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Checkpoint Inhibitor

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

Phase 2

Waitlist Available

Led By Ahmad Tarhini

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

No more than one prior systemic therapeutic regimen for unresectable stage III or stage IV melanoma; this includes chemotherapy, biologic therapy, biochemotherapy, or investigational treatment; this does not include any therapies given in the adjuvant setting; however, patients are excluded if they have a history of prior treatment for melanoma (either adjuvant or metastatic disease) with ipilimumab or other cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor, or prior interferon-alpha treatment for metastatic disease (history of adjuvant interferon-alpha is allowed); there should be a 4-week washout period between last treatment administration and initiation of study therapy

Patients must have unresectable stage III or stage IV melanoma, either initial presentation or recurrent, that is of cutaneous origin or unknown primary origin and that is histologically diagnosed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if ipilimumab, with or without interferon alpha-2b, is effective in treating patients with stage III-IV melanoma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Ipilimumab might cause immune-related side effects such as inflammation of organs, skin rash, diarrhea, and fatigue. Interferon alfa-2b can lead to flu-like symptoms, tiredness, decreased appetite, weight loss and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had only one treatment for advanced melanoma and have not been treated with ipilimumab or CTLA-4 inhibitors.

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My melanoma cannot be surgically removed and is either stage III or IV.

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I am fully active or can carry out light work.

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I have never had inflammatory bowel disease or diverticulitis.

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I have had basal or squamous skin cancer before.

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I don't have active brain cancer, confirmed by recent scans.

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I do not have HIV, hepatitis B, or hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival (PFS)

Secondary study objectives

Overall Survival

Overall Survival (OS)

Progression-free Survival

Other study objectives

Clinical Response Rate

Immune-related Response Rate Per Immune-related Response Criteria

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm D (lower dose ipilimumab)Experimental Treatment2 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 Treatment3 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 Treatment2 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 Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Recombinant Interferon Alfa-2b

2019

Completed Phase 2

~150

Ipilimumab

2015

Completed Phase 3

~3420