patients with advanced, solid tumor malignancies who have pre-identified deleterious germline or somatic mutations in the homologous recombination deoxyribonucleic acid (DNA) repair pathway (HR deficient). The trial is designed to assess the efficacy and safety of niraparib plus carboplatin in patients with evidence of HRD. The primary endpoint will be identifying the recommended phase 2 dose (RP2D) and schedule of niraparib plus carboplatin, as well as establishing the anti-tumor efficacy of niraparib plus carboplatin as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

Type: Interventional

Start Date: Oct 2017

open study

Nilotinib in Huntington's Disease
Georgetown University Huntington Disease
Based on strong pre-clinical evidence of the effects of Nilotinib on neurodegenerative pathologies, including autophagic clearance of neurotoxic proteins, neurotransmitters (dopamine and glutamate), immunity and behavior, the investigators conducted an open label pilot clinical... expand

Based on strong pre-clinical evidence of the effects of Nilotinib on neurodegenerative pathologies, including autophagic clearance of neurotoxic proteins, neurotransmitters (dopamine and glutamate), immunity and behavior, the investigators conducted an open label pilot clinical trial in mid-to-advanced PD with dementia (PDD) and Dementia with Lewy Bodies (DLB) (stage 3-4) patients. Participants (N=12) were randomized 1:1 to once daily oral dose of 150mg and 300mg Nilotinib for 6 months. The investigators data suggests that Nilotinib penetrates the brain and inhibits CSF Abelson (Abl) activity via reduction of phosphorylated Abl in agreement with pre-clinical data. Several studies suggest that CSF alpha-Synuclein and Abeta42 are decreased and CSF total Tau and p-Tau are increased in PD and DLB. The investigators data shows attenuation of loss of CSF alpha-Synuclein and Abeta40/42 with 300mg (50% of the CML dose) compared to 150mg Nilotinib after 6 months treatment. CSF homovanillic acid (HVA), which is a by-product of dopamine metabolism, is significantly increased; and CSF total Tau and p-Tau are significantly reduced (N=5, P<0.05) with 300mg Nilotinib between baseline and 6 months treatment. Despite the reduction of L-Dopa replacement therapies in our study, the Unified Parkinson's Disease Rating Scale (UDPRS) I-IV scores improved with 150mg (3.5 points) and 300mg (11 points) from baseline to 6 months and worsened (13.7 points and 11.4 points) after 3 months withdrawal of 150mg and 300mg, respectively. Other non-motor functions e.g. constipation was resolved in all patients and cognition was also improved (3.5 points) using both the Mini-Mental Status Exam (MMSE) or the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-Cog) between baseline and 6 months. MMSE scores returned to baseline after 3 months of Nilotinib withdrawal. These data are very compelling to evaluate the effects of Nilotinib in an open label proof-of-concept study in patients with HD.

Type: Interventional

Start Date: Nov 2018

open study

Peer Support for Exercise in Older Veterans With Psychotic Disorders
VA Office of Research and Development Psychotic Disorder
Older adults with psychotic disorders experience a dual set of challenges: those related to serious mental illness, and those related to aging. They have medical, cognitive, psychological and social difficulties; as a result they have an almost four times greater likelihood of... expand

Older adults with psychotic disorders experience a dual set of challenges: those related to serious mental illness, and those related to aging. They have medical, cognitive, psychological and social difficulties; as a result they have an almost four times greater likelihood of early institutionalization in nursing homes. These challenges make it difficult for this group to engage in health behaviors, such as exercise. This is unfortunate, since participation in health-promoting activities is essential for maintaining functional independence with age. This study aims to develop and pilot test a peer coaching intervention for older Veterans with psychotic disorders, in which VA Peer Specialists, who are Veterans in recovery from mental illness, will provide intensive coaching to older Veterans with psychotic disorders to promote their participation in exercise and physical activity. Results from this study will inform us as to whether this intervention is acceptable to Veterans, feasible to implement, and effective in increasing exercise, physical activity, and physical fitness/function.

