Study on Nivolumab and Radiation Therapy With or Without Ipilimumab for Treating Brain Metastases from Non-small Cell Lung Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02696993

Provider View

This clinical trial is exploring the safety and effectiveness of combining the drugs nivolumab and ipilimumab with radiation therapy to treat non-small cell lung cancer that has spread to the brain. The study aims to find the best dose and see how well these treatments work together.

Patient Parameters

Program Overview

This study is testing a combination of treatments for non-small cell lung cancer (NSCLC) that has spread to the brain. It involves using two drugs, nivolumab and ipilimumab, which are monoclonal antibodies that may help stop cancer cells from growing. These drugs are used alongside radiation therapy, which targets the brain tumors. The study will determine the safest and most effective doses of these drugs when used with two types of radiation: stereotactic radiosurgery (SRS) and whole brain radiotherapy (WBRT).

Description

The study is divided into two phases. Phase I focuses on finding the best dose of nivolumab and ipilimumab when combined with radiation therapy. Phase II will evaluate how well these treatments work in controlling brain tumors and preventing them from growing.

Participants will be divided into four groups:

  • Group A: Receives nivolumab every two weeks and undergoes stereotactic radiosurgery (SRS) the day after receiving nivolumab.
  • Group B: Receives nivolumab every two weeks and undergoes whole brain radiotherapy (WBRT) daily for 10 days.
  • Group C: Receives nivolumab every two weeks and ipilimumab every six weeks, with SRS the day after nivolumab.
  • Group D: Receives nivolumab every two weeks and ipilimumab every six weeks, with WBRT daily for 10 days.

After completing the treatment, participants will have follow-up visits at 30 days and then every 12 weeks for up to a year to monitor their health and the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-small cell lung cancer that has spread to the brain.
  • Have at least one brain tumor that is 0.3 cm or larger and can be treated with radiation.
  • Able to provide written consent to participate in the study.
  • Have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
  • Meet specific blood count and organ function requirements based on recent tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 31 weeks after the last dose.
  • Men must agree to use contraception during the study and for 31 weeks after the last dose.
  • Previous radiation to other areas is allowed if it does not overlap with the new treatment area, or if a 4-month gap is observed.
  • Previous brain radiation is allowed if it does not exceed safe levels.

Exclusion Criteria

  • Currently participating in another clinical trial or have used an investigational drug or device recently.
  • Have severe autoimmune diseases or require systemic steroids or immunosuppressive drugs.
  • Have had a monoclonal antibody treatment recently and have not recovered from side effects.
  • Have received certain cancer therapies recently and have not recovered from side effects.
  • Have another active cancer that requires treatment, except for certain skin cancers or in situ cervical cancer.
  • Have active infections requiring treatment or hospital admission.
  • Have a history of severe allergic reactions to similar drugs.
  • Are pregnant or breastfeeding, or planning to conceive during the study period.
  • Have certain viral infections like HIV or active hepatitis B or C.
  • Have received a live vaccine recently.
  • Have experienced severe side effects from previous radiation or immunotherapy.
  • Are taking high doses of steroids or have needed them recently.
  • Have specific genetic mutations with available targeted therapies, unless those therapies have failed or were not tolerated.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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