A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer
NCT Number: NCT06521567
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Melanoma
Interventions: DRUG: Cobolimab|DRUG: Dostarlimab
Sponsor: GlaxoSmithKline
Sex: ALL
Age: CHILD, ADULT
Enrollment: 131
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-13
Completion Date: 2030-10-17
Locations: GSK Investigational Site, West Hollywood, California, 90048, United States|GSK Investigational Site, Iowa City, Iowa, 52242-1009, United States|GSK Investigational Site, Boston, Massachusetts, 02115, United States|GSK Investigational Site, Hackensack, New Jersey, 07601, United States|GSK Investigational Site, Cincinnati, Ohio, 45229, United States|GSK Investigational Site, Providence, Rhode Island, 02903, United States|GSK Investigational Site, Madison, Wisconsin, 53792, United States|GSK Investigational Site, Buenos Aires, C1181ACH, Argentina|GSK Investigational Site, Buenos Aires, C1428AQK, Argentina|GSK Investigational Site, Recife, Pernambuco, 50070-550, Brazil|GSK Investigational Site, Jaú, Sao Paulo, 17210-120, Brazil|GSK Investigational Site, São Paulo, Sao Paulo, 08270-070, Brazil|GSK Investigational Site, Barretos, São Paulo, 14784-400, Brazil|GSK Investigational Site, Porto Alegre, 90035-003, Brazil|GSK Investigational Site, Rio de Janeiro, 20230-130, Brazil|GSK Investigational Site, Brno, 61300, Czechia|GSK Investigational Site, Praha 5, 15006, Czechia|GSK Investigational Site, Copenhagen, 2100, Denmark|GSK Investigational Site, Lyon cedex 08, 69373, France|GSK Investigational Site, Marseille, 13005, France|GSK Investigational Site, Paris Cedex 05, 75248, France|GSK Investigational Site, Strasbourg, 67098, France|GSK Investigational Site, Villejuif, 94805, France|GSK Investigational Site, Wuerzburg, Bayern, 97080, Germany|GSK Investigational Site, Berlin, 13353, Germany|GSK Investigational Site, Hamburg, 20246, Germany|GSK Investigational Site, Bologna, Emilia-Romagna, 40138, Italy|GSK Investigational Site, Roma, Lazio, 00165, Italy|GSK Investigational Site, Torino, Piemonte, 10126, Italy|GSK Investigational Site, Napoli, 80123, Italy|GSK Investigational Site, Goyang-si, Gyeonggi-do, 10408, Korea, Republic of|GSK Investigational Site, Seoul, 03080, Korea, Republic of|GSK Investigational Site, Seoul, 03722, Korea, Republic of|GSK Investigational Site, Seoul, 06351, Korea, Republic of|GSK Investigational Site, Seoul, 138-736, Korea, Republic of|GSK Investigational Site, Barcelona, 08035, Spain|GSK Investigational Site, Madrid, 28009, Spain|GSK Investigational Site, Madrid, 28046, Spain|GSK Investigational Site, Valencia, 46026, Spain

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

Primary Outcome Measures: Part 1- Number of participants with Dose Limiting Toxicities (DLTs), 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, Up to approximately 46 months|Part 1- Serum concentration of Cobolimab, 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, 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, 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, Up to approximately 46 months|Part 2- Number of participants with TEAEs, SAEs, imAEs, TEAEs leading to death and AEs leading to discontinuation, Up to approximately 46 months|Part 2-Number of participants with changes in laboratory parameters, vital signs and cardiac parameters, Up to approximately 46 months
Secondary Outcome Measures: Part 1 and 2: Receptor occupancy (RO), RO will be measured in whole blood and presented as normalized ratio \[Fluorescence Minus One (FMO) subtracted values of free T cell immunoglobulin and mucin domain containing protein 3 (TIM-3) to total TIM-3\], 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, Up to approximately 73 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, Up to approximately 73 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, Up to approximately 73 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, Up to approximately 73 months|Part 1 and 2: Number of participants with positive results in Anti-drug antibody (ADA) test against Cobolimab, 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, 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, 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, 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, 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, 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