A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition

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.”

• Main Study: Objective Response Rate (ORR)

  Measured over: Cycle 1 Day 1 (Each Cycle is 28 days) until objective disease progression or the last evaluable assessment in the absence of progression, or data cut-off (1 year 8 months)

• Biopsy Study: Change From Baseline in CD8+ T-cells Tumour Infiltration-area in the Center Tumor Region

  Measured over: Baseline, On-treatment (Cycle 0 Day 7), and Off-treatment (Cycle 0 Day 15-28) (each cycle is 28 days)

• Biopsy Study: Change From Baseline in CD8+ T-cells Tumour Infiltration-area in the Invasive Margin Region

  Measured over: Baseline, Off-treatment (Cycle 0 Day 15-28) (each cycle is 28 days)

• Biopsy Study: Change From Baseline in CD8+ T-cells Tumour Infiltration-density in the Center Tumor Region

  Measured over: Baseline, On-treatment (Cycle 0 Day 7), and Off-treatment (Cycle 0 Day 15-28) (each cycle is 28 days)

• Biopsy Study: Change From Baseline in CD8+ T-cells Tumour Infiltration-density in the Invasive Margin Region

  Measured over: Baseline, and Off-treatment (Cycle 0 Day 15-28) (each cycle is 28 days)

Changes Tremor has spotted