Checkpoint Inhibitor
Nivolumab for Cutaneous 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
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
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.
Eligible Conditions
- Cutaneous Melanoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have advanced melanoma that cannot be removed by surgery and it has been confirmed by medical tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
~11670
Biospecimen Collection
2004
Completed Phase 1
~1470
Computed Tomography
2017
Completed Phase 2
~2890
Ipilimumab
FDA approved
Nivolumab
FDA approved
Sargramostim
FDA approved
Find a site
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,412 Previous Clinical Trials
41,238,466 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Frank S HodiPrincipal Investigator
ECOG-ACRIN Cancer Research Group3 Previous Clinical Trials
491 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