Trial Outcomes & Findings for Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas (NCT NCT06865677)
NCT ID: NCT06865677
Last Updated: 2026-01-21
Results Overview
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.
TERMINATED
PHASE2
2 participants
Up to 22 days.
2026-01-21
Participant Flow
No participants were enrolled in Arm 1/Cohort 1 - Participants with recurrent/metastatic ovarian carcinoma, and Arm 2/Cohort 2 - Participants with recurrent/metastatic endometrial carcinoma.
Participant milestones
| Measure |
Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG)
Treatment with Sacituzumab Govitecan (SG).
Sacituzumab Govitecan: 10mg/kg administered intravenous (IV) infusion on days 1 and 8 of each 21-day cycle.
|
Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG)
Treatment with Sacituzumab Govitecan (SG).
Sacituzumab Govitecan: 10mg/kg administered intravenous (IV) infusion on days 1 and 8 of each 21-day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG)
Treatment with Sacituzumab Govitecan (SG).
Sacituzumab Govitecan: 10mg/kg administered intravenous (IV) infusion on days 1 and 8 of each 21-day cycle.
|
Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG)
Treatment with Sacituzumab Govitecan (SG).
Sacituzumab Govitecan: 10mg/kg administered intravenous (IV) infusion on days 1 and 8 of each 21-day cycle.
|
|---|---|---|
|
Overall Study
Screen failure
|
1
|
0
|
|
Overall Study
Participant no longer eligible before start of conditioning
|
0
|
1
|
Baseline Characteristics
Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas
Baseline characteristics by cohort
| Measure |
Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG)
n=1 Participants
Treatment with Sacituzumab Govitecan (SG).
Sacituzumab Govitecan: 10mg/kg administered intravenous (IV) infusion on days 1 and 8 of each 21-day cycle.
|
Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG)
n=1 Participants
Treatment with Sacituzumab Govitecan (SG).
Sacituzumab Govitecan: 10mg/kg administered intravenous (IV) infusion on days 1 and 8 of each 21-day cycle.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=37 Participants
|
1 Participants
n=44 Participants
|
2 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
47 years
n=37 Participants
|
65 years
n=44 Participants
|
56 years
STANDARD_DEVIATION 12.73 • n=40 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=37 Participants
|
1 Participants
n=44 Participants
|
2 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=37 Participants
|
1 Participants
n=44 Participants
|
2 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=37 Participants
|
1 participants
n=44 Participants
|
2 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Up to 22 days.Population: This endpoint was not done. This protocol was terminated prematurely because the prior principal investigator departed the Institute without treating any participants.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 22 days.Population: This endpoint was not done. This protocol was terminated prematurely because the prior principal investigator departed the Institute without treating any participants.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 22 days.Population: This endpoint was not done. This protocol was terminated prematurely because the prior principal investigator departed the Institute without treating any participants.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 22 days.Population: This endpoint was not done. This protocol was terminated prematurely because the prior principal investigator departed the Institute without treating any participants.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 22 days.Population: This protocol was terminated prematurely because the prior principal investigator departed the Institute without treating any participants.
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.
Outcome measures
| Measure |
Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG)
n=1 Participants
Treatment with Sacituzumab Govitecan (SG).
Sacituzumab Govitecan: 10mg/kg administered intravenous (IV) infusion on days 1 and 8 of each 21-day cycle.
|
Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG)
n=1 Participants
Treatment with Sacituzumab Govitecan (SG).
Sacituzumab Govitecan: 10mg/kg administered intravenous (IV) infusion on days 1 and 8 of each 21-day cycle.
|
|---|---|---|
|
Adverse Events (AE) Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, by Type and Grade of Toxicity
|
0 Adverse events
|
0 Adverse events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 22 days.Population: This protocol was terminated prematurely because the prior principal investigator departed the Institute without treating any participants.
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.
Outcome measures
| Measure |
Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG)
n=1 Participants
Treatment with Sacituzumab Govitecan (SG).
Sacituzumab Govitecan: 10mg/kg administered intravenous (IV) infusion on days 1 and 8 of each 21-day cycle.
|
Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG)
n=1 Participants
Treatment with Sacituzumab Govitecan (SG).
Sacituzumab Govitecan: 10mg/kg administered intravenous (IV) infusion on days 1 and 8 of each 21-day cycle.
|
|---|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
|
0 Participants
|
0 Participants
|
Adverse Events
Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG)
Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place