Solid Tumors
Conditions
Brief summary
Occurrence of treatment-related non-serious treatment-emergent adverse events (TEAEs), all serious adverse events (SAEs), immune-related adverse events (irAEs), and infusion-related reactions according to the version of National Cancer Institute Common Technology Criteria for Adverse Events (NCI-CTCAE) used in the respective parent study.
Detailed description
Overall Survival, from baseline in parent study to date of death due to any cause., Progression Free Survival according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by Investigator, from baseline in parent study until progressive disease (PD) or death due to any cause., Duration Response assessed from complete response (CR) or partial response (PR) until PD or death due to any cause.
Interventions
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of treatment-related non-serious treatment-emergent adverse events (TEAEs), all serious adverse events (SAEs), immune-related adverse events (irAEs), and infusion-related reactions according to the version of National Cancer Institute Common Technology Criteria for Adverse Events (NCI-CTCAE) used in the respective parent study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, from baseline in parent study to date of death due to any cause., Progression Free Survival according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by Investigator, from baseline in parent study until progressive disease (PD) or death due to any cause., Duration Response assessed from complete response (CR) or partial response (PR) until PD or death due to any cause. | — |
Countries
Bulgaria, France, Hungary, Italy, Poland, Romania, Spain
Outcome results
None listed