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Checkpoint Inhibitor

Nivolumab + Ipilimumab + Sargramostim for Advanced Melanoma

Phase 2 & 3

Recruiting

Led By Frank S Hodi

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have unresectable stage III or stage IV melanoma according to American Joint Committee on Cancer (AJCC) version (v)7; patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive

Patients must have discontinued chemotherapy, immunotherapy or other investigational agents used in the adjuvant setting >= 4 weeks prior to randomization and recovered from adverse events due to those agents; mitomycin and nitrosoureas must have been discontinued at least 6 weeks prior to entering the study; patients must have discontinued radiation therapy >= 2 weeks prior to entering the study and recovered from any adverse events associated with treatment; prior surgery must be >= 4 weeks from randomization and patients must be fully recovered from post-surgical complications

Must not have

Patients must not have any currently active central nervous system (CNS) metastases

Patients must not have had any prior ipilimumab and/or anti-PD-1/PD-L1 agent in the metastatic setting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying nivolumab and ipilimumab to see how well they work with or without sargramostim in treating patients with stage III-IV melanoma that cannot be removed by surgery.

Who is the study for?

Adults with advanced melanoma that can't be surgically removed, who haven't had certain treatments recently or have recovered from them. They must not be pregnant, breastfeeding, or have HIV/HBV/HCV infections. No prior ipilimumab/anti-PD-1/PD-L1 in the metastatic setting and no live vaccines close to trial start. Stable brain metastases treated are okay.

What is being tested?

The trial is testing the effectiveness and side effects of nivolumab and ipilimumab with or without sargramostim in patients with stage III-IV melanoma. It aims to see if these immunotherapies help the immune system fight cancer better alone or combined.

What are the potential side effects?

Possible side effects include inflammation in various organs, fatigue, allergic reactions related to infusion, increased risk of infections due to immune system changes, potential for autoimmune disorders activation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My melanoma is at stage III or IV and cannot be surgically removed.

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I stopped my previous cancer treatments at least 4 weeks ago and have recovered from any side effects.

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I don't have any serious health issues that could affect my safety or participation in the study.

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I have autoimmune thyroid disease or type 1 diabetes and am on replacement therapy.

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I know if my tumor has a BRAF mutation.

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I am 18 years old or older.

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I do not have HIV.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I do not have a history of autoimmune diseases affecting my nerves or brain.

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I have never had inflammatory bowel disease or diverticulitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any active brain metastases.

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I have not received ipilimumab or anti-PD-1/PD-L1 treatments for my metastatic condition.

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I haven't had any live vaccines in the last 30 days and won't get any during or for 4 weeks after the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival

Secondary study objectives

Clinical response

Immune response

Incidence of toxicities

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (nivolumab, ipilimumab)Experimental Treatment7 Interventions

INDUCTION THERAPY: Patients receive nivolumab and ipilimumab as in Arm I. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive nivolumab as in Induction therapy. Patients with PR, SD, or CR at 24 weeks may continue maintenance therapy for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI, CT scan, and blood sample collection throughout the study. Patients may also undergo a MUGA during screening, as well as an ECHO throughout the trial as clinically indicated.

Group II: Arm A (nivolumab, ipilimumab, sargramostim)Experimental Treatment8 Interventions

INDUCTION THERAPY: Patients receive nivolumab IV over 30 minutes on day 1 of each cycle, ipilimumab IV over 30 minutes on day 1 of each cycle, and sargramostim SC on days 1-14 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive nivolumab and sargramostim as in Induction therapy. Patients with PR, SC, or CR at 24 weeks may continue maintenance therapy for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI, CT scan, and blood sample collection throughout the study. Patients may also undergo a MUGA during screening, as well as an ECHO throughout the trial as clinically indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Echocardiography

2013

Completed Phase 4

~11580

Nivolumab

2015

Completed Phase 3

~4010