Advanced Melanoma
Conditions
Brief summary
1. Progression Free Survival
Detailed description
1. Objective Response Rate, 2. Overall Survival, 3. Duration of Response, 4. Mean change from baseline in Health-Related Quality of Life (HRQoL) scores as assessed through use of the two-item Global Health Status (GHS)/HRQoL subscale (Questions 29 and 30) of the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) at specified timepoints, 5. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), 6. Change from baseline in targeted vital signs, 7. Change from baseline in targeted clinical laboratory test results
Interventions
DRUGRO7198457
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Genentech Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective Response Rate, 2. Overall Survival, 3. Duration of Response, 4. Mean change from baseline in Health-Related Quality of Life (HRQoL) scores as assessed through use of the two-item Global Health Status (GHS)/HRQoL subscale (Questions 29 and 30) of the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) at specified timepoints, 5. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), 6. Change from baseline in targeted vital signs, 7. Change from baseline in targeted clinical laboratory test results | — |
Countries
Germany, Spain
Outcome results
None listed