Study on Nivolumab, Ipilimumab, and GM-CSF for Advanced Melanoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02339571

Provider View

This clinical trial is testing the combination of two immunotherapy drugs, nivolumab and ipilimumab, with or without an additional drug called sargramostim, to see how well they work in treating advanced melanoma that cannot be surgically removed.

Patient Parameters

Program Overview

The study aims to find out if combining nivolumab and ipilimumab with sargramostim is more effective than using nivolumab and ipilimumab alone in treating advanced melanoma. These drugs are designed to help the immune system attack cancer cells. Sargramostim may help by increasing white blood cell production. The trial will also look at the side effects of these treatments.

Description

The main goal of this study is to compare the overall survival of patients receiving nivolumab and ipilimumab with sargramostim to those receiving nivolumab and ipilimumab without sargramostim. Secondary goals include evaluating how long patients live without the cancer getting worse, the side effects of the treatments, and how well the immune system responds to the treatments.

The study will also explore the impact of tobacco use on treatment side effects and patient symptoms, as well as quitting behaviors and the use of support for quitting.

Participants will be randomly assigned to one of two groups:

  • Group A: Patients will receive nivolumab and ipilimumab, along with sargramostim, for four cycles. If the cancer responds well, they may continue with nivolumab and sargramostim for up to two years.

  • Group B: Patients will receive nivolumab and ipilimumab for four cycles. If the cancer responds well, they may continue with nivolumab for up to two years.

Throughout the study, patients will have regular scans and blood tests to monitor their health and the cancer's response to treatment. After completing the study treatment, patients will have follow-up visits every three months for two years, then every six months for three more years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have a known BRAF mutation status of the tumor.
  • Must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential.
  • Have advanced melanoma that cannot be surgically removed and is clearly progressing.
  • Have measurable disease according to specific criteria.
  • May have had certain prior treatments if enough time has passed since the last dose.
  • Must not have had certain treatments in the metastatic setting.
  • Must have stopped previous cancer treatments and recovered from side effects.
  • Must not receive other investigational agents or live vaccines during the study.
  • Must not have active brain metastases unless treated and stable.
  • Must not have other current cancers, except for certain non-threatening types.
  • Must meet specific blood count and organ function criteria.
  • Must not have serious or unstable medical conditions or infections.
  • Must not have autoimmune disorders requiring ongoing treatment with systemic steroids.
  • Must not have a history of certain autoimmune diseases or inflammatory bowel disease.
  • Must not have other significant medical, surgical, or psychiatric conditions that could interfere with the study.

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