An open label phase II basket trial exploring the efficacy and safety of the combination of Niraparib and Dostarlimab in patients with DNA repair-deficient or platinum-sensitive solid tumors (NIRADO)

Conditions

DNA repair-deficient or platinum-sensitive solid tumors

Brief summary

Overall Response Rate (ORR) at 15 weeks according to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1).

Detailed description

Overall Reponse Rate (ORR) at 21 weeks according to RECIST v1.1, Overall response rate (ORR) at 15 and 21 weeks according to iRECIST., Best overall response (BOR) according to RECIST v1.1, Duration of response (DOR) according to RECIST v1.1, Progression-free survival (PFS) according to RECIST v1.1, Time to tumor progression (TTP) according to RECIST v1.1, iTTP according iRECIST, iPFS according to iRECIST, Best overall response (iBOR) according to iRECIST, Duration of response (iDOR) according to iRECIST., Disease control rate (DCR) according to RECIST v1.1 and iRECIST, Maximum percentage of shrinkage from baseline in the sum of the reference diameters of the target lesions (selected according to RECIST and iRECIST), Overall Survival, Safety according to CTCAE v. 5.0, Quality of life according to EORTC-QLQ30

Related papers

No related papers found yet.

Interventions

DRUGJEMPERLI 500 mg concentrate for solution for infusion

DRUGZejula 100 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Response Rate (ORR) at 15 weeks according to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1).	—

Secondary

Measure	Time frame
Overall Reponse Rate (ORR) at 21 weeks according to RECIST v1.1, Overall response rate (ORR) at 15 and 21 weeks according to iRECIST., Best overall response (BOR) according to RECIST v1.1, Duration of response (DOR) according to RECIST v1.1, Progression-free survival (PFS) according to RECIST v1.1, Time to tumor progression (TTP) according to RECIST v1.1, iTTP according iRECIST, iPFS according to iRECIST, Best overall response (iBOR) according to iRECIST, Duration of response (iDOR) according to iRECIST., Disease control rate (DCR) according to RECIST v1.1 and iRECIST, Maximum percentage of shrinkage from baseline in the sum of the reference diameters of the target lesions (selected according to RECIST and iRECIST), Overall Survival, Safety according to CTCAE v. 5.0, Quality of life according to EORTC-QLQ30	—

Measure

Time frame

Overall Reponse Rate (ORR) at 21 weeks according to RECIST v1.1, Overall response rate (ORR) at 15 and 21 weeks according to iRECIST., Best overall response (BOR) according to RECIST v1.1, Duration of response (DOR) according to RECIST v1.1, Progression-free survival (PFS) according to RECIST v1.1, Time to tumor progression (TTP) according to RECIST v1.1, iTTP according iRECIST, iPFS according to iRECIST, Best overall response (iBOR) according to iRECIST, Duration of response (iDOR) according to iRECIST., Disease control rate (DCR) according to RECIST v1.1 and iRECIST, Maximum percentage of shrinkage from baseline in the sum of the reference diameters of the target lesions (selected according to RECIST and iRECIST), Overall Survival, Safety according to CTCAE v. 5.0, Quality of life according to EORTC-QLQ30

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Countries

France

Outcome results

None listed