Durvalumab and Tremelimumab for Pediatric Malignancies

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.”

• Dose-Finding Phase: Maximum Serum Concentration (Cmax) of Durvalumab

  Measured over: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 6, 8, 10 and 12

• Dose-Finding Phase: Minimum Serum Concentration (Cmin) of Durvalumab

  Measured over: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 6, 8, 10 and 12

• Dose-Finding Phase: Area Under the Serum Concentration-Time Curve (AUC) From Zero to 14 (AUC 0-14) of Durvalumab

  Measured over: Pre-infusion and post-infusion on Cycle 1 Day 1 and Cycle 1 Day 8

• Dose-Finding Phase: AUC From Zero to 28 (AUC 0-28) of Durvalumab

  Measured over: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15

• Dose-Finding Phase: Time to Cmax (Tmax) of Durvalumab

  Measured over: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 6, 8, 10 and 12

• Dose-Finding Phase: Apparent Terminal Elimination Half-life Associated With the Terminal Slope of the Semi-logarithmic Concentration Time Curve (t½λz) of Durvalumab

  Measured over: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 6, 8, 10 and 12

• Dose-Finding Phase: Dose-Normalized AUC (0-14) (AUC [0-14]/D) of Durvalumab

  Measured over: Pre-infusion and post-infusion on Cycle 1 Day 1 and Cycle 1 Day 8

• Dose-Finding Phase: Dose-Normalized AUC (0-28) (AUC [0-28]/D) of Durvalumab

  Measured over: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15

• Dose-Finding Phase: Dose-Normalized Cmax (Cmax/D) of Durvalumab

  Measured over: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 6, 8, 10 and 12

• Dose-Finding Phase: Cmax of Tremelimumab

  Measured over: Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5

• Dose-Finding Phase: Cmin of Tremelimumab

  Measured over: Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5

• Dose-Finding Phase: (AUC 0-14) of Tremelimumab

  Measured over: Pre-infusion and post-infusion on Cycle 2 Day 1, and Cycle 2 Day 8

• Dose-Finding Phase: (AUC 0-28) of Tremelimumab

  Measured over: Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, and Cycle 2 Day 15

• Dose-Finding Phase: Tmax of Tremelimumab

  Measured over: Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5

• Dose-Finding Phase: T½λz of Tremelimumab

  Measured over: Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5

• Dose-Finding Phase: AUC (0-14)/D of Tremelimumab

  Measured over: Pre-infusion and post-infusion on Cycle 2 Day 1 and Cycle 2 Day 8

• Dose-Finding Phase: AUC (0-28)/D of Tremelimumab

  Measured over: Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, and Cycle 2 Day 15

• Dose-Finding Phase: Cmax/D of Tremelimumab

  Measured over: Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5

• Dose-Finding Phase: Number of Participants With Adverse Events (AE), Serious AE (SAE), AE Leading to Discontinuation of Durvalumab and Tremelimumab, AE of Special Interest (AESI) or AE of Possible Interest (AEPI) Related to Durvalumab and Tremelimumab

  Measured over: From Day 1 up to 15 months

• Dose-Expansion Phase Only: Objective Response Rate (ORR)

  Measured over: From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)

• Dose-Expansion Phase Only: Duration of Response (DOR)

  Measured over: From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)

• Dose-Expansion Phase Only: Best Objective Response (BOR)

  Measured over: From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)

• Dose-Expansion Phase Only: Disease Control Rate (DCR)

  Measured over: At 16 and 24 Weeks

• Dose-Expansion Phase Only: PFS

  Measured over: From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)

• Dose-Expansion Phase Only: Overall Survival (OS)

  Measured over: From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)

• Dose-Expansion Phase Only: Survival Rate at 12 Months and 24 Months

  Measured over: At 12 and 24 Weeks

Changes Tremor has spotted