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)

Description
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)

Objective
Part 1
Primary Objectives:
-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

Secondary Objectives:
-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
Primary Objectives:
-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:
-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

Treatment 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

Key Eligibility For full study eligibility see this study's ClinicalTrials.gov record

Applicable Disease Sites
Anal; Any Site; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Lymphoma; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

Participating Institutions
UW Health University Hospital