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

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

Score over time

What counts as success

The trial's main goal(s), called the “primary outcome.”

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

  Measured over: Up to 42 days

• 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

  Measured over: Up to approximately 46 months

• Part 1- Serum concentration of Cobolimab

  Measured over: 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)

• Part 1- Serum concentration of Dostarlimab

  Measured over: 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)

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

  Measured over: Up to approximately 12 months

• Part 2- Confirmed Objective Response Rate (ORR)

  Measured over: Up to approximately 46 months

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

  Measured over: Up to approximately 46 months

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

  Measured over: Up to approximately 46 months

Changes Tremor has spotted