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

Overseen By Jing Li

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Anti PD1, Anti PD-L1

Disqualifiers: Autoimmune disease, Active infection, HIV, others

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 32

Duration: 6-8 weeks

80 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Jing Li

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive nivolumab with stereotactic radiosurgery (SRS) or whole brain radiotherapy (WBRT), with or without ipilimumab, depending on the group assignment.

6-8 weeks

Nivolumab every 2 weeks, ipilimumab every 6 weeks, SRS once, WBRT daily for 10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

Follow-up at 30 days, then every 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ipilimumab
• Nivolumab
• Stereotactic Radiosurgery
• Whole-Brain Radiotherapy

Trial Overview The 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.

How Is the Trial Designed?

Group I: Group D (nivolumab, ipilimumab, WBRT) Experimental Treatment 5 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 Treatment 5 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 Treatment 4 Interventions

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

Group IV: Group A (nivolumab, SRS) Experimental Treatment 4 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:

• Advanced or metastatic gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma
• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Hepatocellular carcinoma
• Esophageal squamous cell carcinoma

Approved in European Union as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Canada as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+