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A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma

Testing new treatments for advanced melanoma with Nivolumab, Ipilimumab, and GM-CSF.

Recruiting
18 years and older
All
Phase 2/3

This study is testing how well two cancer drugs, **nivolumab** and **ipilimumab**, work with or without another drug called **sargramostim** in treating advanced melanoma, a type of skin cancer. Melanoma is "advanced" when it spreads or can't be removed by surgery. The drugs being tested are **immunotherapy** drugs, which help the immune system fight cancer. **Sargramostim** is a colony-stimulating factor that boosts white blood cell production to help fight infections.

Key Points:

  • This study lasts up to 2 years with treatment cycles every 3 weeks for 4 cycles and follow-ups every 3 to 6 months after treatment.
  • Participants must have stage III-IV melanoma and meet specific health criteria. They should not have certain other medical conditions or have used certain medications recently.
  • Eligible participants must not be pregnant or breastfeeding, and they need to use effective birth control methods during the study.

Participants will receive treatments through IV and injections and undergo tests like MRI and CT scans. The study will compare the survival and side effects of using nivolumab and ipilimumab with and without sargramostim.

Study details
    Stage III Cutaneous Melanoma AJCC v7
    Stage IV Cutaneous Melanoma AJCC v6 and v7

NCT02339571

National Cancer Institute (NCI)

17 May 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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