Nivolumab + Radiation Therapy +/- Ipilimumab for Brain Metastasis from Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen byJing Li

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

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase I/II trial studies the side effects and best dose of nivolumab when giving together with stereotactic radiosurgery or whole brain radiotherapy with or without ipilimumab and to see how well they work in treating patients with non-small cell lung cancer that has spread to the brain. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Radiation therapy, such as whole-brain radiotherapy, uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab together with stereotactic radiosurgery or whole brain radiotherapy with or without ipilimumab may work better in treating patients with non-small cell lung cancer that has spread to the brain.

Eligibility Criteria

This trial is for adults with non-small cell lung cancer that has spread to the brain. They must have at least one treatable brain lesion, be in good physical condition (ECOG 0 or 1), and meet certain blood and biochemical criteria. Women of childbearing age need a negative pregnancy test and agree to birth control; men must use contraception too. Those who've had prior treatments may qualify under specific conditions.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I am not pregnant and agree to use birth control.

My cancer has spread to my brain, as confirmed by an MRI.

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Exclusion Criteria

I have recently used monoclonal antibodies or anti PD1/PD-L1 therapies.

I have recently undergone chemotherapy or targeted therapy.

I have been diagnosed with a severe active form of scleroderma, lupus, or another similar autoimmune disease.

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Treatment Details

Interventions

Ipilimumab (Checkpoint Inhibitor)
Nivolumab (Checkpoint Inhibitor)
Stereotactic Radiosurgery (Radiation)
Whole-Brain Radiotherapy (Radiation)

Trial OverviewThe study is testing how well patients respond to Nivolumab combined with either stereotactic radiosurgery or whole-brain radiotherapy, with or without Ipilimumab. It aims to find the safest doses while assessing how these therapies affect tumor growth in the brain from lung cancer.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Group D (nivolumab, ipilimumab, WBRT)Experimental Treatment5 Interventions

GROUP D: Patients receive nivolumab as in Group A and ipilimumab as in Group C. Patients undergo WBRT once daily for 10 days.

Group II: Group C (nivolumab, ipilimumab, SRS)Experimental Treatment5 Interventions

Patients receive nivolumab as in Group A and ipilimumab IV over 90 minutes every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo SRS once the day after nivolumab administration.

Group III: Group B (nivolumab, WBRT)Experimental Treatment4 Interventions

Patients then receive nivolumab as in Group A. Patients undergo WBRT once daily for 10 days.

Group IV: Group A (nivolumab, SRS)Experimental Treatment4 Interventions

Patients receive nivolumab IV over 90 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo SRS once the day after nivolumab administration.

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸 Approved in United States as Opdivo for: