Advanced / Metastatic cancers
Conditions
Brief summary
Induction period: The 12-week Progression-Free Rate (PFR) or 52-week PFR for IT, Maintenance period Progression-Free Survival (PFS)
Detailed description
- Induction period The Objective Response Rate (ORR), - Maintenance period Secondary endpoints of the maintenance period will be analyzed on the ITT population. Overall survival (OS) and EORTC QLQ-C30 scores, - Whole study period Progression-Free Survival, - Whole study period: The duration of response, - Whole study period: Safety assessment
Interventions
DRUGLynparza 100 mg film-coated tablets
DRUGIMJUDO 20 mg/ml concentrate for solution for infusion.
DRUGLynparza 150 mg film-coated tablets
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
Sponsors
Centre Leon Berard
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Induction period: The 12-week Progression-Free Rate (PFR) or 52-week PFR for IT, Maintenance period Progression-Free Survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Induction period The Objective Response Rate (ORR), - Maintenance period Secondary endpoints of the maintenance period will be analyzed on the ITT population. Overall survival (OS) and EORTC QLQ-C30 scores, - Whole study period Progression-Free Survival, - Whole study period: The duration of response, - Whole study period: Safety assessment | — |
Countries
France
Outcome results
None listed