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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival
Secondary outcome measures
Clinical response
Immune response
Incidence of toxicities
+1 more

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
~11670
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750
Sargramostim
2008
Completed Phase 4
~850

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,663 Previous Clinical Trials
40,925,305 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Frank S HodiPrincipal InvestigatorECOG-ACRIN Cancer Research Group
3 Previous Clinical Trials
492 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the most well-known applications for Nivolumab?

"Nivolumab is most often given to patients with cancer, but it can also be used to help people undergoing allogenic bone marrow transplantation therapy, those with unresectable melanoma, and squamous cell carcinoma."

Answered by AI

How many study participants are receiving care in this trial?

"This clinical trial needs 600 willing and eligible participants. Those who fit the inclusion criteria can enroll at Cancer and Blood Specialists-Henderson in Henderson, Nevada or IHA Hematology Oncology Consultants-Canton in Canton, Michigan."

Answered by AI

What is the data telling us about Nivolumab's effectiveness?

"Nivolumab was first studied in 2001 at the Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium. As of now, there have been 508 completed trials with 832 more currently underway across the globe; many in Henderson, Nevada."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
How old are they?
18 - 65
What site did they apply to?
Cotton O'Neil Cancer Center / Stormont Vail Health
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
2015. "A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02339571.
All > Minnesota > Paid Studies Maine
~313 spots leftby Jun 2033
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