Type: Interventional

Start Date: Jun 2018

open study

177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate...
Weill Medical College of Cornell University Prostate Cancer
The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591 in combination with ketoconazole and hydrocortisone against prostate cancer. expand

The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591 in combination with ketoconazole and hydrocortisone against prostate cancer.

Type: Interventional

Start Date: Jun 2009

open study

A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients With...
United Therapeutics Pulmonary Hypertension Chronic Obstructive Pulmonary Disease
This is a multicenter, randomized, double-blind, placebo-controlled, 30-week, adaptive cross-over study, with a Treatment Period of approximately 26 weeks under the Original Design or, if applicable, a 17-week parallel study, with a Treatment Period of approximately 14 weeks... expand

This is a multicenter, randomized, double-blind, placebo-controlled, 30-week, adaptive cross-over study, with a Treatment Period of approximately 26 weeks under the Original Design or, if applicable, a 17-week parallel study, with a Treatment Period of approximately 14 weeks under the Contingent Design.

Type: Interventional

Start Date: Jun 2018

open study

A Crossover Pilot Study of the Effect of Amiloride on Proteinuria
Georgetown University Proteinuria
This cross-over study is designed to test the hypothesis that amiloride will reduce urinary protein excretion and protect the kidney from rapid progression in proteinuric kidney disease. expand

This cross-over study is designed to test the hypothesis that amiloride will reduce urinary protein excretion and protect the kidney from rapid progression in proteinuric kidney disease.

Type: Interventional

Start Date: Jul 2013

open study

Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or...
National Cancer Institute (NCI) Lung Adenocarcinoma Lung Large Cell Carcinoma Resectable Lung Non-Small Cell Carcinoma Stage IB Lung Non-Small Cell Carcinoma AJCC v7 Stage IB Lung Squamous Cell Carcinoma AJCC v7
This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain... expand

This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

Type: Interventional

Start Date: Aug 2014

open study

Identification of the Pre-exposure Prophylaxis (PrEP) Cascade for Women.
Medstar Health Research Institute Pre-Exposure Prophylaxis
Pre-exposure prophylaxis (PrEP) is a daily pill that greatly reduces the risk of transmission of human immunodeficiency virus (HIV), however the barriers to PrEP use for women are understudied and PrEP is underutilized by women. Partnering with the DC Department of Health and... expand

Pre-exposure prophylaxis (PrEP) is a daily pill that greatly reduces the risk of transmission of human immunodeficiency virus (HIV), however the barriers to PrEP use for women are understudied and PrEP is underutilized by women. Partnering with the DC Department of Health and the DC Center for AIDS Research (DC-CFAR), the overarching goals are (1) to identify and populate the PrEP cascade for women, (2) to provide a blueprint for family planning providers to integrate HIV prevention into their practices and target evidence-based interventions to the women at highest risk for HIV in their communities, and (3) to evaluate the cost-effectiveness of this intervention. The overarching hypotheses are that (1) the timeline and roadmap to PrEP adoption and the PrEP cascade will be different for cis-gender women than that described for men who have sex with men (MSM) and transgender women, (2) women seeking family planning services will be eligible for and interested in PrEP and family planning providers are ideally situated to provide this care, and (3) provision of PrEP in the family planning setting will be cost-effective. This research proposes to evaluate (1) PrEP cascade of events for women (eligibility for PrEP, acceptability/interest in PrEP, access/linkage to a PrEP program, initiation of PrEP, retention, and adherence to PrEP) and (2) the integration of universal screening for PrEP and PrEP provision into a women's family planning clinic. This research will allow for targeted evidence-based interventions to reach women at high-risk for HIV and will provide a blueprint for the implementation of PrEP services in the family planning setting nationally.

