Trial · NCT03522246
A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
NCT03522246, Phase 3, Active not recruiting, pharmaand GmbH; results first posted 2025-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy. Trials, record NCT03522246. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03522246
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
- NCT number
- NCT03522246
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,097 participants, actual
- Lead sponsor
- pharmaand GmbH
- Conditions
- Epithelial Ovarian Cancer, Primary Peritoneal, Fallopian Tube Cancer, Newly Diagnosed, FIGO Stage III-IV, Partial Response, Complete Response
- Interventions
- Rucaparib, Nivolumab, Placebo Oral Tablet, Placebo IV Infusion
- First posted
- 2018-05-11
- Last updated
- 2025-06-24
- Other registries' IDs
- eudract:2017-004557-17
- Results first posted
- 2025-06-24
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS) | From randomization until disease progression (up to the primary data analysis at approximately 39 months) | PFS by investigator was defined as the time from randomization to disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). |
| Primary | Monotherapy Arm B and Arm D: Investigator Assessed PFS | From randomization until disease progression (up to the primary data analysis at approximately 39 months) | PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). |
| Primary | Combination Therapy Arm A and Arm B: Investigator Assessed PFS | From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months) | PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). |
| Secondary | Monotherapy Arm B and Arm D: Blinded Independent Central Review (BICR) PFS | From randomization until disease progression (up to the primary data analysis at approximately 39 months) | PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). |
| Secondary | Monotherapy Arm B and Arm D: BICR PFS | From randomization until disease progression (up to the primary data analysis at approximately 39 months) | PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). |
| Secondary | Combination Therapy Arm A and Arm B: BICR PFS | From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months) | PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). |
| Secondary | Monotherapy Arm B and Arm D: Overall Survival (OS) | From randomization until death due to any cause (up to the primary data analysis at approximately 36 months) | OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause. |
| Secondary | Monotherapy Arm B and Arm D: OS | From randomization until death due to any cause (up to the primary data analysis at approximately 40 months) | OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause. |
| Secondary | Combination Therapy Arm A and Arm B: OS | From randomization until death due to any cause (up to the combination therapy interim analysis at approximately 72 months) | OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause. |
| Secondary | Monotherapy Arm B and Arm D: Objective Response Rate (ORR) | From randomization until disease progression (up to the primary data analysis at approximately 39 months) | ORR was defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the Investigator per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS) | From randomization until disease progression (up to the primary data analysis at approximately 39 months) | The homologous recombination deficiency (HRD) population consisted of all randomized participants with either a tumor tissue alteration in breast cancer genes (BRCA)1 or BRCA2 (tBRCA) or non-tBRCA high loss of heterozygosity (LOHhigh). Presented here are data for the monotherapy comparison arms (Arm B and Arm D). | months | MEDIAN |
| PRIMARY | Monotherapy Arm B and Arm D: Investigator Assessed PFS | From randomization until disease progression (up to the primary data analysis at approximately 39 months) | The ITT population included all randomized participants. Presented here are data for the monotherapy comparison arms (Arm B and Arm D). | months | MEDIAN |
| PRIMARY | Combination Therapy Arm A and Arm B: Investigator Assessed PFS | From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months) | The ITT population included all randomized participants. Presented here are data from combination comparison arms (Arm A and Arm B). | months | MEDIAN |
| SECONDARY | Monotherapy Arm B and Arm D: Blinded Independent Central Review (BICR) PFS | From randomization until disease progression (up to the primary data analysis at approximately 39 months) | The HRD population consisted of all randomized participants with either tBRCA or non-tBRCA LOHhigh. Presented here are data from the monotherapy comparison arms (Arm B and Arm D). | months | MEDIAN |
| SECONDARY | Monotherapy Arm B and Arm D: BICR PFS | From randomization until disease progression (up to the primary data analysis at approximately 39 months) | The ITT population included all randomized participants. Presented here are data from the monotherapy comparison arms (Arm B and Arm D). | months | MEDIAN |
| SECONDARY | Combination Therapy Arm A and Arm B: BICR PFS | From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months) | BICR was included as a supportive secondary endpoint in the event that the Investigator-assessed PFS result was positive. In the ATHENA-COMBO statistical analysis plan it was specified that the BICR analysis would only be performed if the primary endpoint of Investigator-assessed PFS was statistically significant. Given that the result was negative and not statistically significant, the analysis of BICR was not performed, thus that data is not available and cannot be provided. | ||
| SECONDARY | Monotherapy Arm B and Arm D: Overall Survival (OS) | From randomization until death due to any cause (up to the primary data analysis at approximately 36 months) | The HRD population consisted of all randomized participants with either tBRCA or non-tBRCA LOHhigh. Presented here are data from the monotherapy comparison arms (Arm B and Arm D). | months | MEDIAN |
