Trial · NCT07504588
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
NCT07504588, Phase 2, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy. Trials, record NCT07504588. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07504588
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
- NCT number
- NCT07504588
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 87 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma, Recurrent Platinum-Sensitive Ovarian High Grade Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Ovarian High Grade Serous Adenocarcinoma, Recurrent Platinum-Sensitive Primary Peritoneal Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Primary Peritoneal High Grade Serous Adenocarcinoma
- Interventions
Anti-VEGF Monoclonal Antibody, Bevacizumab, Biospecimen Collection, Carboplatin, Computed Tomography, Echocardiography Test, Gemcitabine, Magnetic Resonance Imaging, Multigated Acquisition Scan, Pegylated Liposomal Doxorubicin Hydrochloride, Sacituzumab Govitecan
- First posted
- 2026-04-01
- 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 | From randomization to either progressive disease or death from any cause, assessed up to 5 years | The primary analysis will compare progression-free survival between Arm II and Arm I using a stratified log-rank test. The corresponding hazard ratio will be estimated from a stratified Cox regression model. The treatment hazard ratio estimate and its 95% confidence interval will be estimated using proportional hazards models specified to be consistent with the logrank tests. |
| Secondary | Objective response rate (ORR) | Within 12 months of starting maintenance therapy | The ORR is the percentage of evaluable patients who achieve a complete response (CR) or partial response (PR) within 12 months of starting maintenance therapy. The analysis will be based on physician-assessed responses according to Response Evaluation Criteria in Solid Tumors 1.1 criteria. Comparisons of ORR between the experimental and reference groups will use a multivariable logistic regression model, stratified by the randomization factors, to estimate the odds ratio. A 95% Jeffries confidence interval will also be calculated for the ORR in each treatment arm. |
| Secondary | Duration of response (DOR) | From the first documented response (CR or PR) until disease progression or death, assessed up to 5 years | DOR will be visualized using Kaplan-Meier curves, and the treatment groups will be compared with a stratified log-rank test. A stratified Cox proportional hazards model will be used to estimate the hazard ratio for progression or death between the groups. |
| Secondary | Incidence of adverse events | Up to 5 years | The nature, frequency, and degree of toxicity will be tabulated at the System Organ Class and adverse event-specific term levels using Common Terminology Criteria for Adverse Events version 5.0. Each patient will be represented according to the maximum grade observed for each term. Tabulations will show the number and percentage of patients by maximum grade, within the treatment group received, regardless of the randomized treatment assignment. |
| Secondary | Overall survival | From randomization to death from any cause, assessed up to 5 years | Estimates of treatment effect will be interpreted descriptively with associated confidence intervals, without formal hypothesis testing. |
| Other | TROP2 expression | Up to 5 years | TROP2 expression will be correlated with clinical activity of sacituzumab govitecan (SG) and bevacizumab to assess how the clinical effect of the randomized treatment is modified by TROP2 expression. Will formally test the interaction between the biomarker and the treatment assignment to assess whether this is a predictive biomarker. A logistic regression model will be used to test the treatment-by-TROP2 interaction on the odds of achieving a response. The odds ratio for the treatment effect will be estimated within each TROP2 subgroup. A Cox proportional hazards model will be fitted with main effects for treatment, TROP2 status, and a treatment-by-TROP2 interaction term. A statistically significant interaction term would suggest TROP2 is a predictive biomarker. The treatment effect will be estimated and displayed on a forest plot for TROP2-high and TROP2-low subgroups. Kaplan-Meier curves for PFS will be plotted for each treatment arm within each TROP2 subgroup. |
| Other | Cell-free deoxyribonucleic acid (cfDNA) | Up to 5 years | cfDNA expression will be correlated with clinical activity of SG and bevacizumab to assess how the clinical effect of the randomized treatment is modified by cfDNA expression. Will formally test the interaction between the biomarker and the treatment assignment to assess whether this is a predictive biomarker. |
| Other | Time to first subsequent therapy or death (TFST) | From randomization to the earliest occurrence of either first subsequent therapy or death, assessed up to 5 years | TFST distributions by randomized treatment assignment in the intent to treat population will be visualized using Kaplan-Meier curves. The effect of treatment assignment on TFST will be estimated using a Cox proportional hazards model, stratified by the randomization factors. Hazard ratio estimates and 95% confidence intervals will be reported to quantify the treatment effect. Treatment effects within strata will be presented in a forest plot. |
| Other | Time to second subsequent therapy or death (TSST) | From randomization to the earliest occurrence of either second subsequent therapy or death, assessed up to 5 years | TSST distributions by randomized treatment assignment in the intent to treat population will be visualized using Kaplan-Meier curves. The effect of treatment assignment on TSST will be estimated using a Cox proportional hazards model, stratified by the randomization factors. Hazard ratio estimates and 95% confidence intervals will be reported to quantify the treatment effect. Treatment effects within strata will be presented in a forest plot. |
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/NCT07504588
GET https://conductscience.org/api/trials/v1/NCT07504588/registered