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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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 94 months; from study start november 10, 2015 to september 15, 2023

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 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

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.

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