Trial · NCT06865677
Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas
NCT06865677, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2026-01-21
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas. Trials, record NCT06865677. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06865677
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas
- NCT number
- NCT06865677
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Platinum Resistant Epithelial Ovarian Carcinoma, Recurrent Epithelial Endometrial Carcinoma, Recurrent Epithelial Cervical Carcinoma
- Interventions
- Sacituzumab Govitecan, EKG, Brain MRI, CT scans, Tumor biopsy, Loperamide, Octreotide, Diphenoxylate/Atropine, Antiemetics
- First posted
- 2025-03-10
- Last updated
- 2026-01-21
- Results first posted
- 2026-01-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (Partial Response or Complete Response) of Sacituzumab Govitecan in Participants With Recurrent Gynecological Malignancies, Calculated for Each Individual Tumor Histology by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 22 days. | Overall Response Rate (the fraction of Partial Response (PR) or Complete Response (CR) will be calculated along with a 95% confidence interval for each cohort. The proportion of participants who achieve a response will be reported separately for each cohort, along with 95% confidence intervals (Clopper-Pearson). Response was assessed by the RECIST v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Median Duration of Response (DOR) of Sacituzumab Govitecan (SG) | Up to 22 days. | Duration of response (DOR) will be calculated by the Kaplan-Meier method, starting at date response was identified until progression or the response is declared to have ended, if the participants have a PR or CR. The median DOR will be reported along with a 95% confidence interval by cohort. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. |
| Secondary | Overall Survival of Participants Receiving Sacituzumab Govitecan (SG) | Up to 22 days. | Overall Survival (OS) will be calculated from on-study date until date of 10-year follow-up, using the Kaplan-Meier method by cohort. The ten-year OS rate, which is the percentage of people in a study or treatment group who are alive ten years after their initiation of the study treatment. The median OS will be reported along with a 95% confidence interval by cohort. |
| Secondary | Progression Free Survival (PFS) of Participants Receiving Sacituzumab Govitecan (SG) | Up to 22 days. | Progression Free Survival (PFS) will be calculated from on-study date until date of progression or death without progression, using the Kaplan-Meier method by cohort. The median PFS will be reported along with a 95% confidence interval by cohort. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive Disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. |
| Secondary | Adverse Events (AE) Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, by Type and Grade of Toxicity | Up to 22 days. | Safety will be reported by describing adverse events (AE) per CTCAE v5.0, by type and grade of toxicity. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Up to 22 days. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (Partial Response or Complete Response) of Sacituzumab Govitecan in Participants With Recurrent Gynecological Malignancies, Calculated for Each Individual Tumor Histology by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 22 days. | This endpoint was not done. This protocol was terminated prematurely because the prior principal investigator departed the Institute without treating any participants. | ||
| SECONDARY | Median Duration of Response (DOR) of Sacituzumab Govitecan (SG) | Up to 22 days. | This endpoint was not done. This protocol was terminated prematurely because the prior principal investigator departed the Institute without treating any participants. | ||
| SECONDARY | Overall Survival of Participants Receiving Sacituzumab Govitecan (SG) | Up to 22 days. | This endpoint was not done. This protocol was terminated prematurely because the prior principal investigator departed the Institute without treating any participants. | ||
| SECONDARY | Progression Free Survival (PFS) of Participants Receiving Sacituzumab Govitecan (SG) | Up to 22 days. | This endpoint was not done. This protocol was terminated prematurely because the prior principal investigator departed the Institute without treating any participants. | ||
| SECONDARY | Adverse Events (AE) Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, by Type and Grade of Toxicity | Up to 22 days. | This protocol was terminated prematurely because the prior principal investigator departed the Institute without treating any participants. | Adverse events | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Up to 22 days. | This protocol was terminated prematurely because the prior principal investigator departed the Institute without treating any participants. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adverse Events (AE) Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, by Type and Grade of Toxicity | Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG) | 0 | Adverse events | ||
| Adverse Events (AE) Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, by Type and Grade of Toxicity | Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG) | 0 | Adverse events | ||
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG) | 0 | Participants | ||
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG) | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG) | 1 | |
| Overall Study | STARTED | Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG) | 1 | |
| Overall Study | COMPLETED | Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG) | 0 | |
| Overall Study | COMPLETED | Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG) | 0 | |
| Overall Study | NOT COMPLETED | Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG) | 1 | |
| Overall Study | NOT COMPLETED | Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG) | 1 |
Source ClinicalTrials.gov
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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG) | 0 | 1 |
| Total, all-cause mortality | Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG) | 0 | 1 |
| Total, other adverse events | Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG) | 0 | 1 |
| Total, other adverse events | Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG) | 0 | 1 |
| Total, serious adverse events | Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG) | 0 | 1 |
| Total, serious adverse events | Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG) | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG) vs Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG): Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Trial comparisons |
| Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG) vs Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG): deaths from any cause | Trial comparisons |
| Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG) vs Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG): 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/NCT06865677
GET https://conductscience.org/api/trials/v1/NCT06865677/registered