Immunotherapy + Radiation for Advanced Lung or Liver Cancer

Recruiting in Palo Alto (17 mi)

James W. Welsh | MD Anderson Cancer Center

Overseen byJoe Y Chang, MD,MS,PHD

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 and best dose of anti-glucocorticoid-induced tumor necrosis factor receptor (GITR) agonistic monoclonal antibody BMS-986156 (BMS-986156) when given together with ipilimumab and nivolumab with or without stereotactic body radiation therapy and to see how well they work in treating patients with lung/chest or liver cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as BMS-986156, 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. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. It is not yet known whether giving BMS-986156, ipilimumab, and nivolumab with or without stereotactic body radiation therapy will work better in treating patients with lung/chest or liver cancers.

Eligibility Criteria

This trial is for adults with advanced or metastatic lung/chest or liver cancers. Participants must have completed previous cancer therapies, be in stable condition (ECOG <=2), and have acceptable organ function. Those with certain brain metastases can join if symptom-free without needing high-dose steroids. Pregnant women, individuals with serious autoimmune diseases, uncontrolled illnesses, recent surgeries, active infections like HIV or hepatitis B/C are excluded.

Inclusion Criteria

White blood count (WBC) >= 2500/uL (use of growth factors or blood transfusion to achieve these requirements is not allowed 2 weeks prior to study enrollment)

I've waited the required time after my last cancer treatment to join this study.

My liver function tests are within normal limits without needing treatments to achieve this.

+12 more

Exclusion Criteria

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

I have not had a bad reaction to previous immunotherapy treatments.

I am not pregnant or planning to become pregnant/breastfeed during and after the study. I agree to follow strict birth control measures.

+8 more

Participant Groups

The study tests the combination of immunotherapy drugs BMS-986156, Ipilimumab, Nivolumab and possibly Stereotactic Body Radiation Therapy (SBRT). It aims to find the best dose of BMS-986156 and see how well these treatments work together against lung/chest or liver cancers by enhancing the body's immune response to attack cancer cells.

3Treatment groups

Experimental Treatment

Group I: Group III (nivolumab, BMS-986156, SBRT)Experimental Treatment3 Interventions

Patients receive nivolumab IV over 30 minutes and anti-GITR agonistic monoclonal antibody BMS-986156 over 60 minutes on day 1. Patients also undergo SBRT over 30-45 minutes on days 1-4 for 4 fractions or on days 1-12 for 10 fractions. Treatment repeats every 28 days for up to 26 cycles of nivolumab and for up to 4 cycles of anti-GITR agonistic monoclonal antibody BMS-986156 in the absence of disease progression or unacceptable toxicity.

Group II: Group II (ipilimumab, BMS-986156, SBRT, nivolumab)Experimental Treatment4 Interventions

Patients receive ipilimumab IV over 90 minutes and anti-GITR agonistic monoclonal antibody BMS-986156 IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 2, patients then undergo SBRT on days 29-32 for 4 fractions or on days 29-40 for 10 fractions. Beginning day 1 of cycle 5 (day 85), patents receive nivolumab IV over 30 minutes. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.

Group III: Group I (ipilimumab, BMS-986156, nivolumab)Experimental Treatment3 Interventions

Patients receive ipilimumab IV over 90 minutes and anti-GITR agonistic monoclonal antibody BMS-986156 IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning day 1 of cycle 5 (day 85), patients receive nivolumab IV over 30 minutes. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.