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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival (PFS)

Secondary outcome measures

Overall Survival

Overall Survival (OS)

Progression-free Survival

Other outcome measures

Clinical Response Rate

Immune-related Response Rate Per Immune-related Response Criteria

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

Ipilimumab

2014

Completed Phase 3

~2620

Recombinant Interferon Alfa-2b

2019

Completed Phase 2

~150

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,930,283 Total Patients Enrolled

4 Trials studying Cutaneous Melanoma

198 Patients Enrolled for Cutaneous Melanoma

Ahmad TarhiniPrincipal InvestigatorECOG-ACRIN Cancer Research Group

4 Previous Clinical Trials

1,858 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01708941 — Phase 2

Cutaneous Melanoma Research Study Groups: Arm D (lower dose ipilimumab), Arm A (higher dose ipilimumab, HDI), Arm B (higher dose ipilimumab), Arm C (lower dose ipilimumab + HDI)

Cutaneous Melanoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT01708941 — Phase 2

Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01708941 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being monitored in this clinical experiment?

"This medical trial, which was originally listed on January 18th 2013 and last amended on September 23rd 2022, is no longer accepting new participants. However, there are 816 trials actively looking for people with recurrent melanoma and 345 studies that require patients to take Ipilimumab."

Answered by AI

Has Ipilimumab been studied in any other investigations?

"In 1998, Ipilimumab was originally investigated at Marshfield Clinic - Weston Center. Nowadays, there are 945 concluded trials and 345 that are still in progress; a significant proportion of which originate from Newark, Delaware."

Answered by AI

How many venues are conducting this exploration?

"This medical experiment is currently enrolling participants at Christiana Gynecologic Oncology LLC in Newark, Delaware, Rush - Copley Medical Center in Aurora, Illinois, and Christiana Care Health System-Wilmington Hospital in Wilmington. Additionally, there are 100 more sites available to join this trial."

Answered by AI

Could you inform me if this research endeavor is currently open to new participants?

"This trial is currently on hiatus and hasn't sought new participants since September 23, 2022. If you're searching for other studies, 816 clinical trials are actively looking to include patients with recurrent melanoma, while 345 are recruiting those taking Ipilimumab."

Answered by AI

What medical conditions has Ipilimumab demonstrated efficacy in treating?

"Ipilimumab has been demonstrated to be efficacious in the management of anthracycline-based chemotherapy, HIV/AIDS, and cutaneous melanoma."

Answered by AI

Has Ipilimumab been granted regulatory sanction by the FDA?

"Our team at Power has assigned a safety rating of 2 to Ipilimumab, as this is still a Phase 2 trial with no efficacy data yet but some reassuring evidence on the drug's safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery

2013. "Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01708941.

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