DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors
Study of Immunotherapy in Treating Rare Tumors
Brief description of study.
This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors.
Detailed description of study
The purpose of this study is to evaluate the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Bronchioloalveolar Carcinoma,Adrenal Cortex Carcinoma,Adrenal Gland Pheochromocytoma,Acinar Cell Carcinoma
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:
- Patients must have histologically confirmed rare cancer and/or cancer of unknown primary, that did not have a match to a molecularly-guided therapy on EAY131 "National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH)" protocol or who progressed on molecularly-matched therapy and have no further molecularly-matched treatment recommendations per EAY131, "NCI-MATCH"
- Patients that are determined to have a rare cancer with unknown primary site are eligible provided that there is histologic documentation of metastatic malignancy with no discernible primary site identified from histopathologic review, physical exam and associated cross-sectional imaging of the chest, abdomen, and pelvis
For a full list of participation criteria, please visit clinicaltrials.gov.
This study investigates the use of immunotherapy in treating patients with rare tumors. The purpose of this study is to evaluate how well the treatment works in patients with advanced rare cancers. Immunotherapy is a type of cancer treatment that helps the immune system fight cancer. In this study, patients will receive a combination of two investigational medications that are designed to boost the immune response against cancer cells.
Participants in this study will undergo certain procedures to monitor their health and the effects of the treatment. These procedures may include regular medical check-ups, blood tests, and imaging studies to assess the response of the tumors to the treatment. The study aims to gather information on the effectiveness and safety of the combination immunotherapy for rare tumors.
- Who can participate: Patients with confirmed rare cancer or cancer of unknown primary, who do not have a match to a molecularly-guided therapy, or have progressed on such therapy, are eligible. There must be histologic evidence of metastatic malignancy with no identifiable primary site.
- Study details: Participants will receive a combination of investigational medications designed to enhance the immune system's ability to fight cancer. A placebo, which is an inactive substance, is not used in this study. Participants will not be paid for their participation.