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

NCT06521567 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2194512024-511350-41-00
• Study Type: interventional
• Target: 83
• Locations: 6 countries
• Sites: 20

Brief 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

Conditions

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

Keywords

Solid Tumours; Cobolimab; Dostarlimab

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (11)

• Part 1 and 2: Receptor occupancy (RO)

  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

  Up to approximately 70 months

• Part 1 and 2: Progression Free Survival (PFS)

  Up to approximately 70 months

• Part 1 and 2: Duration of response (DOR)

  Up to approximately 70 months

• Part 1 and 2: Overall Survival (OS)

  Up to approximately 70 months

Study Arms (2)

Part 1- Dose determination

EXPERIMENTAL

Drug: Cobolimab; Drug: Dostarlimab

Part 2- Dose expansion

EXPERIMENTAL

Drug: Cobolimab; Drug: Dostarlimab

Interventions

Cobolimab DRUG

Cobolimab will be administered

Part 1- Dose determination; Part 2- Dose expansion

Dostarlimab DRUG

Dostarlimab will be administered

Part 1- Dose determination; Part 2- Dose expansion

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Participants between the age of 0 to not more than 21 years at the time of signing informed consent form (ICF).
• Disease characteristics:
• Part 1: Participants with advanced or metastatic solid tumors who have had disease progression after treatment with available therapies that are known to confer clinical benefit and who have limited available treatment options as determined by the investigator. Additionally, exposure to prior immunotherapy or experimental therapies is acceptable:
• 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
• Part 2:
• Participants with Melanoma who have not received prior systemic therapy:
• Participants with BRAF gene, found on chromosome 7 (BRAF) mutations who are eligible for a BRAF-targeted therapy are eligible if they qualify for immunotherapy.
• Participants with locally treated and controlled metastatic central nervous system (CNS) lesions without leptomeningeal spread are eligible
• Relapsed/refractory Hodgkin lymphoma (HL) that has failed at least 2 prior lines of systemic therapy)

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Medical conditions:
• Participant has uncontrolled CNS involvement by any tumor pathology
• Participant 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 branch block.
• Participant has clinically significant cardiovascular disease
• Participant has chronic respiratory disease
• Participant has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
• Participants who have a history of immunodeficiency disease, including other acquired or congenital immunodeficiency diseases, or organ transplantation
• Participants who have received plasma exchange within 7 days before the first dose of study intervention.
• Participant has current active pneumonitis or any history of pneumonitis requiring steroids or immunomodulatory treatment within 90 days of planned enrollment or any history of drug-induced pneumonitis.
• Participant has ongoing adverse reaction(s) from prior therapy that has (have) not recovered to ≤Grade 1 or to the Baseline status preceding prior therapy, excluding \[e.g., alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 neuropathy\], or that the investigator, with the agreement of the sponsor, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study.
• Participant has any active renal condition (e.g., infection, requirement for dialysis, or any other significant renal condition (that could affect the participant's safety).
• Participant has any serious and/or unstable medical or psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant's safety, obtainment of informed consent, or compliance to the study procedures.
• Prior/ Concomitant therapy:
• Has received treatment with an investigational agent or any other anti-cancer therapy within 30 days, or \<5 times the half-life of the most recent therapy prior to signing ICF, whichever is shorter.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (20)

GSK Investigational Site

Los Angeles, California, 90048, United States

Location

GSK Investigational Site

Iowa City, Iowa, 52242, United States

Location

GSK Investigational Site

Hackensack, New Jersey, 07601, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45229, United States

Location

GSK Investigational Site

Providence, Rhode Island, 02903, United States

Location

GSK Investigational Site

Madison, Wisconsin, 53792, United States

Location

GSK Investigational Site

Brno, 61300, Czechia

Location

GSK Investigational Site

Phaha 5, 15006, Czechia

Location

GSK Investigational Site

Copenhagen, 2100, Denmark

Location

GSK Investigational Site

Bordeaux, 33076, France

Location

GSK Investigational Site

Lyon, 69373, France

Location

GSK Investigational Site

Paris, 75248, France

Location

GSK Investigational Site

Strasbourg, 67098, France

Location

GSK Investigational Site

Villejuif, 94805, France

Location

GSK Investigational Site

Bologna, 40138, Italy

Location

GSK Investigational Site

Napoli, 80123, Italy

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Madrid, 28009, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Melanoma; Hodgkin Disease; Glioblastoma; Diffuse Intrinsic Pontine Glioma; Ependymoma; Osteosarcoma; Carcinoma, Hepatocellular; Hepatoblastoma; Fibrolamellar hepatocellular carcinoma; Rhabdomyosarcoma

Interventions

dostarlimab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neoplasms, Glandular and Epithelial; Brain Stem Neoplasms; Infratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma; Adenocarcinoma; Carcinoma; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Complex and Mixed; Myosarcoma; Neoplasms, Muscle Tissue

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: March 6, 2025
• Primary Completion (Estimated): October 13, 2026
• Study Completion (Estimated): October 13, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

US (6); ES (4); DK (1); CZ (2); FR (5); IT (2)