Return to Clinical Trials Search Results

MK3475 Protocol B96: 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)

To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator Hypothesis (H1): pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score [CPS] greater than or equal to1) Hypothesis (H2): pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to overall survival (OS) Hypothesis (H3): Pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to OS for participants with PD-L1 positive tumors (CPS greater than or equal to1) Hypothesis (H4): Pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to OS for all participants To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 by blinded independent central review (BICR) for participants with PD-L1 positive tumors (CPS greater than or equal to1) and all participants To evaluate the safety and tolerability of pembrolizumab in combination with paclitaxel with or without bevacizumab To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to Global Health Status/Quality of Life (GHS/QoL) score using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and abdominal and gastrointestinal (GI) symptoms using the EORTC Ovarian Cancer- Specific Quality of Life Questionnaire (QLQ-OV28) abdominal/GI symptom scale for participants with PD-L1 positive tumors (CPS greater than or equal to 1) and all participants

To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator Hypothesis (H1): pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score [CPS] greater than or equal to1) Hypothesis (H2): pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to overall survival (OS) Hypothesis (H3): Pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to OS for participants with PD-L1 positive tumors (CPS greater than or equal to1) Hypothesis (H4): Pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to OS for all participants To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 by blinded independent central review (BICR) for participants with PD-L1 positive tumors (CPS greater than or equal to1) and all participants To evaluate the safety and tolerability of pembrolizumab in combination with paclitaxel with or without bevacizumab To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to Global Health Status/Quality of Life (GHS/QoL) score using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and abdominal and gastrointestinal (GI) symptoms using the EORTC Ovarian Cancer- Specific Quality of Life Questionnaire (QLQ-OV28) abdominal/GI symptom scale for participants with PD-L1 positive tumors (CPS greater than or equal to 1) and all participants