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Monoclonal Antibodies

Cobolimab + Dostarlimab for Cancer

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)
Participants with Melanoma who have not received prior systemic therapy
Must not have
Participant has uncontrolled CNS involvement by any tumor pathology
Has received systemic steroid therapy within 3 days prior to the first dose of the study treatment or is receiving any other form of immunosuppressive medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 73 months
Awards & highlights

Summary

This trial aims to find out the safe and tolerable dose of cobolimab and dostarlimab in children and young adults with advanced solid tumors. It also looks at the side effects and

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
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I am 21 years old or younger and can sign the consent form.
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I have melanoma and haven't had any systemic therapy.
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My cancer has a BRAF mutation and I qualify for specific targeted therapy and immunotherapy.
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My brain metastases have been treated and are under control without spread to the spinal fluid.
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I can care for myself and do most daily activities.
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My Hodgkin lymphoma has not improved after two treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to my brain and is not under control.
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I have taken steroids or immunosuppressive medications within the last 3 days.
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I have a serious heart condition.
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I have a long-term lung condition.

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 2- Confirmed Objective Response Rate (ORR)
Secondary study objectives
Part 1 and 2: Duration of response (DOR)
Part 1 and 2: Overall Survival (OS)
Part 1 and 2: Progression Free Survival (PFS)
+2 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

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,788 Previous Clinical Trials
8,176,676 Total Patients Enrolled
39 Trials studying Melanoma
19,728 Patients Enrolled for Melanoma
~87 spots leftby Jul 2028
Unbiased ResultsWe believe in providing patients with all the options.
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