Type: Observational

Start Date: Jul 2018

open study

Family Genetics Health Education and Healthy Behaviors
National Human Genome Research Institute (NHGRI) Diabetes Cancer Heart Disease
Background: - Family-based approaches to reduce disease risk and promote healthy behaviors may be better than targeting individuals. Risk assessments based on family health history may help educate families on disease risks and encourage them to change physical activity and... expand

Background: - Family-based approaches to reduce disease risk and promote healthy behaviors may be better than targeting individuals. Risk assessments based on family health history may help educate families on disease risks and encourage them to change physical activity and food choices. Specifically, researchers want to better understand the role of mothers in teaching healthy behaviors to their families. Objectives: - To determine mothers influence on diet and health-related behaviors. - To study an intervention tool that connects family health history and disease risk. Eligibility: - 18 years of age who have at least one child living at home. Design: - Participants will complete a survey over the phone. The survey will take 30 to 40 minutes to complete. The survey will collect family health history on heart disease, diabetes, colorectal cancer, and breast cancer. - Researchers will give participants a Family Health Package (FHP). The FHP will provide information on family health history and disease risk. It will also recommend behaviors that can reduce health risks. - Two weeks after sending the FHP, participants will complete a phone survey about the FHP materials and their social networks. - Some participants will be invited to focus groups. The focus groups will explore diet and health behavior. They will look at food purchasing and preparation and meal sharing. The groups will also discuss attitudes toward healthy eating and physical activity. Each focus group will last 1 to 2 hours. - Participants will be asked to complete an electronic survey regarding participants health status, causal health beliefs, risk perceptions, and intentions to communicate health information. - Then, participants will have the opportunity to use the electronic version of the FHP, which will assess family health history. - After using the FHeP, participants will complete a short electronic survey to identify knowledge and understanding gained from the use of the application, changes in communication intentions, and suggestions for improvements to the application. - Upon completion of the electronic portion of the study, a study team member will conduct a semi-structured interview to allow the participants to qualitatively evaluate their user experience, including satisfaction and usefulness. - This study process will take approximately 60-90 minutes.

Type: Observational

Start Date: Jan 2012

open study

Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer...
National Cancer Institute (NCI) Bladder Adenocarcinoma Bladder Mixed Adenocarcinoma Bladder Small Cell Carcinoma Bladder Squamous Cell Carcinoma Chromophobe Renal Cell Carcinoma
This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that have spread to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the... expand

This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that have spread to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.

Type: Interventional

Start Date: Apr 2019

open study

De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating...
National Cancer Institute (NCI) Basaloid Squamous Cell Carcinoma Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Oropharyngeal Squamous Cell Carcinoma Papillary Squamous Cell Carcinoma
This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer that is early in its growth and may not have spread to other parts of the... expand

This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer that is early in its growth and may not have spread to other parts of the body (early-stage), and is not associated with smoking. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see if a reduced dose of radiation therapy and nivolumab works as well as standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.

Type: Interventional

Start Date: Jul 2019

open study

Testing Maintenance Immunotherapy Versus Observation in Patients With Oropharynx Cancer
National Cancer Institute (NCI) Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
This phase II/III trials studies whether maintenance immunotherapy (nivolumab) following definitive treatment with radiation and chemotherapy (cisplatin) result in significant improvement in overall survival (time being alive) and progression-free survival (time being alive without... expand

This phase II/III trials studies whether maintenance immunotherapy (nivolumab) following definitive treatment with radiation and chemotherapy (cisplatin) result in significant improvement in overall survival (time being alive) and progression-free survival (time being alive without cancer) for patients with intermediate risk human papillomavirus (HPV) positive oropharynx cancer that has spread to nearby tissue or lymph nodes. Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether chemotherapy and radiation therapy followed by maintenance nivolumab therapy works better than chemotherapy and radiation therapy alone in treating patients with HPV positive oropharyngeal cancer.

Type: Interventional

Start Date: Jun 2019

open study

Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by...
National Cancer Institute (NCI) Metastatic Melanoma Recurrent Melanoma Stage III Cutaneous Melanoma AJCC v7 Stage IIIA Cutaneous Melanoma AJCC v7 Stage IIIB Cutaneous Melanoma AJCC v7
This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage... expand

This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as BRAFV600 and cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.

Type: Interventional

Start Date: Jul 2015

open study