Active — Not RecruitingPhase 1/2

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

United States83 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 range0 Years – 21 Years

SexALL

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

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

Part 2- Number of participants with TEAEs, SAEs, imAEs, TEAEs leading to death and AEs leading to discontinuation

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 range0 Years – 21 Years

SexALL

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

Part 2- Number of participants with TEAEs, SAEs, imAEs, TEAEs leading to death and AEs leading to discontinuation