Immunotherapy + Radiation for Advanced Lung or Liver Cancer

Overseen By Joe Chang

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Autoimmune diseases, Active infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 55

Duration: Up to 1 year

51 Participants Needed

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.

Research Team

Joe Y Chang, MD,MS,PHD

Principal Investigator

M.D. Anderson Cancer Center

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive ipilimumab and BMS-986156 with or without SBRT, followed by nivolumab in later cycles

Up to 1 year

Every 21 days for 4 cycles, then every 28 days for up to 26 cycles

Radiation

Patients undergo stereotactic body radiation therapy (SBRT) targeting 1-4 lesions

4-10 days

4 fractions over 4 days or 10 fractions over 10-12 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

Follow-up at 30 days, then every 2-4 months

Treatment Details

Interventions

• BMS-986156
• Ipilimumab
• Nivolumab
• Stereotactic Body Radiation Therapy

Trial Overview 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.

Participant Groups

Group I: Group III (nivolumab, BMS-986156, SBRT) Experimental Treatment 3 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 Treatment 4 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 Treatment 3 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+