Immunotherapy + Radiation for Advanced Cancer

Recruiting in Palo Alto (17 mi)

James W. Welsh | MD Anderson Cancer Center

Overseen byJames Welsh

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase I/II trial studies the side effects of anti-CTLA4-NF monoclonal antibody (mAb) (BMS986218), nivolumab, and stereotactic body radiation therapy in treating patients with solid malignancies that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as anti-CTLA4-NF mAb (BMS-986218) 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. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving -CTLA4-NF mAb (BMS986218), nivolumab, and stereotactic body radiation therapy may kill more tumor cells.

Eligibility Criteria

Adults with metastatic solid cancers, not breastfeeding or donating sperm, and willing to use contraception. They must have normal organ/marrow function, no severe allergies to immunotherapy drugs, and can't be on certain medications. Eligible even if they've had prior cancer treatments (except anti-CTLA4-NF drugs) or controlled autoimmune disorders.

Inclusion Criteria

I agree to follow the study's contraception rules or abstain from sex as required.

I have brain metastases but no symptoms, and I haven't taken steroids for 2 weeks.

I have had cancer treatment with immunotherapy and my cancer got worse, but it's not required.

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Exclusion Criteria

I am not on treatments like IL-2, interferon, chemotherapy, or high-dose steroids while receiving BMS-986218.

I have hypothyroidism from an autoimmune condition and take hormone replacement.

I do not have any health or mental conditions that could make this study unsafe for me.

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Participant Groups

The trial is testing a combination of an experimental drug BMS986218 with Nivolumab and precise radiation therapy on patients with metastatic cancers. The goal is to see how well this trio works together in stopping cancer growth by enhancing the body's immune response.

2Treatment groups

Experimental Treatment

Group I: Arm II (BMS-986218, SBRT, nivolumab)Experimental Treatment3 Interventions

Patients receive anti-CTLA4 monoclonal antibody BMS-986218 and SBRT as in Arm 1. Beginning cycle 2, patients also receive nivolumab IV over 30 minutes starting on day 1. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (BMS-986218, SBRT)Experimental Treatment2 Interventions

Patients receive anti-CTLA4 monoclonal antibody BMS-986218 IV over 30 minutes on day 1. Treatment repeats every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT on days 36-39 (days 8-11 of cycle 2).