GSK, 219451, Ph 1/2, open label, Solid tumors, Cobolimab + Dostarlimab

What is the Purpose of this Study?

Primary Objective: Part 1 - To evaluate the safety and tolerability of cobolimab in combination with dostarlimab in pediatric and young adult participants with advanced solid tumors. - To evaluate the PK profile of cobolimab in combination with dostarlimab in pediatric and young adult participants with advanced solid tumors. - To determine the RP2D of cobolimab in combination with dostarlimab in pediatric and young adult participants with advanced solid tumors Part 2 -To evaluate the anti-tumor activity of cobolimab in combination with dostarlimab in pediatric and young adult participants with melanoma (Cohort A), Hodgkin lymphoma (Cohort B), and selected pathologies (Cohort C+) in pediatric and young adult participants with advanced solid tumors -To evaluate the safety and tolerability of cobolimab in combination with dostarlimab in pediatric and young adult participants with melanoma (Cohort A) Hodgkin lymphoma (Cohort B), and selected pathologies (Cohort C+) in pediatric and young adult participants with advanced solid tumors Secondary Objectives: Part 1 - To evaluate target engagement (pharmacodynamics) of cobolimab in combination with dostarlimab - To evaluate the measures of clinical benefit of cobolimab in combination with dostarlimab - To evaluate Immunogenicity (ADA) of cobolimab and dostarlimab in pediatric and young adult participants with advanced solid tumors Part 2 -To evaluate additional measures of clinical benefit for cobolimab in combination with dostarlimab in pediatric and young adult participants with melanoma, Hodgkin lymphoma, and other selected pathologies -To evaluate the PK profile of cobolimab in combination with dostarlimab -To evaluate pharmacodynamics of cobolimab in combination with dostarlimab -To evaluate Immunogenicity (ADA) of cobolimab and dostarlimab


Eligibility

  • 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:
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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Emilie Douine-Barthelemy

More about this Clinical Trial

What is the full name of this clinical trial?

219451: 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

Study Details
Disease Type/Condition

Brain and Nervous System, Melanoma, Other Hematopoietic, Soft Tissue

Principal Investigator

Mascarenhas, Leo

Co-Investigators

Fataneh Majlessipour, Nicole Baca

Age Group

Both

Phase

I/II

IRB Number

STUDY00003499

ClinicalTrials.gov ID

NCT06521567

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Emilie Douine-Barthelemy

Email
emilie.douine-barthelemy@cshs.org
Study Detail
Disease Type/Condition

Brain and Nervous System, Melanoma, Other Hematopoietic, Soft Tissue

Principal Investigator

Mascarenhas, Leo

Age Group

Both

Phase

I/II

IRB Number

GSK219451

ClinicalTrials.gov ID

NCT06521567

Key Eligibility
ClinicalTrials.gov

Contact
Name

Emilie Douine-Barthelemy

Email
emilie.douine-barthelemy@cshs.org