ACTIVE_NOT_RECRUITING

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

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 Solid Tumours Cobolimab Dostarlimab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Phase 1/2 Dose Determination and Dose Expansion Study of Cobolimab in Combination With Dostarlimab in Pediatric and Young Adult Participants With Newly Diagnosed and Relapsed/Refractory Tumors (POPSTAR)

Quick Facts

Study Start:2025-03-06

Study Completion:2032-01-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06521567

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Participants between the age of 0 to not more than 21 years at the time of signing informed consent form (ICF). * Disease characteristics: 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 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	* 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. * 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. * 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.

Inclusion Criteria

Exclusion Criteria

* Participants between the age of 0 to not more than 21 years at the time of signing informed consent form (ICF).
* Disease characteristics:
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
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

* 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.
* 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.
* 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.

Contacts and Locations

Principal Investigator

GSK Clinical Trials

STUDY_DIRECTOR

GlaxoSmithKline

Study Locations (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

Collaborators and Investigators

Sponsor: GlaxoSmithKline

GSK Clinical Trials, STUDY_DIRECTOR, GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-06

Study Completion Date2032-01-02

Study Record Updates

Study Start Date2025-03-06

Study Completion Date2032-01-02

Terms related to this study

Keywords Provided by Researchers

Solid Tumours
Cobolimab
Dostarlimab

Additional Relevant MeSH Terms

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