Ipilimumab vs Interferon Alfa-2b for Skin Cancer

Recruiting at1054 trial locations

Overseen by Ahmad Tarhini

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known whether ipilimumab is more effective than interferon alfa-2b in treating patients with melanoma.

Research Team

Ahmad Tarhini

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for patients with high-risk stage III-IV melanoma that's been surgically removed. Eligible participants must have certain blood test results, no history of specific medical conditions, and not be on treatments that could affect the trial. They can't have other cancers, active infections like HIV or hepatitis B/C, autoimmune disorders needing steroids, or vaccinations within 4 weeks prior to joining. Women who can become pregnant and men must use contraception.

Inclusion Criteria

I do not have any other types of cancer.

My breast cancer has spread to nearby lymph nodes but not to distant parts of my body.

I don't have health conditions that would make cancer treatment risky.

Exclusion Criteria

I have autoimmune thyroid disease or type 1 diabetes and am on replacement therapy.

I have stage IV melanoma with specific eligibility conditions.

You cannot have certain autoimmune diseases or conditions.

Treatment Details

Interventions

• Ipilimumab (Checkpoint Inhibitor)
• Recombinant Interferon Alfa-2b (Interferon)

Trial Overview The study compares ipilimumab (an immunotherapy drug) with high-dose interferon alfa-2b (a treatment slowing cancer growth) in melanoma patients post-surgery. It aims to determine which is more effective at preventing cancer recurrence by either boosting the immune system or inhibiting tumor cell growth.

Participant Groups

Group I: Arm F (ages 12-17, low-dose ipilimumab) Experimental Treatment 1 Intervention

Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity. (ages 12-17)

Group II: Arm E (ages 12-17, recombinant interferon alfa-2b) Experimental Treatment 1 Intervention

Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity. (ages 12-17)

Group III: Arm D (age 12-17, high-dose ipilimumab) Experimental Treatment 1 Intervention

Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity.

Group IV: Arm C (age >= 18, low-dose ipilimumab) Experimental Treatment 2 Interventions

Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cyclees in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity. (adult accrual has completed to Arms A, B, and C as of 8/15/2014)

Group V: Arm B (age >= 18, recombinant interferon alfa-2b) Experimental Treatment 2 Interventions

Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity. (adult accrual has completed to Arms A, B, and C as of 8/15/2014)

Group VI: Arm A (age >= 18, high-dose ipilimumab) Experimental Treatment 2 Interventions

Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity. (closed accrual as of 4/4/14) (adult accrual has completed to Arms A, B, and C as of 8/15/2014)

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School