N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma

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.”

• Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

  Measured over: From beginning of Cycle 1 (each cycle is 28 days) to 30 days after end of treatment study visit.

• Incidence of clinically significant changes in comprehensive metabolic panel (CMP)

  Measured over: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and each subsequent treatment Cycle on Days 1 and Day 15 and at the end of treatment study visit.

• Incidence of clinically significant changes in Hematology blood panel.

  Measured over: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and each subsequent treatment Cycle on Days 1 and Day 15 and at the end of treatment study visit.

• Incidence of clinically significant changes in Urinalysis.

  Measured over: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and each subsequent treatment Cycle on Days 1 and Day 15 and at the end of treatment study visit.

• 12-lead Electrocardiogram (ECG)

  Measured over: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and each subsequent Cycle Day1 through to the end of treatment study visit.

• Incidence of clinically significant changes in Temperature

  Measured over: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and Cycle 2 on days 1, 2 and 15, followed by each subsequent treatment Cycle on Days 1 and 15 and on the end of treatment study visit.

• Incidence of clinically significant changes in Heart Rate

  Measured over: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and Cycle 2 on days 1, 2 and 15, followed by each subsequent treatment Cycle on Days 1 and 15 and on the end of treatment study visit.

• Incidence of clinically significant changes in Respiratory Rate

  Measured over: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and Cycle 2 on days 1, 2 and 15, followed by each subsequent treatment Cycle on Days 1 and 15 and on the end of treatment study visit.

• Incidence of clinically significant changes in Blood Pressure

  Measured over: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and Cycle 2 on days 1, 2 and 15, followed by each subsequent treatment Cycle on Days 1 and 15 and on the end of treatment study visit.

• Incidence of clinically significant changes in Oxygen Saturation

  Measured over: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and Cycle 2 on days 1, 2 and 15, followed by each subsequent treatment Cycle on Days 1 and 15 and on the end of treatment study visit.

• Neurological assessment to grade Immune effector cell-associated neurotoxicity syndrome (ICANS)

  Measured over: On Cycle 1 (each cycle is 28 days) Day1, Day2, Day 15 and Day16, followed by each subsequent treatment Cycle on Days 1 and 15. Collection stops at the end of treatment study visit.

• Safety assessed by Cytokine Levels

  Measured over: From Cycle 1 (each cycle is 28 days) Day1, Day2, Day 15 and Day16, followed by each subsequent treatment Cycle on Day 1. Collection stops at the end of treatment study visit.

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