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Checkpoint Inhibitor

Relatlimab for Melanoma

Phase 1

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

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 at 24 weeks and at 1 year

Awards & highlights

Study Summary

This trial is designed to study the safety and effectiveness of a new drug, relatlimab, when used in combination with another drug, ipilimumab, to treat melanoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 24 weeks and at 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 24 weeks and at 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 weeks and at 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of Participants With Adverse Events Including Dose Limiting Toxicity

Number of Participants with AEs resulting in Death

Number of Participants with AEs resulting in Discontinuation

+3 more

Secondary outcome measures

BICR-assessed PFS rates

BICR-assessed median PFS

DOR assessed by investigator using RECIST 1.1

+11 more

Side effects data

From 2023 Phase 1 & 2 trial • 62 Patients • NCT03310619

36%

Nausea

36%

Vomiting

36%

Thrombocytopenia

27%

Fatigue

27%

Leukopenia

27%

Anaemia

27%

Hypokalaemia

18%

Hyperbilirubinaemia

18%

Neutropenia

18%

Insomnia

18%

Nasal discomfort

18%

Rash

18%

Hypomagnesaemia

18%

Musculoskeletal chest pain

Encephalopathy

Respiratory syncytial virus infection

Ileus paralytic

Enterocolitis

Pyrexia

Back pain

Cellulitis

Acute kidney injury

Rash maculo-papular

Abdominal pain

Lymphopenia

Pain

Hypogammaglobulinaemia

Cough

Aspartate aminotransferase increased

Hyponatraemia

Headache

Hypophosphataemia

Dysphonia

Oropharyngeal pain

Hiatus hernia

Arthralgia

Nystagmus

Febrile neutropenia

Bloody discharge

Hypertension

Sepsis

Neurotoxicity

Acute respiratory failure

Chapped lips

Alanine aminotransferase increased

Squamous cell carcinoma of skin

Asthenia

Pneumonia

Blood alkaline phosphatase increased

Hypocalcaemia

Muscular weakness

Rhinorrhoea

Abdominal pain upper

Upper respiratory tract infection

Hypertriglyceridaemia

Productive cough

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)

Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)

Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)

Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)

Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)

Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)

Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)

Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Part 1: Dose Escalation PhaseExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2014

Completed Phase 3

~2620

Relatlimab

2018

Completed Phase 2

~1110

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,128,503 Total Patients Enrolled

177 Trials studying Melanoma

57,532 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.

What is the total number of people that are allowed to enroll in this clinical trial?

"Unfortunately, this particular study is not currently looking for more participants. The clinical trial was posted on December 9th, 2021 and was last edited on October 20th, 2022. However, if you are interested in other studies, there are 783 trials related to melanoma and 351 trials testing Relatlimab that are actively recruiting patients right now."

Answered by AI

Are participants being recruited for this research project at this time?

"As of now, this particular trial is no longer recruiting patients. The trial's first posting was on December 9th 2021 and the most recent edit was on October 20th 2022. There are 783 other trials concerning melanoma and 351 for Relatlimab that are actively enrolling participants if you're interested in participating in a clinical study."

Answered by AI

What are some of the most common issues that Relatlimab has been shown to be effective in treating?

"Relatlimab is an effective treatment for cutaneous melanoma, but can also help patients that have undergone complete resection, liver carcinoma, and metastatic melanoma."

Answered by AI

What is the research history of Relatlimab?

"Relatlimab is being investigated in 351 clinical trials, 40 of which are Phase 3. The global distribution of these studies spans 23518 locations, with a notable concentration in Pittsburgh, Pennsylvania."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess Safety of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment

2021. "A Study to Assess Safety of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03978611.