Ipilimumab +/− Interferon Alfa-2b for Advanced Skin Cancer

Recruiting at313 trial locations

Overseen by Ahmad Tarhini

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies how well ipilimumab with or without high-dose recombinant interferon alpha-2b works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, may block tumor growth by targeting certain cells. Recombinant interferon alfa-2b may interfere with the growth of tumor cells. It is not yet known whether ipilimumab is more effective with or without high-dose recombinant interferon alfa-2b in treating melanoma.

Research Team

Ahmad Tarhini

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for adults with stage III-IV melanoma that can't be surgically removed. Eligible participants must not have other current cancers (except certain cases), no brain metastasis, normal organ function tests, and no history of severe autoimmune diseases or conditions requiring systemic steroids. Women who can bear children and men must use effective contraception.

Inclusion Criteria

I haven't received any vaccines for infectious diseases in the last 4 weeks.

Your white blood cell count is at least 3000 per microliter.

My cancer's size and spread were checked within the last month.

Treatment Details

Interventions

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

Trial Overview The study is testing the effectiveness of ipilimumab alone versus in combination with high-dose recombinant interferon alfa-2b in treating advanced melanoma. Ipilimumab is a monoclonal antibody that may block tumor growth by targeting specific cells, while interferon alfa-2b could interfere with tumor cell growth.

Participant Groups

Group I: Arm D (lower dose ipilimumab) Experimental Treatment 2 Interventions

INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses. MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.

Group II: Arm C (lower dose ipilimumab + HDI) Experimental Treatment 3 Interventions

INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks. MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.

Group III: Arm B (higher dose ipilimumab) Experimental Treatment 2 Interventions

INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses. MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.

Group IV: Arm A (higher dose ipilimumab, HDI) Experimental Treatment 3 Interventions

INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks. MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.

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