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Monoclonal Antibodies

Part 2- Dose expansion for Melanoma

Phase 1 & 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Participants between the age of 0 to not more than 21 years at the time of signing informed consent form (ICF).
1. Melanoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 73 months
Awards & highlights

Summary

The goal of this interventional study is to determine the strength of cobolimab and dostarlimab that is most tolerated in children and young adults who have advanced solid tumors. This study also aims: (a) to check if it is safe to use cobolimab and dostarlimab combination in children and young adults, (b) to see how to manage the side effects that may occur, and (c) the effect of this treatment in participants

Who is the study for?
This trial is for young people with advanced solid tumors, including melanoma. It's looking to find the best dose of two drugs, Cobolimab and Dostarlimab, that children and young adults can tolerate.
What is being tested?
The study tests the combination of Cobolimab and Dostarlimab in pediatric and young adult patients. The aim is to determine a safe dosage level, manage side effects effectively, and assess how well these treatments work against cancer.
What are the potential side effects?
Possible side effects from Cobolimab and Dostarlimab may include immune system reactions affecting organs, infusion-related symptoms like fever or chills, fatigue, skin reactions, nausea or diarrhea.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 73 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 73 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1- Number of participants with Dose Limiting Toxicities (DLTs)
Part 1- Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), immune-mediated adverse events (imAEs) and adverse events (AEs) leading to discontinuation occurring during the study
Part 1- Recommended Phase 2 Dose (RP2D) of Cobolimab and Dostarlimab combination
+5 more
Secondary study objectives
Part 1 and 2: Duration of response (DOR)
Part 1 and 2: Number of participants with positive results in Anti-drug antibody (ADA) test against Cobolimab
Part 1 and 2: Number of participants with positive results in Anti-drug antibody (ADA) test against Dostarlimab
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2- Dose expansionExperimental Treatment2 Interventions
Group II: Part 1- Dose determinationExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dostarlimab
2020
Completed Phase 3
~1760
Cobolimab
2016
Completed Phase 3
~1590

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Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,784 Previous Clinical Trials
8,123,872 Total Patients Enrolled
39 Trials studying Melanoma
19,728 Patients Enrolled for Melanoma
~87 spots leftby Jul 2028
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