| SECONDARY | Monotherapy Arm B and Arm D: OS | From randomization until death due to any cause (up to the primary data analysis at approximately 40 months) | The ITT population included all randomized participants. Presented here are data from the monotherapy comparison arms (Arm B and Arm D). | months | MEDIAN |
| SECONDARY | Combination Therapy Arm A and Arm B: OS | From randomization until death due to any cause (up to the combination therapy interim analysis at approximately 72 months) | The ITT population included all randomized participants. Presented here are data from combination comparison arms (Arm A and Arm B). | months | MEDIAN |
| SECONDARY | Monotherapy Arm B and Arm D: Objective Response Rate (ORR) | From randomization until disease progression (up to the primary data analysis at approximately 39 months) | The HRD population consisted of all randomized participants with either tBRCA or non-tBRCA LOHhigh. Presented here are data from the monotherapy comparison arms (Arm B and Arm D). Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure with measurable disease at baseline. | percentage of participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS) | Arm B: Rucaparib + Placebo | 28.7 | 95% Confidence Interval 23.0 to NA | months | |
| Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS) | Arm D: Placebo + Placebo | 11.3 | 95% Confidence Interval 9.1 to 22.1 | months | |
| Monotherapy Arm B and Arm D: Investigator Assessed PFS | Arm B: Rucaparib + Placebo | 20.2 | 95% Confidence Interval 15.2 to 24.7 | months | |
| Monotherapy Arm B and Arm D: Investigator Assessed PFS | Arm D: Placebo + Placebo | 9.2 | 95% Confidence Interval 8.3 to 12.2 | months | |
| Combination Therapy Arm A and Arm B: Investigator Assessed PFS | Arm A: Rucaparib + Nivolumab | 15.0 | 95% Confidence Interval 12.1 to 17.4 | months | |
| Combination Therapy Arm A and Arm B: Investigator Assessed PFS | Arm B: Rucaparib + Placebo | 20.2 | 95% Confidence Interval 15.6 to 24.0 | months | |
| Monotherapy Arm B and Arm D: Blinded Independent Central Review (BICR) PFS | Arm B: Rucaparib + Placebo | NA | 95% Confidence Interval 28.7 to NA | months | |
| Monotherapy Arm B and Arm D: Blinded Independent Central Review (BICR) PFS | Arm D: Placebo + Placebo | 9.9 | 95% Confidence Interval 6.5 to NA | months | |
| Monotherapy Arm B and Arm D: BICR PFS | Arm B: Rucaparib + Placebo | 25.9 | 95% Confidence Interval 16.8 to NA | months | |
| Monotherapy Arm B and Arm D: BICR PFS | Arm D: Placebo + Placebo | 9.1 | 95% Confidence Interval 6.4 to 9.7 | months |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow25
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Rucaparib + Nivolumab | 436 | |
| Overall Study | STARTED | Arm B: Rucaparib + Placebo | 427 | |
| Overall Study | STARTED | Arm C: Placebo + Nivolumab | 108 | |
| Overall Study | STARTED | Arm D: Placebo + Placebo | 111 | |
| Overall Study | STARTED | Japanese Open-label Safety Cohort: Rucaparib + Nivolumab | 15 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Arm A: Rucaparib + Nivolumab | 433 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Arm B: Rucaparib + Placebo | 425 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Arm C: Placebo + Nivolumab | 108 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Arm D: Placebo + Placebo | 110 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Japanese Open-label Safety Cohort: Rucaparib + Nivolumab | 15 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events1,415
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 | Arm A: Rucaparib + Nivolumab | 198 | 410 | 789 |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: Rucaparib + Placebo | 198 | 448 | 778 |
| other | Anaemia | Blood and lymphatic system disorders | Arm C: Placebo + Nivolumab | 10 | 107 | 23 |
| other | Anaemia | Blood and lymphatic system disorders | Arm D: Placebo + Placebo | 11 | 111 | 23 |
| other | Anaemia | Blood and lymphatic system disorders | Japanese Open-label Safety Cohort: Rucaparib + Nivolumab | 12 | 15 | 49 |
| other | Leukopenia | Blood and lymphatic system disorders | Arm A: Rucaparib + Nivolumab | 40 | 410 | 118 |
| other | Leukopenia | Blood and lymphatic system disorders | Arm B: Rucaparib + Placebo | 18 | 448 | 69 |
| other | Leukopenia | Blood and lymphatic system disorders | Arm C: Placebo + Nivolumab | 1 | 107 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Arm D: Placebo + Placebo | 3 | 111 | 8 |
| other | Leukopenia | Blood and lymphatic system disorders | Japanese Open-label Safety Cohort: Rucaparib + Nivolumab | 4 | 15 | 7 |
1 to 10 of 1,415Source ClinicalTrials.gov
See all 1,415 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Rucaparib + Nivolumab | 12 | 410 |
| Total, all-cause mortality | Arm B: Rucaparib + Placebo | 20 | 448 |
| Total, all-cause mortality | Arm C: Placebo + Nivolumab | 4 | 107 |
| Total, all-cause mortality | Arm D: Placebo + Placebo | 2 | 111 |
| Total, all-cause mortality | Japanese Open-label Safety Cohort: Rucaparib + Nivolumab | 0 | 15 |
| Total, other adverse events | Arm A: Rucaparib + Nivolumab | 406 | 410 |
| Total, other adverse events | Arm B: Rucaparib + Placebo | 433 | 448 |
| Total, other adverse events | Arm C: Placebo + Nivolumab | 99 | 107 |
| Total, other adverse events | Arm D: Placebo + Placebo | 103 | 111 |
| Total, other adverse events | Japanese Open-label Safety Cohort: Rucaparib + Nivolumab | 15 | 15 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
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 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.
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/NCT03522246
GET https://conductscience.org/api/trials/v1/NCT03522246/results?page=2