Testing the Combination of Anti-Cancer Drugs Atezolizumab and Tiragolumab in People with Advanced Stage Rare Cancers (RARE3 Trial)
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT05715281
This clinical trial is exploring how well the combination of two immunotherapy drugs, atezolizumab and tiragolumab, works in treating people with advanced rare cancers. The study involves taking small samples of the tumor and blood to understand how these drugs affect the immune system and which patients might benefit the most.
Patient Parameters
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Program Overview
This study is testing a combination of two drugs, atezolizumab and tiragolumab, to see if they can help treat rare solid tumors that have spread to other parts of the body. These drugs are a type of immunotherapy, which means they help the body's immune system fight cancer. The study involves taking small samples of the tumor and blood to learn more about how the drugs work and who might benefit the most from them. The goal is to see if this combination can help shrink tumors in patients with advanced rare cancers.
Description
The main goal of this study is to see how the immune system's CD8+ T cells, which help fight cancer, are activated before and after treatment with atezolizumab and tiragolumab. Researchers will also look at how well the cancer responds to the treatment and how long patients can go without the cancer getting worse. They will explore various markers in the tumor and blood to understand the treatment's effects better.
Participants will receive atezolizumab and tiragolumab through an IV every 21 days, as long as the cancer does not progress or cause unacceptable side effects. The study includes regular scans, blood tests, and biopsies to monitor the treatment's impact.
After finishing the treatment, participants will be followed up for 30 days to check on their health and any side effects.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of rare solid tumors that have not responded to standard treatments or for which no standard treatment exists.
- Not be eligible for other higher priority studies.
- Have measurable disease that can be tracked using standard criteria.
- Be able to provide a tumor sample for biopsy.
- Be 18 years or older.
- Have a performance status that allows for daily activities with some restrictions.
- Have adequate blood cell counts and organ function as determined by specific tests.
- HIV-positive patients must have an undetectable viral load.
- Hepatitis B and C patients must have controlled or cured infections.
- Have treated brain metastases that are stable.
- Be willing to provide biopsy samples for research.
- Agree to use effective contraception during and after the study.
- Understand and agree to sign informed consent.
Exclusion Criteria
- Have had prior monoclonal antibody therapy recently.
- Have not recovered from significant side effects of previous cancer treatments.
- Are receiving other investigational drugs.
- Have had severe allergic reactions to similar drugs.
- Are taking systemic immunosuppressive medications recently.
- Have uncontrolled illnesses that would interfere with the study.
- Are pregnant or breastfeeding.
- Have a history of autoimmune diseases that are not well-controlled.
- Have active tuberculosis or severe infections recently.
- Have had major surgery recently and not fully recovered.
- Have received a live vaccine recently or plan to during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| National Cancer Institute Developmental Therapeutics Clinic | 20892 | Bethesda | Maryland |
| National Institutes of Health Clinical Center | 20892 | Bethesda | Maryland |
| Ohio State University Comprehensive Cancer Center | 43210 | Columbus | Ohio |
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