Trial · NCT06580314
Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer
NCT06580314, Phase 3, Recruiting, NRG Oncology
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer. Trials, record NCT06580314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06580314
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer
- NCT number
- NCT06580314
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 880 participants, estimated
- Lead sponsor
- NRG Oncology
- Conditions
Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, Fallopian Tube Malignant Mixed Mesodermal (Mullerian) Tumor, FIGO Stage III Ovarian Cancer 2014, FIGO Stage IV Ovarian Cancer 2014, Ovarian Carcinoma, Ovarian Carcinosarcoma, Ovarian High Grade Endometrioid Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Primary Peritoneal Carcinosarcoma, Primary Peritoneal Endometrioid Adenocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma
- Interventions
- Bevacizumab, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Olaparib
- First posted
- 2024-08-30
- Last updated
- 2026-11-09
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression free survival (PFS) at least 360 days after randomization (PFS360) | From completing 360 days of maintenance therapy to disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1) or death, whichever occurs first, assessed up to 5 years | PFS will be tested using a one-sided, alpha = 0.05 level logrank test. Treatment hazard ratios and their 90% confidence intervals will be estimated using a Cox proportional hazards model specified with a main effect for the randomized treatment assignment and stratified using the stratification factors applied at randomization. |
| Secondary | Overall survival (OS) 360 | From 360 days after randomization to death from any cause, assessed up to 5 years | This endpoint will be supported by the modified intent to treat (ITT) population, which excludes progressions, deaths or withdrawals within 359 days of randomization. Will be summarized using treatment hazard ratio estimates (90% confidence intervals). These estimates will be obtained from outcome-specific Cox-regression models specified with main effects for the randomized treatment and stratified by the factors included in the randomization. OS distributions will be summarized using methods developed by Kaplan-Meier. |
| Secondary | PFS | From randomization to progression or death, whichever occurs first, or date of the last computed tomography scan if neither progression nor death has occurred, assessed up to 5 years | Will be analyzed in the ITT population and serve as a sensitivity analysis for the primary endpoint. Will be summarized using treatment hazard ratio estimates (90% confidence intervals). These estimates will be obtained from outcome-specific Cox-regression models specified with main effects for the randomized treatment and stratified by the factors included in the randomization. PFS distributions will be summarized using methods developed by Kaplan-Meier. |
| Secondary | PFS2 | From randomization to objective tumor progression on next-line treatment or death, assessed up to 5 years | PFS2 may be identified by objective radiological progression using Response Evaluation Criteria in Solid Tumors version (v)1.1., symptomatic deterioration or death. PFS2 will be summarized using treatment hazard ratio estimates (90% confidence intervals). These estimates will be obtained from outcome-specific Cox-regression models specified with main effects for the randomized treatment and stratified by the factors included in the randomization. PFS2 distributions will be summarized using methods developed by Kaplan-Meier. |
| Secondary | OS | From randomization to death, assessed up to 5 years | OS will be summarized using treatment hazard ratio estimates (90% confidence intervals). These estimates will be obtained from outcome-specific Cox-regression models specified with main effects for the randomized treatment and stratified by the factors included in the randomization. OS distributions will be summarized using methods developed by Kaplan-Meier. |
| Secondary | Incidence of adverse events (AEs) | Up to 30 days after last dose of study treatment | Safety and tolerability will be graded using Common Terminology Criteria for Adverse Events v 5.0. AEs will be summarized by system organ class and preferred term according to the maximum grade observed for each patient. |
| Other | Effect of bevacizumab on PFS | Up to 5 years | The estimates will be obtained from outcome-specific Cox regression models specified with main effects for the assigned treatment arm, physician-choice bevacizumab and the interaction term. The overall effect of bevacizumab will be described by the score test p value for the interaction term. Descriptively, the bevacizumab effect will be summarized using the randomized treatment hazard ratio estimates (95% confidence intervals) within the bevacizumab and no-bevacizumab subgroups (as stratified). PFS outcome distributions will further be described using methods developed by Kaplan-Meier. |
| Other | Effect of bevacizumab on OS | Up to 5 years | The estimates will be obtained from outcome-specific Cox regression models specified with main effects for the assigned treatment arm, physician-choice bevacizumab and the interaction term. The overall effect of bevacizumab will be described by the score test p value for the interaction term. Descriptively, the bevacizumab effect will be summarized using the randomized treatment hazard ratio estimates (95% confidence intervals) within the bevacizumab and no-bevacizumab subgroups (as stratified). OS outcome distributions will further be described using methods developed by Kaplan-Meier. |
| Other | Effect of bevacizumab on PFS2 | Up to 5 years | The estimates will be obtained from outcome-specific Cox regression models specified with main effects for the assigned treatment arm, physician-choice bevacizumab and the interaction term. The overall effect of bevacizumab will be described by the score test p value for the interaction term. Descriptively, the bevacizumab effect will be summarized using the randomized treatment hazard ratio estimates (95% confidence intervals) within the bevacizumab and no-bevacizumab subgroups (as stratified). PFS2 outcome distributions will further be described using methods developed by Kaplan-Meier. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
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/NCT06580314
GET https://conductscience.org/api/trials/v1/NCT06580314/registered