Trial · NCT05116189
Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65).
NCT05116189, Phase 3, Active not recruiting, Merck Sharp & Dohme LLC; results first posted 2026-03-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65). Trials, record NCT05116189. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05116189
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65).
- NCT number
- NCT05116189
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 643 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Ovarian Cancer, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
- Interventions
- Pembrolizumab, Paclitaxel, Bevacizumab, Placebo for pembrolizumab, Docetaxel
- First posted
- 2021-11-10
- Last updated
- 2026-03-09
- Other registries' IDs
- eudract:2020-005027-37
- Results first posted
- 2026-03-09
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS] ≥1) | Up to ~38 months | PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. Per protocol, PFS per RECIST 1.1 as assessed by the Investigator in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. |
| Primary | PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants | Up to ~38 months | PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. PFS per RECIST 1.1 as assessed by the Investigator will be reported for all participants. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1 | Up to ~38 months | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review (BICR) in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in All Participants | Up to ~38 months | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review (BICR) in all participants is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | Overall Survival (OS) | Up to ~64 months | OS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants. |
| Secondary | Number of Participants Who Experience an Adverse Event (AE) | Up to ~64 months | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. |
| Secondary | Number of Participants Who Discontinue Study Treatment Due to an AE | Up to ~64 months | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported. |
| Secondary | 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) | Baseline and up to ~64 months | The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented. |
| Secondary | Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30 | Up to ~64 months | TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Items 29 and 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome. |
| Secondary | 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 | Baseline and up to ~64 months | The EORTC QLQ-OV28 is an abdominal and gastrointestinal questionnaire (items 31-36). Participant responses to the question "Did you have abdominal pain ?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-LC28 Items 31-36) score will be presented. A lower score indicates a better outcome. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS] ≥1) | Up to ~38 months | The analysis population includes all randomized participants with PD-L1 positive tumors (CPS≥1). Participants were analyzed in the treatment group to which they are randomized. | Months | MEDIAN |
| PRIMARY | PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants | Up to ~38 months | The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they are randomized. | Months | MEDIAN |
| SECONDARY | PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1 | Up to ~38 months | The analysis population includes all randomized participants with PD-L1 positive tumors (CPS≥1). Participants were analyzed in the treatment group to which they are randomized. | Months | MEDIAN |
| SECONDARY | PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in All Participants | Up to ~38 months | The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they are randomized. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to ~64 months | |||
| SECONDARY | Number of Participants Who Experience an Adverse Event (AE) | Up to ~64 months | |||
| SECONDARY | Number of Participants Who Discontinue Study Treatment Due to an AE | Up to ~64 months | |||
| SECONDARY | 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) | Baseline and up to ~64 months | |||
| SECONDARY | Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30 | Up to ~64 months | |||
| SECONDARY | 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 | Baseline and up to ~64 months |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS] ≥1) | Pembrolizumab + Paclitaxel ± Bevacizumab | 8.3 | 95% Confidence Interval 7.0 to 9.5 | Months | |
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS] ≥1) | Placebo + Paclitaxel ± Bevacizumab | 7.2 | 95% Confidence Interval 6.2 to 8.1 | Months | |
| PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants | Pembrolizumab + Paclitaxel ± Bevacizumab | 8.3 | 95% Confidence Interval 7.2 to 8.6 | Months | |
| PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants | Placebo + Paclitaxel ± Bevacizumab | 6.4 | 95% Confidence Interval 6.2 to 8.1 | Months | |
| PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1 | Pembrolizumab + Paclitaxel ± Bevacizumab | 8.5 | 95% Confidence Interval 8.1 to 10.4 | Months | |
| PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1 | Placebo + Paclitaxel ± Bevacizumab | 7.6 | 95% Confidence Interval 6.2 to 8.3 | Months | |
| PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in All Participants | Pembrolizumab + Paclitaxel ± Bevacizumab | 8.4 | 95% Confidence Interval 8.1 to 10.3 | Months | |
| PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in All Participants | Placebo + Paclitaxel ± Bevacizumab | 6.4 | 95% Confidence Interval 6.2 to 8.2 | Months |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab + Paclitaxel ± Bevacizumab | 322 | |
| Overall Study | STARTED | Placebo + Paclitaxel ± Bevacizumab | 321 | |
| Overall Study | Treated | Pembrolizumab + Paclitaxel ± Bevacizumab | 320 | |
| Overall Study | Treated | Placebo + Paclitaxel ± Bevacizumab | 318 | |
| Overall Study | COMPLETED | Pembrolizumab + Paclitaxel ± Bevacizumab | 0 | |
| Overall Study | COMPLETED | Placebo + Paclitaxel ± Bevacizumab | 0 | |
| Overall Study | NOT COMPLETED | Pembrolizumab + Paclitaxel ± Bevacizumab | 322 | |
| Overall Study | NOT COMPLETED | Placebo + Paclitaxel ± Bevacizumab | 321 |
Source ClinicalTrials.gov
Adverse events590
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab + Paclitaxel ± Bevacizumab | 169 | 320 | 365 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Paclitaxel ± Bevacizumab | 148 | 318 | 263 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab + Paclitaxel ± Bevacizumab | 24 | 320 | 77 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + Paclitaxel ± Bevacizumab | 27 | 318 | 100 |
| other | Neutropenia | Blood and lymphatic system disorders | Pembrolizumab + Paclitaxel ± Bevacizumab | 76 | 320 | 186 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Paclitaxel ± Bevacizumab | 81 | 318 | 205 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab + Paclitaxel ± Bevacizumab | 57 | 320 | 67 |
| other | Hypothyroidism | Endocrine disorders | Placebo + Paclitaxel ± Bevacizumab | 19 | 318 | 23 |
| other | Abdominal distension | Gastrointestinal disorders | Pembrolizumab + Paclitaxel ± Bevacizumab | 24 | 320 | 30 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo + Paclitaxel ± Bevacizumab | 26 | 318 | 29 |
1 to 10 of 590Source ClinicalTrials.gov
See all 590 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab + Paclitaxel ± Bevacizumab | 225 | 322 |
| Total, all-cause mortality | Placebo + Paclitaxel ± Bevacizumab | 244 | 321 |
| Total, other adverse events | Pembrolizumab + Paclitaxel ± Bevacizumab | 319 | 320 |
| Total, other adverse events | Placebo + Paclitaxel ± Bevacizumab | 307 | 318 |
| Total, serious adverse events | Pembrolizumab + Paclitaxel ± Bevacizumab | 178 | 320 |
| Total, serious adverse events | Placebo + Paclitaxel ± Bevacizumab | 122 | 318 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pembrolizumab + Paclitaxel ± Bevacizumab vs Placebo + Paclitaxel ± Bevacizumab: deaths from any cause | Trial comparisons |
| Pembrolizumab + Paclitaxel ± Bevacizumab vs Placebo + Paclitaxel ± Bevacizumab: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05116189
GET https://conductscience.org/api/trials/v1/NCT05116189/events?page=2