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Arm C: Nivolumab plus ipilimumab for Melanoma

Q: Are there any available slots for patients to participate in this clinical trial?

<p>As per clinicaltrials.gov, this study is actively seeking participants. The trial was first listed on 1st March 2024 and last modified on 6th March 2024.</p>

Q: What is the current number of individuals who are being enrolled in this medical study?

<p>Affirmative. Information provided on clinicaltrials.gov confirms the ongoing recruitment of participants for this medical trial, which was initially posted on March 1st, 2024 and most recently revised on March 6th, 2024. The study aims to enroll a total of 30 patients at one designated site.</p>

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

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

~2620

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,452 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

Frequently Asked Questions

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

Are there any available slots for patients to participate in this clinical trial?

"As per clinicaltrials.gov, this study is actively seeking participants. The trial was first listed on 1st March 2024 and last modified on 6th March 2024."

Answered by AI

What is the current number of individuals who are being enrolled in this medical study?

"Affirmative. Information provided on clinicaltrials.gov confirms the ongoing recruitment of participants for this medical trial, which was initially posted on March 1st, 2024 and most recently revised on March 6th, 2024. The study aims to enroll a total of 30 patients at one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Biomarker Driven Patient Selection Neoadjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma

2024. "Biomarker Driven Patient Selection Neoadjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06295159.

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