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Active, not recruitingNCT06521567Updated Nov 12, 2025

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

A Phase 1/2 interventional study of Cobolimab and Dostarlimab in Melanoma, Hodgkin Lymphoma and High and Low Grade Glioma, sponsored by GlaxoSmithKline. Active, not recruiting at 20 sites in 6 countries. Open to participants aged 0 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-11-12.

Sponsored by GlaxoSmithKline · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
83
Allocation
Non-randomized
Ages
0 Years to 21 Years
Sex
All
01

Study 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

02

Conditions studied

  • 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
03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's planned enrollment of 83 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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:

  1. Melanoma
  2. Hodgkin Lymphoma
  3. High and Low Grade Glioma: including Glioblastoma multiforme (GBM), Diffuse intrinsic pontine glioma (DIPG), and ependymoma.
  4. Osteosarcoma
  5. Hepatic tumors [including Hepatoblastoma, Hepatocellular carcinoma (HCC), and Fibrolamellar carcinoma]
  6. Rhabdomyosarcoma

Part 2:

  1. 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
  2. Relapsed/refractory Hodgkin lymphoma (HL) that has failed at least 2 prior lines of 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 a complete blood count at screening obtained without transfusion [platelets or red blood cells (RBC)] or receipt of Colony stimulating factor (CSF), Granulocyte colony stimulating factor (G-CSF), Granulocyte macrophage colony stimulating factor (GMCSF) or rErythropoeitin (rEPO) within 2 weeks prior to screening.
    • Adolescent participants who have entered puberty must consent (be willing) to use of contraceptive measures, or refrain from sexual intercourse, if in line with their usual practice, as well as sperm/egg donation for the duration of treatment

Exclusion criteria

Exclusion Criteria:

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 a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening. Participants with prior history of autoimmune disease must be discussed with the medical monitor. Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone for autoimmune thyroiditis or insulin is not exclusionary)
  • 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.
  • Has received systemic steroid therapy within 3 days prior to the first dose of the study treatment or is receiving any other form of immunosuppressive medication. Replacement therapy is not considered a form of systemic therapy. Use of inhaled corticosteroids, local steroid injection, or steroid eye drops is allowed.
  • Has not met the following waiting/washout periods for X-ray therapy (XRT) including external beam radiation therapy/external beam irradiation including protons:
  • Participant has had major surgery within 28 days prior to the first dose of study treatment or has not adequately recovered from any AEs (Grade ≤1) and/or complications from any major surgery. Surgical implantation of a port catheter is not exclusionary.
  • Prior Bone Marrow Transplant \<60 days of screening.
  • Participant has experienced Grade 3 or higher hypersensitivity to prior monoclonal antibody therapy.

Prior/Concurrent clinical study experience

  • Is currently enrolled or has participated in any other clinical study involving an investigational study or interventional medical research within 21 days or 5 half-lives, whichever is shorter, of an investigational medicinal product before signing ICF Diagnostic assessments
  • Has documented presence of Hepatitis B surface antigen (HbsAg) at Screening or within 3 months prior to first dose of study intervention.
  • Has a positive Hepatitis C virus (HCV) antibody test result at Screening or within 3 months prior to first dose of study intervention.
  • Has a positive HCV Ribonucleic Acid (RNA) test result at Screening or within 3 months prior to first dose of study intervention.
  • Has a known history of Human immunodeficiency virus (HIV) or has a HIV-positive test result at Screening.
  • Is pregnant or breastfeeding.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
83 participants (estimated)

Study arms

  • Experimental
    Part 1- Dose determination

    Drug: Cobolimab · Drug: Dostarlimab

  • Experimental
    Part 2- Dose expansion

    Drug: Cobolimab · Drug: Dostarlimab

Interventions

  • DrugCobolimab

    Cobolimab will be administered

  • DrugDostarlimab

    Dostarlimab will be administered

06

What researchers measure

Primary outcomes

  1. Part 1- Number of participants with Dose Limiting Toxicities (DLTs)

    Time frame: Up to 42 days

  2. 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

    Time frame: Up to approximately 46 months

  3. Part 1- Serum concentration of Cobolimab

    Time frame: 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)

  4. Part 1- Serum concentration of Dostarlimab

    Time frame: 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)

  5. Part 1- Recommended Phase 2 Dose (RP2D) of Cobolimab and Dostarlimab combination

    Time frame: Up to approximately 12 months

  6. 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

    Time frame: Up to approximately 46 months

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

    Time frame: Up to approximately 46 months

  8. Part 2-Number of participants with changes in laboratory parameters, vital signs and cardiac parameters

    Time frame: Up to approximately 46 months

Secondary outcomes

  1. Part 1 and 2: Receptor occupancy (RO)

    RO will be measured in whole blood and presented as normalized ratio \[Fluorescence Minus One (FMO) subtracted values of free T cell immunoglobulin and mucin domain containing protein 3 (TIM-3) to total TIM-3\]

    Time frame: 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)

  2. 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

    Time frame: Up to approximately 70 months

  3. 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

    Time frame: Up to approximately 70 months

  4. 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

    Time frame: Up to approximately 70 months

  5. 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

    Time frame: Up to approximately 70 months

  6. Part 1 and 2: Number of participants with positive results in Anti-drug antibody (ADA) test against Cobolimab

    Time frame: 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

  7. Part 1 and 2: Number of participants with positive results in Anti-drug antibody (ADA) test against Dostarlimab

    Time frame: 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

  8. Part 1 and 2: Titers of ADA to Cobolimab

    Time frame: 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

  9. Part 1 and 2: Titers of ADA to Dostarlimab

    Time frame: 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

  10. Part 2- Serum concentration of Cobolimab

    Time frame: 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

  11. Part 2- Serum concentration of Dostarlimab

    Time frame: 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

07

Study locations

20 sites
  • GSK Investigational Site
    Los Angeles, California 90048, United States
  • GSK Investigational Site
    Iowa City, Iowa 52242, 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
    Brno, 61300, Czechia
  • GSK Investigational Site
    Phaha 5, 15006, Czechia
  • GSK Investigational Site
    Copenhagen, 2100, Denmark
  • GSK Investigational Site
    Bordeaux, 33076, France
  • GSK Investigational Site
    Lyon, 69373, France
  • GSK Investigational Site
    Paris, 75248, France
  • GSK Investigational Site
    Strasbourg, 67098, France
  • GSK Investigational Site
    Villejuif, 94805, France
  • GSK Investigational Site
    Bologna, 40138, Italy
  • GSK Investigational Site
    Naples, 80123, Italy
  • GSK Investigational Site
    Barcelona, 08035, Spain
  • GSK Investigational Site
    Madrid, 28009, Spain
  • GSK Investigational Site
    Madrid, 28046, Spain
  • GSK Investigational Site
    Valencia, 46026, Spain
08

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06521567
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 26, 2024
Start date
Mar 6, 2025
Primary completion
Oct 13, 2026 (estimated)
Completion
Oct 13, 2026 (estimated)
Last update
Nov 12, 2025

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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