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

Part of paid clinical trials in Los Angeles, California.

Sponsor
GlaxoSmithKline
Study ID
NCT06521567
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Diffuse Intrinsic Pontine Glioma (DIPG)
  • Ependymoma
  • Fibrolamellar Carcinoma
  • Glioblastoma Multiforme (GBM)
  • Hepatic Tumors
  • Hepatoblastoma
  • Hepatocellular Carcinoma (HCC)
  • High and Low Grade Glioma
  • Hodgkin Lymphoma
  • Melanoma
  • Osteosarcoma
  • Rhabdomyosarcoma

Eligibility Criteria

Sex
ALL
Age
0 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Cobolimab — DRUG
    Cobolimab will be administered
  • Dostarlimab — DRUG
    Dostarlimab will be administered

Study Details

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

Key Dates

Start date
Mar 6, 2025
Status verified
Nov 2025
Primary completion
Oct 13, 2026
Completion
Oct 13, 2026

Study Design

Enrollment
83 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1- Dose determination
  • Experimental: Part 2- Dose expansion

Primary Outcome Measure

Part 1- Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 42 days ]

Locations (6)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteLos AngelesCalifornia90048-
GSK Investigational SiteIowa CityIowa52242-
GSK Investigational SiteHackensackNew Jersey07601-
GSK Investigational SiteCincinnatiOhio45229-
GSK Investigational SiteProvidenceRhode Island02903-
GSK Investigational SiteMadisonWisconsin53792-

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