Trial · NCT03740165
Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036)
NCT03740165, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2025-09-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036). Trials, record NCT03740165. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03740165
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036)
- NCT number
- NCT03740165
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,367 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms
- Interventions
- Pembrolizumab, Placebo for pembrolizumab, Carboplatin, Paclitaxel, Olaparib, Placebo for olaparib, Bevacizumab, Docetaxel
- First posted
- 2018-11-14
- Last updated
- 2026-08-19
- Other registries' IDs
- eudract:2018-001973-25
- Results first posted
- 2025-09-12
Source ClinicalTrials.gov
Registered outcomes22
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 Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS]≥10) | Up to approximately 67 months | PFS is 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 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. Note: The appearance of one or more new lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for participants with PD-L1 positive tumors (CPS≥10). 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 approximately 67 months | PFS is 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 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. Note: The appearance of one or more new lesions and the unequivocal progression of non-target lesions is also considered PD. The 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 | Overall Survival (OS) in Participants With PD-L1 Positive Tumors (CPS ≥ 10) | Up to approximately 67 months | OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all participants with PD-L1 positive tumors (CPS≥10). The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | OS in All Participants | Up to approximately 67 months | OS is defined as the time from the date of randomization to death due to any cause. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR) in Participants With PD-L1 Positive Tumors (CPS≥10) | Up to approximately 66 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. Note: The appearance of one or more new 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 will be reported for participants with PD-L1 positive (CPS≥10) tumors (CPS≥10). PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | PFS Per RECIST 1.1 as Assessed by BICR in All Participants | Up to approximately 66 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. Note: The appearance of one or more new 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 will be reported for all participants. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | PFS After Second-line Treatment (PFS2) Following Discontinuation of Study Treatment as Assessed by the Investigator in Participants With PD-L1 Positive Tumors (CPS≥10) | Up to approximately 67 months | PFS2 is defined as the time from randomization until PD after second-line treatment per RECIST 1.1 based on Investigator 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. Note: The appearance of one or more new lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS2 per RECIST 1.1 as assessed by the Investigator is reported for participants with PD-L1 positive tumors (CPS≥10). PFS2 was calculated using the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | PFS2 Following Discontinuation of Study Treatment as Assessed by the Investigator in All Participants | Up to approximately 67 months | PFS2 is defined as the time from randomization until PD after second-line treatment per RECIST 1.1 based on Investigator 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. Note: The appearance of one or more new lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS2 per RECIST 1.1 as assessed by the Investigator is reported for all participants. PFS2 was calculated using the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) (GHS/QoL) Combined Score | Baseline and week 45 | The EORTC-QLQ-C30 is a 30-item questionnaire to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor; 7=Excellent). Using linear transformation, raw scores were standardized so scores ranged from 0 to 100; higher score = better outcome. Change from baseline to Week 45 in EORTC QLQ-C30 Items 29 and 30 combined scores was calculated based on a constrained longitudinal data analysis (cLDA) with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], and bevacizumab use \[Yes vs No\], and PD-L1 CPS \[\<10 vs ≥10\]). |
| Secondary | Mean Change From Baseline in Abdominal and Gastrointestinal (Abdominal/GI) Symptoms Score Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale | Baseline and week 45 | Participant responses to 6 questions from the EORTC QoL Questionnaire-Ovarian Cancer (QLQ-OV28) abdominal/GI symptom scale about abdominal pain, bloated feeling in abdomen/stomach, changes in clothing fit, changes in bowel habit, flatulence, and stomach fullness when eating (questions 31-36) were scored on a 4-point scale (1=Not at all; 4=Very much); lower score = better abdominal/GI symptoms. Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100; a lower score indicating a better overall outcome. Change from baseline to Week 45 in EORTC QLQ-OV28 Items 31-36 combined scores was calculated based on a constrained longitudinal data analysis (cLDA) model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], and bevacizumab use \[Yes vs No\], and PD-L1 CPS \[\<10 vs ≥10\]). |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
