Active — Not RecruitingPhase 1/2

A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer

United States, Czechia, Denmark83 participantsStarted 2025-03-06

Plain-language 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 can participate

Age range

0 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Melanoma
. Hodgkin Lymphoma
. High and Low Grade Glioma: including Glioblastoma multiforme (GBM), Diffuse intrinsic pontine glioma (DIPG), and ependymoma.
. Osteosarcoma
. Hepatic tumors \[including Hepatoblastoma, Hepatocellular carcinoma (HCC), and Fibrolamellar carcinoma\]
. Rhabdomyosarcoma
. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is in Phase 1/2 and is no longer recruiting — does that mean all the treatment slots are filled, and is there any chance of being considered if a spot opens up or a related study begins?
2Since Part 1 of this trial is specifically measuring dose-limiting toxicities and adverse events, including immune-related side effects, how do those kinds of immune-mediated reactions typically look in kids and young adults, and how would they be managed if they occurred?
3My child's diagnosis is one of several very different cancer types included in this study — does the combination of cobolimab and dostarlimab have any particular evidence or rationale for working in our specific cancer type, compared to the others on the list?
4Because this is an early-phase trial still figuring out the right dose, would a more established standard treatment be a safer or more effective first step for us right now, and what would we lose or gain by waiting to see results from this trial before deciding?
5The trial is measuring cardiac parameters and lab changes as safety signals — given my child's current health, are there any pre-existing conditions or medications that might make those risks more of a concern for us specifically?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1- Number of participants with Dose Limiting Toxicities (DLTs)

Timeframe: 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

Timeframe: Up to approximately 46 months

Part 1- Serum concentration of Cobolimab

Timeframe: 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

Timeframe: 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

Timeframe: Up to approximately 12 months

Part 2- Confirmed Objective Response Rate (ORR)

Timeframe: Up to approximately 46 months

Trial details

NCT IDNCT06521567

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-13

View on ClinicalTrials.gov More Melanoma trials

Plain-language summary

Who can participate

Age range

0 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Melanoma
. Hodgkin Lymphoma
. High and Low Grade Glioma: including Glioblastoma multiforme (GBM), Diffuse intrinsic pontine glioma (DIPG), and ependymoma.
. Osteosarcoma
. Hepatic tumors \[including Hepatoblastoma, Hepatocellular carcinoma (HCC), and Fibrolamellar carcinoma\]
. Rhabdomyosarcoma
. 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)

What they're measuring

Part 1- Number of participants with Dose Limiting Toxicities (DLTs)

Timeframe: Up to 42 days

Timeframe: Up to approximately 46 months

Part 1- Serum concentration of Cobolimab

Timeframe: 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

Timeframe: 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

Timeframe: Up to approximately 12 months

Part 2- Confirmed Objective Response Rate (ORR)

Timeframe: Up to approximately 46 months