A Randomized Clinical Trial Investigating Olaparib, Durvalumab (MEDI4736) and UV1 as Maintenance Therapy in BRCAwt Patients with Recurrent Ovarian Cancer.

Conditions

Ovarian cancer

Brief summary

Progression-free survival (PFS) arm A versus C.

Detailed description

PFS arm B versus arm C, Assessment of PROs, PFS assessed by blinded independent central review (BICR), Efficacy according to stratification factors, Efficacy according to PD-L1 status, Overall survival (OS), Time to first subsequent therapy (TFST), Subsequent progression (PFS2), Time to second subsequent therapy (TSST), Objective Response Rate (ORR), Disease Control Rate (DCR), Safety analysis., Exploratory endpoint: Evaluation of changes in genetic, molecular, and immunological markers of response and/or resistance over time., Exploratory endpoint: Correlation between changes in genetic, molecular, and immunological markers and efficacy in defined subgroups.

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGLeukine

DRUGLynparza 100 mg film-coated tablets

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

DRUGLynparza 150 mg film-coated tablets

DRUGUV1

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) arm A versus C.	—

Secondary

Measure	Time frame
PFS arm B versus arm C, Assessment of PROs, PFS assessed by blinded independent central review (BICR), Efficacy according to stratification factors, Efficacy according to PD-L1 status, Overall survival (OS), Time to first subsequent therapy (TFST), Subsequent progression (PFS2), Time to second subsequent therapy (TSST), Objective Response Rate (ORR), Disease Control Rate (DCR), Safety analysis., Exploratory endpoint: Evaluation of changes in genetic, molecular, and immunological markers of response and/or resistance over time., Exploratory endpoint: Correlation between changes in genetic, molecular, and immunological markers and efficacy in defined subgroups.	—

Measure

Time frame

PFS arm B versus arm C, Assessment of PROs, PFS assessed by blinded independent central review (BICR), Efficacy according to stratification factors, Efficacy according to PD-L1 status, Overall survival (OS), Time to first subsequent therapy (TFST), Subsequent progression (PFS2), Time to second subsequent therapy (TSST), Objective Response Rate (ORR), Disease Control Rate (DCR), Safety analysis., Exploratory endpoint: Evaluation of changes in genetic, molecular, and immunological markers of response and/or resistance over time., Exploratory endpoint: Correlation between changes in genetic, molecular, and immunological markers and efficacy in defined subgroups.

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Countries

Austria, Belgium, Denmark, Finland, Germany, Lithuania, Netherlands, Norway, Sweden

Outcome results

None listed