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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 looking at how well two drugs, nivolumab and ipilimumab, work on advanced skin cancer called melanoma. Melanoma is a serious type of skin cancer. These drugs help the immune system fight cancer. A third substance, sargramostim, might be added to see if it helps even more. The study compares using nivolumab and ipilimumab with and without sargramostim to understand which combination works best and is safest. Some patients might get all three, while others get just the first two. They will also look at how smoking affects cancer treatment.

  • The study may last up to 2 years, with follow-up for 5 years.
  • Participants must visit the hospital every 3 weeks initially, then less often.
  • Possible risks include side effects like tiredness or skin rashes.

To join, patients need to have advanced melanoma and meet health requirements like being over 18 and not pregnant. They must also not have other serious diseases or recent cancer treatments. This study helps us learn more about treating melanoma and might help future patients.

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

NCT02339571

National Cancer Institute (NCI)

15 March 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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FAQs

Learn more about clinical trials

What is a clinical trial?

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

Why should I take part in a clinical trial?

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

How long does a clinical trial take place?

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

Do I get compensated for taking part in clinical trials?

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

How safe are clinical trials?

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