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)
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
• 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)
∙ 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