A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96 / ENGOT-ov65).

Conditions

fallopian tube, or primary peritoneal carcinoma., Ovarian

Brief summary

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator.

Detailed description

Overall Survival (OS)., PFS per RECIST 1.1 by Blinded Independent Central Review (BICR)., Number of Participants who Experience an Adverse Event (AE)., Number of Participants who Discontinue Study Treatment due to an AE., Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30., Change From Baseline in the Abdominal and Gastrointestinal (GI) Symptoms Score (Items 31 to 36) Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale., TTD in the Abdominal and GI Symptoms Score (Items 31 to 36) Using the EORTC QLQ-OV28 Abdominal/GI Symptom Scale.

Related papers

No related papers found yet.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGDOCETAXEL

DRUGPACLITAXEL

DRUGNormal saline or dextrose

DRUGBEVACIZUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator.	—

Secondary

Measure	Time frame
Overall Survival (OS)., PFS per RECIST 1.1 by Blinded Independent Central Review (BICR)., Number of Participants who Experience an Adverse Event (AE)., Number of Participants who Discontinue Study Treatment due to an AE., Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30., Change From Baseline in the Abdominal and Gastrointestinal (GI) Symptoms Score (Items 31 to 36) Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale., TTD in the Abdominal and GI Symptoms Score (Items 31 to 36) Using the EORTC QLQ-OV28 Abdominal/GI Symptom Scale.	—

Measure

Time frame

Overall Survival (OS)., PFS per RECIST 1.1 by Blinded Independent Central Review (BICR)., Number of Participants who Experience an Adverse Event (AE)., Number of Participants who Discontinue Study Treatment due to an AE., Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30., Change From Baseline in the Abdominal and Gastrointestinal (GI) Symptoms Score (Items 31 to 36) Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale., TTD in the Abdominal and GI Symptoms Score (Items 31 to 36) Using the EORTC QLQ-OV28 Abdominal/GI Symptom Scale.

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Countries

Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland

Outcome results

None listed