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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 up to 10 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 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 (OS)
PD-L1 status
Relapse-free survival (RFS)
Secondary outcome measures
BRAF mutation status
Change in quality of life
Incidence of toxicity
+2 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
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 2
~1730
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Positron Emission Tomography
2008
Completed Phase 2
~2240
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,931,780 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your ANC (a type of white blood cell) count must be at least 1,500 microliters within 42 days before enrolling in the trial.Your total bilirubin level must be within a certain range, unless you have Gilbert's syndrome, in which case it can be slightly higher.Your liver enzymes (SGOT and SGPT) should not be more than twice the upper limit of normal.Your platelet count is at least 100,000 per microliter within the last 42 days.You have HIV, but you can still join the study if you meet certain requirements within 30 days before signing up.Your alkaline phosphatase level is not more than twice the upper limit of normal.You need to have a blood test for lactate dehydrogenase (LDH) within 42 days before joining the study.I am not planning to take any treatments not allowed in the study.My recent tests show no signs of cancer.My kidney function, measured by creatinine levels or clearance, is normal.I have never needed steroids for lung inflammation.I do not have an active hepatitis B or C infection.I have taken a pregnancy test in the last 28 days and it was negative.I agree to use effective birth control during and for 4 months after the study.I can complete questionnaires in English, Spanish, or French.My melanoma was surgically removed and it started in the skin or the origin is unknown.I am seeking treatment for melanoma at its initial stage or after its first spread.My melanoma was completely removed with no signs of remaining cancer.I have had a complete lymph node removal due to cancer in the nodes.I had all my lymph nodes removed and any returned cancer has been surgically removed.I have not received any form of immunotherapy.I do not have an infection that needs treatment with medication.I can provide at least five slides of my cancer for testing.You need to have had a normal or not concerning electrocardiogram (ECG) within 42 days before joining the study.Your hemoglobin level is at least 10 grams per deciliter within the 42 days before joining the study.My melanoma is at an advanced stage (IIIA, IIIB, IIIC, or IV).I have not received any live vaccines in the last 42 days.I haven't needed treatment for an autoimmune disease in the last 2 years.I have not had initial treatment for my melanoma.My skin cancer is not at the T1b N1a stage without an ulcer.I had surgery to remove my melanoma with wide margins.I have had radiation therapy before or after surgery.I have not had any other cancer types before.Any side effects from my past surgery or radiation have mostly gone away.I am not planning to undergo any other treatments after step 2 registration.I can carry out all my usual activities without help.My melanoma is not from the skin but from mucosal or other internal areas.I have never had cancer spread to my brain.My cancer has spread to multiple lymph node areas.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (pembrolizumab)
- Group 2: Arm I (high-dose recombinant interferon alfa-2B, ipilimumab)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Pembrolizumab gone through the necessary channels for government approval?
"Pembrolizumab has received a score of 3 for safety due to the amount of Phase 3 trial data that suggests both its efficacy and safety."
Answered by AI
How many research facilities are investigating this treatment?
"Patients are being recruited from across the country, with notable enrolment locations including Kaiser Permanente Northwest in Portland, Oregon, Altru Cancer Center in Grand Forks, North dakota, and Blanchard Valley Hospital in Findlay, Texas."
Answered by AI
What sort of goals does this experiment hope to achieve?
"The objective of this clinical trial is to evaluate the Overall survival (OS) of patients over the course of 5 years. Secondary outcomes that will be assessed include Change in quality of life, Incidence of toxicity, and Long-term survival. Longitudinal regression models will be used to evaluate changes in quality of life over time, while exponential-logistic cure regression models will be used to examine the long-term survival of patients."
Answered by AI
What are the typical Pembrolizumab patients that you have seen in your experience?
"Pembrolizumab is often used in the treatment of malignant neoplasms. This medication can also help patients with unresectable melanoma, microsatellite instability high, and hepatitis c virus (hcv) infection."
Answered by AI
What are some of the most significant findings from other Pembrolizumab research?
"Pembrolizumab was first studied in 1998 at the Nova Scotia Cancer Centre. Since then, there have been 737 completed clinical trials. There are 1332 active studies currently recruiting patients, a number of which are based in Portland, Oregon."
Answered by AI
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