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Monoclonal Antibodies

Immunotherapy + Radiation for Advanced Cancer

Phase 1 & 2

Waitlist Available

Led By James Welsh

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All patients must have at least one metastatic or primary lesion within the bone, lung/chest, liver or adrenal located in an anatomical location amenable to radiation treatment with either 50 Gy in 4 fractions, 60 Gy in 10 fractions, or 30 Gy in 5 fx. Patients may not have more then 80% liver displaced with cancer

Patients must have histological confirmation of solid metastatic cancer with at least one metastatic or primary lesion in the bone, adrenal, liver or lung/chest

Must not have

Patients that have previously received or progressed on any anti-CTLA4-NF drug

Vitiligo

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of immunotherapy drugs and radiation to treat patients with metastatic solid malignancies. The goal is to see if this combination can kill more tumor cells with fewer side effects.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include typical reactions from immunotherapies such as fatigue, inflammation in organs, allergic reactions, and possibly complications related to pre-existing conditions like autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a cancer lesion in a place suitable for radiation and less than 80% of my liver is affected by cancer.

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My cancer has spread to my bones, adrenal glands, liver, or lungs.

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I am not pregnant and have taken a test to confirm this if I'm able to have children.

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I am 18 years old or older.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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I am fully active or able to carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with or my condition worsened on an anti-CTLA4-NF drug.

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I have vitiligo.

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I have Type 1 diabetes.

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I have a current diagnosis of diverticulitis or other serious GI conditions.

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I have not had severe, unresolved side effects from previous immuno-oncology drugs.

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I have had a stem cell or organ transplant from another person.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Secondary study objectives

Neoplasms

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790