Recurrent or primary advanced (Stage III or IV) endometrial cancer
Conditions
Brief summary
Primary Endpoints for Part 1: The primary efficacy endpoint of PFS is based on the investigator assessment, which is defined as the time from the date of randomization to the earliest date of radiographic assessment of PD or death by any cause in the absence of PD, whichever occurs first. Tumor response will be evaluated using RECIST v.1.1., Primary Endpoints for Part 1: The primary efficacy endpoint of overall survival is defined as the time from randomization to the date of death by any cause., Primary Endpoint for Part 2: The primary efficacy endpoint of PFS is based on the investigator assessment, which is defined as the time from the date of randomization to the earliest date of radiographic assessment of PD or death by any cause in the absence of PD, whichever occurs first. Tumor response will be evaluated using RECIST v.1.1.
Detailed description
1. OS, defined as the time from randomization to the date of death by any cause (Part 2 only)., 2. PFS based on BICR assessment, defined as the time from randomization to the earliest date of assessment of PD per RECIST v.1.1 or death by any cause in the absence of PD per RECIST v.1.1, whichever occurs first, 3. ORR based on BICR and Investigator assessment, defined as the proportion of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR), 4. DOR based on BICR and Investigator assessment, defined as the time from the first documentation of CR or PR until the time of the first documentation of subsequent PD per RECIST v.1.1 or death by any cause in the absence of PD per RECIST v.1.1, whichever occurs first, 5. DCR based on BICR and Investigator assessment, defined as the proportion of subjects who have achieved a BOR of CR, PR, or stable disease per RECIST v.1.1, 6. PFS2, defined as the time from treatment randomization to the date of assessment of progression on the first subsequent anticancer therapy following study treatment or death by any cause, whichever is earlier, 7. PRO assessment of treatment using EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ EN24, 8. PK and immunogenicity of dostarlimab (Part 1 and Part 2) and PK of niraparib when administered in combination with dostarlimab (Part 2 only)
Interventions
DRUGJEMPERLI 500 mg concentrate for solution for infusion
DRUGNiraparib Placebo Capsules
DRUGG5W (5% glucose in water)
Sponsors
Tesaro Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints for Part 1: The primary efficacy endpoint of PFS is based on the investigator assessment, which is defined as the time from the date of randomization to the earliest date of radiographic assessment of PD or death by any cause in the absence of PD, whichever occurs first. Tumor response will be evaluated using RECIST v.1.1., Primary Endpoints for Part 1: The primary efficacy endpoint of overall survival is defined as the time from randomization to the date of death by any cause., Primary Endpoint for Part 2: The primary efficacy endpoint of PFS is based on the investigator assessment, which is defined as the time from the date of randomization to the earliest date of radiographic assessment of PD or death by any cause in the absence of PD, whichever occurs first. Tumor response will be evaluated using RECIST v.1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. OS, defined as the time from randomization to the date of death by any cause (Part 2 only)., 2. PFS based on BICR assessment, defined as the time from randomization to the earliest date of assessment of PD per RECIST v.1.1 or death by any cause in the absence of PD per RECIST v.1.1, whichever occurs first, 3. ORR based on BICR and Investigator assessment, defined as the proportion of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR), 4. DOR based on BICR and Investigator assessment, defined as the time from the first documentation of CR or PR until the time of the first documentation of subsequent PD per RECIST v.1.1 or death by any cause in the absence of PD per RECIST v.1.1, whichever occurs first, 5. DCR based on BICR and Investigator assessment, defined as the proportion of subjects who have achieved a BOR of CR, PR, or stable disease per RECIST v.1.1, 6. PFS2, defined as the time from treatment randomization to the date of assessment | — |
Countries
Belgium, Czechia, Denmark, Finland, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden
Outcome results
None listed