A Phase 1/2 interventional study of Cobolimab and Dostarlimab in Melanoma, Hodgkin Lymphoma and High and Low Grade Glioma, sponsored by GlaxoSmithKline. Active, not recruiting at 20 sites in 6 countries. Open to participants aged 0 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-11-12.
Sponsored by GlaxoSmithKline · Phase 1/2, Interventional, and Treatment
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
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 83 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants are eligible to be included in the study only if all of the following criteria apply:
Part 1: Participants with advanced or metastatic solid tumors who have had disease progression after treatment with available therapies that are known to confer clinical benefit and who have limited available treatment options as determined by the investigator. Additionally, exposure to prior immunotherapy or experimental therapies is acceptable:
Part 2:
Participants with Melanoma who have not received prior systemic therapy:
Relapsed/refractory Hodgkin lymphoma (HL) that has failed at least 2 prior lines of systemic therapy)
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Medical conditions:
Prior/ Concomitant therapy:
Prior/Concurrent clinical study experience
Drug: Cobolimab · Drug: Dostarlimab
Drug: Cobolimab · Drug: Dostarlimab
Cobolimab will be administered
Dostarlimab will be administered
Part 1- Number of participants with Dose Limiting Toxicities (DLTs)
Time frame: Up to 42 days
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
Time frame: Up to approximately 46 months
Part 1- Serum concentration of Cobolimab
Time frame: 1±0.5 hours (h) post-dose on Cycle 1 Day 1; 168±12 h post-dose Cycle 1Day 8; Pre-dose and 1±0.5 h post-dose on Cycle 2 Day 1; Cycle 4 Day 1 and Cycle 6 Day 1(Each cycle is of 21 days)
Part 1- Serum concentration of Dostarlimab
Time frame: 1±0.5 h post start of cobolimab infusion on Cycle 1 Day 1; Pre-dose on Cycle 2 Day 1; Cycle 4 Day 1 and Cycle 6 Day 1(Each cycle is of 21 days)
Part 1- Recommended Phase 2 Dose (RP2D) of Cobolimab and Dostarlimab combination
Time frame: Up to approximately 12 months
Part 2- Confirmed Objective Response Rate (ORR)
Confirmed ORR is defined as the proportion of participants who have achieved confirmed complete response (CR) or confirmed partial response (PR), evaluated using disease-specific tumor assessment criteria based on Investigator assessment
Time frame: Up to approximately 46 months
Part 2- Number of participants with TEAEs, SAEs, imAEs, TEAEs leading to death and AEs leading to discontinuation
Time frame: Up to approximately 46 months
Part 2-Number of participants with changes in laboratory parameters, vital signs and cardiac parameters
Time frame: Up to approximately 46 months
Part 1 and 2: Receptor occupancy (RO)
RO will be measured in whole blood and presented as normalized ratio \[Fluorescence Minus One (FMO) subtracted values of free T cell immunoglobulin and mucin domain containing protein 3 (TIM-3) to total TIM-3\]
Time frame: Pre-dose Cycle 1 Day 1, 5 h post-start of cobolimab administration Cycle 1 Day 1, anytime Cycle 1 Day 8, pre-dose Cycle 2 Day 1, and pre-dose Cycle 4 Day 1 (Each cycle is of 21 days)
Part 1- Confirmed ORR
Confirmed ORR is defined as the proportion of participants who have achieved confirmed CR or confirmed PR, evaluated using disease specific tumor assessment criteria based on Investigator assessment
Time frame: Up to approximately 70 months
Part 1 and 2: Progression Free Survival (PFS)
PFS is defined as the length of time until disease progression, from the date of first dose to the earliest date of assessment of disease progression based on disease-specific tumor assessment criteria by Investigator assessment, or death by any cause, whichever occurs first
Time frame: Up to approximately 70 months
Part 1 and 2: Duration of response (DOR)
DOR is defined as the time from first documented response (CR/PR) until the time of first documentation of disease progression based on disease-specific tumor assessment criteria by Investigator assessment, or death, whichever occurs first
Time frame: Up to approximately 70 months
Part 1 and 2: Overall Survival (OS)
OS is defined as the time from the date of first dose to the date of death by any cause
Time frame: Up to approximately 70 months
Part 1 and 2: Number of participants with positive results in Anti-drug antibody (ADA) test against Cobolimab
Time frame: Pre-dose on Cycle 1 Day 1; Cycle 2 Day 1; Cycle 4 Day 1 and Cycle 6 Day 1[Each cycle is of 21 days]; 30-Day and 90-Day safety follow up (FUP) Visit
Part 1 and 2: Number of participants with positive results in Anti-drug antibody (ADA) test against Dostarlimab
Time frame: Pre-dose on Cycle 1 Day 1; Cycle 2 Day 1; Cycle 4 Day 1 and Cycle 6 Day 1[Each cycle is of 21 days]; 30-Day and 90-Day safety follow up (FUP) Visit
Part 1 and 2: Titers of ADA to Cobolimab
Time frame: Pre-dose on Cycle 1 Day 1; Cycle 2 Day 1; Cycle 4 Day 1 and Cycle 6 Day 1[Each cycle is of 21 days]; 30-Day and 90-Day safety follow up (FUP) Visit
Part 1 and 2: Titers of ADA to Dostarlimab
Time frame: Pre-dose on Cycle 1 Day 1; Cycle 2 Day 1; Cycle 4 Day 1 and Cycle 6 Day 1[Each cycle is of 21 days]; 30-Day and 90-Day safety follow up (FUP) Visit
Part 2- Serum concentration of Cobolimab
Time frame: 1±0.5 hours(h) post-dose on Cycle1Day 1;168±12h post-dose Cycle1Day8; Pre-dose & 1±0.5h post-dose on Cycle2Day1; Cycle4Day1 & Cycle6Day1[Each cycle is of 21 days];End of Treatment(EOT; EOT is within 7days of last dose), 30Day safety follow up(FUP) Visit
Part 2- Serum concentration of Dostarlimab
Time frame: 1±0.5 h post start of cobolimab infusion on Cycle 1 Day 1; Pre-dose on Cycle 2 Day 1; Cycle 4 Day 1 and Cycle 6 Day 1 [Each cycle is of 21 days]; End of Treatment (EOT; EOT is within 7 days of last dose), 30-Day safety follow up (FUP) Visit
Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting information: Study protocol, Sap, Icf, Csr
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This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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