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Arm C: Nivolumab plus ipilimumab for Melanoma

Phase < 1
Recruiting
Led By Ahmad Tarhini, MD, PhD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial aims to see if giving immunotherapy before surgery based on tumor biomarkers can improve patient outcomes. Immunotherapy uses the body's immune system to treat diseases.

Who is the study for?
This trial is for adults with a specific stage of melanoma, which involves regional lymph nodes or distant metastases that are potentially removable by surgery. Participants must not have had previous systemic therapy for melanoma and should be able to provide informed consent.Check my eligibility
What is being tested?
The study tests if using immunotherapy drugs like Ipilimumab, Nivolumab, or their combination before surgery can improve outcomes in melanoma patients. The treatment choice is based on tumor biomarkers.See study design
What are the potential side effects?
Immunotherapies like Ipilimumab and Nivolumab may cause immune-related reactions affecting various organs, skin rash, fatigue, flu-like symptoms, and potential infusion-related side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathologic Major Response (pMR)
Secondary outcome measures
Complete Pathologic Response Rate (pCR)
Non-Response Pathologic Response Rate (pNR)
Overall Survival (OS)
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C: Nivolumab plus ipilimumabExperimental Treatment2 Interventions
PD-L1 negative patients will be given 3 mg/kg of Nivolumab plus 1 mg/kg of Ipilimumab I.V. each given over 30 minutes (-/+ 10 minutes) every 4 weeks (every cycle) for a total of 2 cycles.
Group II: Arm B: Nivolumab- Relatlimab-rmbwExperimental Treatment1 Intervention
PD-L1 negative patients will be given a combination of Nivolumab 480 mg with Relatlimab 160 mg I.V. over 60 minutes (-/+ 10 minutes) every 4 weeks (every cycle) for a total of 2 cycles.
Group III: Arm A: NivolumabExperimental Treatment1 Intervention
PD-L1 positive patients will be given Nivolumab 480 mg I.V. over 30 minutes (-/+ 10 minutes) every 4 weeks (every cycle) for 2 a total of 2 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2610

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
548 Previous Clinical Trials
135,598 Total Patients Enrolled
43 Trials studying Melanoma
3,188 Patients Enrolled for Melanoma
Ahmad Tarhini, MD, PhDPrincipal InvestigatorMoffitt Cancer Center
6 Previous Clinical Trials
148 Total Patients Enrolled
4 Trials studying Melanoma
78 Patients Enrolled for Melanoma
~20 spots leftby Mar 2027
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