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

StatusActive, Not Recruiting
PhasePhase 1/2
Started2025-03-06
View on ClinicalTrials.gov ↗

Amendment history

2025-11-10
Study Status, Study Design, Contacts/Locations v7
Primary completion date2032-01-02→2026-10-13
Completion date2032-01-02→2026-10-13
Enrollment target95→83
Study sites18→20
2025-08-06
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v6
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2029-10-05→2032-01-02
Study sites13→18
2025-05-08
Study Status, Contacts/Locations v5
Start date2025-03-07→2025-03-06
Study sites11→13
2025-04-11
Study Status, Conditions, Contacts/Locations v4
Study sites10→11
2025-03-20
Study Status, Contacts/Locations v3
Start dateestimated 2025-02-28→confirmed 2025-03-07
Study sites3→10
Show 2 earlier versions
2025-02-26
Study Status, Contacts/Locations v2
Primary completion date2028-08-17→2029-10-05
Completion date2030-11-12→2032-01-02
Start date2024-12-31→2025-02-28
Study sites1→3
2024-12-19
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-07-21→2028-08-17
Completion date2030-10-17→2030-11-12
Start date2024-09-13→2024-12-31
Enrollment target131→95
Study sites39→1
Eligibility criteria+2,166 characters
[...] Participants with locally treated and controlled metastatic central nervous system (CNS) lesions without leptomeningeal spread are eligible Relapsed [...] systemic therapy) Participants must have performance status ≥>=60 percent (%) on the Karnofsky scale for participants >16 years of age and ≥>=60% on the Lansky scale for participants ≤<=16 years of age. Adequate organ function as demonstrated by [...] icipant has a heart rate-corrected QT interval according to QT interval (corrected) (Friderecia's formula) (QTcF) prolongation at screening >470 millisecond (msec) or >480 msec for participants with bundle [...] [...]
Secondary endpointsdetails revised at 4 of 11 entries
2024-07-22
Original filing
GlaxoSmithKline
238 trials monitored
See 18 trials at risk
Liver Cancer
1,505 trials monitored
See 60 trials at risk
Melanoma
1,020 trials monitored
See 45 trials at risk
Sarcoma
947 trials monitored
See 53 trials at risk
and 3 more diseases
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
Trial Details
NCT Number NCT06521567
Lead Sponsor GlaxoSmithKline
Conditions Melanoma, Hodgkin Lymphoma, High and Low Grade Glioma, Glioblastoma Multiforme (GBM), Diffuse Intrinsic Pontine Glioma (DIPG), Ependymoma, Osteosarcoma, Hepatic Tumors +4 more
Enrollment 83 participants
Start Date 2025-03-06
Primary Completion 2026-10-13 (estimated)
Study Completion 2026-10-13 (estimated)
Updated on ClinicalTrials.gov 2025-11-12