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Checkpoint Inhibitor

Interferon + Ipilimumab + Pembrolizumab for Melanoma

Phase 3
Waitlist Available
Led By Sapna Patel
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 completely resected melanoma of cutaneous origin or of unknown primary in order to be eligible for this study
Patients with previously diagnosed melanoma must have had all current disease resected with pathologically negative margins and must have no evidence of disease at the primary site or must undergo re-resection of the primary site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomized patients will be followed until death or 94 months (from study start november 10, 2015 to september 15, 2023), whichever occurs first.
Awards & highlights

Summary

This trial is comparing high-dose interferon alfa-2B, ipilimumab, and pembrolizumab to see which is more effective in treating patients with stage III-IV melanoma.

Who is the study for?
This trial is for patients with high-risk stage III-IV melanoma that's been surgically removed but may return or spread. Participants must have proper organ function, no active infections, and not be pregnant. They should agree to contraception use and complete quality of life assessments in English, Spanish or French. Those with autoimmune diseases treated within the last 2 years, live vaccines recently received, HIV positive without meeting specific criteria, hepatitis B/C infection, prior neoadjuvant treatment for melanoma or a history of certain conditions are excluded.
What is being tested?
The study compares three treatments: high-dose recombinant interferon alfa-2B (which might shrink/slow tumor growth), ipilimumab and pembrolizumab (both monoclonal antibodies that could help the immune system fight cancer). It aims to determine which is more effective post-surgery in preventing melanoma recurrence.
What are the potential side effects?
Possible side effects include flu-like symptoms from interferon alfa-2B; fatigue, diarrhea, skin rash from ipilimumab; and fatigue, coughing and itching from pembrolizumab. Side effects can vary based on individual reactions to the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My melanoma was surgically removed and it started in the skin or the origin is unknown.
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My melanoma was completely removed with no signs of remaining cancer.
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I have had a complete lymph node removal due to cancer in the nodes.
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I have not received any form of immunotherapy.
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I am not planning to take any treatments not allowed in the study.
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I have never needed steroids for lung inflammation.
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I do not have an active hepatitis B or C infection.
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I do not have an infection that needs treatment with medication.
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My melanoma is at an advanced stage (IIIA, IIIB, IIIC, or IV).
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I haven't needed treatment for an autoimmune disease in the last 2 years.
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I have not had initial treatment for my melanoma.
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My skin cancer is not at the T1b N1a stage without an ulcer.
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Any side effects from my past surgery or radiation have mostly gone away.
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I am not planning to undergo any other treatments after step 2 registration.
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I can carry out all my usual activities without help.
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My melanoma is not from the skin but from mucosal or other internal areas.
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I have never had cancer spread to my brain.
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My cancer has spread to multiple lymph node areas.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~94 months; from study start november 10, 2015 to september 15, 2023
This trial's timeline: 3 weeks for screening, Varies for treatment, and 94 months; from study start november 10, 2015 to september 15, 2023 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 (OS)
Secondary study objectives
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Overall Survival (OS) in Participants Who Are PD-L1 Positive
Relapse-free Survival (RFS)
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (pembrolizumab)Experimental Treatment5 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan, MRI and blood sample collection throughout the study.
Group II: Arm I (high-dose recombinant interferon alfa-2B, ipilimumab)Active Control7 Interventions
INDUCTION THERAPY: Patients receive high-dose recombinant interferon alfa-2B intravenously (IV) over 20 minutes on days 1-5. Treatment repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity. Or patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 3 weeks for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive high-dose recombinant interferon alfa-2B subcutaneously (SC) on days 1, 3, and 5. Treatment repeats every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity. Or patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for 3 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan, MRI and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Positron Emission Tomography
2011
Completed Phase 2
~2200
Pembrolizumab
2017
Completed Phase 2
~2070

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,001,699 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Sapna PatelPrincipal InvestigatorSWOG Cancer Research Network
3 Previous Clinical Trials
122 Total Patients Enrolled
Kenneth F GrossmannPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02506153 — Phase 3
Cutaneous Melanoma Research Study Groups: Arm II (pembrolizumab), Arm I (high-dose recombinant interferon alfa-2B, ipilimumab)
Cutaneous Melanoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT02506153 — Phase 3
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02506153 — Phase 3
~132 spots leftby Sep 2025
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