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 Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS]≥10) | Up to approximately 67 months | The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| PRIMARY | PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants | Up to approximately 67 months | The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in Participants With PD-L1 Positive Tumors (CPS ≥ 10) | Up to approximately 67 months | The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | OS in All Participants | Up to approximately 67 months | The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR) in Participants With PD-L1 Positive Tumors (CPS≥10) | Up to approximately 66 months | The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | PFS Per RECIST 1.1 as Assessed by BICR in All Participants | Up to approximately 66 months | The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | PFS After Second-line Treatment (PFS2) Following Discontinuation of Study Treatment as Assessed by the Investigator in Participants With PD-L1 Positive Tumors (CPS≥10) | Up to approximately 67 months | The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | PFS2 Following Discontinuation of Study Treatment as Assessed by the Investigator in All Participants | Up to approximately 67 months | The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) (GHS/QoL) Combined Score | Baseline and week 45 | The analysis population includes all randomized participants who have at least 1 GHS/QoL assessment available and received at least 1 dose of study medication. Participants were analyzed in the treatment group to which they were randomized. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Abdominal and Gastrointestinal (Abdominal/GI) Symptoms Score Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale | Baseline and week 45 | The analysis population includes all randomized participants who have at least 1 Abdominal/GI Symptom Scale assessment available and received at least 1 dose of study medication. Participants were analyzed in the treatment group to which they were randomized. | Score on a Scale | LEAST_SQUARES_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group60
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 Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS]≥10) | Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | 23.9 | 95% Confidence Interval 21.0 to 30.2 | 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 Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS]≥10) | Carboplatin + Paclitaxel + Pembrolizumab | 17.3 | 95% Confidence Interval 15.2 to 19.4 | 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 Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS]≥10) | Carboplatin + Paclitaxel | 15.2 | 95% Confidence Interval 12.5 to 17.2 | Months | |
| PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants | Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | 22.2 | 95% Confidence Interval 18.8 to 24.7 | Months | |
| PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants | Carboplatin + Paclitaxel + Pembrolizumab | 15.2 | 95% Confidence Interval 13.6 to 16.4 | Months | |
| PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants | Carboplatin + Paclitaxel | 14.6 | 95% Confidence Interval 12.7 to 16.3 | Months | |
| Overall Survival (OS) in Participants With PD-L1 Positive Tumors (CPS ≥ 10) | Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | 50.2 | 95% Confidence Interval 43.9 to NA | Months | |
| Overall Survival (OS) in Participants With PD-L1 Positive Tumors (CPS ≥ 10) | Carboplatin + Paclitaxel + Pembrolizumab | 56.4 | 95% Confidence Interval 42.4 to NA | Months | |
| Overall Survival (OS) in Participants With PD-L1 Positive Tumors (CPS ≥ 10) | Carboplatin + Paclitaxel | 51.6 | 95% Confidence Interval 41.8 to NA | Months | |
| OS in All Participants | Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | 47.7 | 95% Confidence Interval 42.3 to 54.9 | Months |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | 455 | |
| Overall Study | STARTED | Carboplatin + Paclitaxel + Pembrolizumab | 458 | |
| Overall Study | STARTED | Carboplatin + Paclitaxel | 454 | |
| Overall Study | Treated | Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | 452 | |
| Overall Study | Treated | Carboplatin + Paclitaxel + Pembrolizumab | 456 | |
| Overall Study | Treated | Carboplatin + Paclitaxel | 454 | |
| Overall Study | COMPLETED | Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | 0 | |
| Overall Study | COMPLETED | Carboplatin + Paclitaxel + Pembrolizumab | 0 | |
| Overall Study | COMPLETED | Carboplatin + Paclitaxel | 0 | |
| Overall Study | NOT COMPLETED | Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | 455 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,209
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 | Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | 270 | 452 | 488 |
| other | Anaemia | Blood and lymphatic system disorders | Carboplatin + Paclitaxel + Pembrolizumab | 212 | 456 | 344 |
| other | Anaemia | Blood and lymphatic system disorders | Carboplatin + Paclitaxel | 205 | 454 | 322 |
| other | Leukopenia | Blood and lymphatic system disorders | Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | 90 | 452 | 201 |
| other | Leukopenia | Blood and lymphatic system disorders | Carboplatin + Paclitaxel + Pembrolizumab | 60 | 456 | 110 |
| other | Leukopenia | Blood and lymphatic system disorders | Carboplatin + Paclitaxel | 60 | 454 | 113 |
| other | Neutropenia | Blood and lymphatic system disorders | Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | 170 | 452 | 437 |
| other | Neutropenia | Blood and lymphatic system disorders | Carboplatin + Paclitaxel + Pembrolizumab | 138 | 456 | 309 |
| other | Neutropenia | Blood and lymphatic system disorders | Carboplatin + Paclitaxel | 147 | 454 | 317 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | 89 | 452 | 180 |
1 to 10 of 1,209Source ClinicalTrials.gov
See all 1,209 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | 237 | 455 |
| Total, all-cause mortality | Carboplatin + Paclitaxel + Pembrolizumab | 243 | 458 |
| Total, all-cause mortality | Carboplatin + Paclitaxel | 229 | 454 |
| Total, other adverse events | Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | 445 | 452 |
| Total, other adverse events | Carboplatin + Paclitaxel + Pembrolizumab | 442 | 456 |
| Total, other adverse events | Carboplatin + Paclitaxel | 445 | 454 |
| Total, serious adverse events | Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | 205 | 452 |
| Total, serious adverse events | Carboplatin + Paclitaxel + Pembrolizumab | 179 | 456 |
| Total, serious adverse events | Carboplatin + Paclitaxel | 122 | 454 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42705254 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT03740165
GET https://conductscience.org/api/trials/v1/NCT03740165/registered?page=2