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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas

NCTNCT06865677 (opens ClinicalTrials.gov in a new tab)Other id10002068Other id002068-C

Overview

Status
Terminated
Phase
Phase 2
Enrollment
2 participants (actual)
Sponsor
National Cancer Institute (NCI) · Nih
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
9 Jun 2025
Primary completion
1 Jul 2025
Completion
1 Jul 2025
First posted
10 Mar 2025
Last update posted
21 Jan 2026
Conditions
Recurrent Platinum Resistant Epithelial Ovarian Carcinoma · Recurrent Epithelial Endometrial Carcinoma · Recurrent Epithelial Cervical Carcinoma

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026
  1. Ph 2

    Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas

    NCT06865677

    9 Jun 2025 to 1 Jul 2025

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Background: Cancers of the female reproductive organs often come back after treatment. A drug called sacituzumab govitecan (SG) has been approved for use in other types of cancers. Researchers want to see if SG can also help people with ovarian, endometrial, or cervical cancers. Objective: To test SG in people with ovarian, endometrial, or cervical cancers. Eligibility: People aged 18 years and older with ovarian, endometrial, or cervical cancer. Their cancers must have returned after at least 2 rounds of standard treatments. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and a test of their heart function. They also will have biopsies to get new tissues samples taken from their tumors. SG is infused through a tube attached to a needle inserted into a vein in the arm. Treatment will be given in 21-day cycles. Participants will receive SG on days 1 and 8 of each cycle. Each infusion takes 1 to 3 hours. Participants may receive SG for up to 5 years. They can continue as long as the drug is helping them. Imaging scans and other tests will be repeated throughout the study period. Participants will have an end-of-treatment visit within 2 weeks and a safety visit about 30 days after they stop treatment. Physical exams, blood tests, and imaging scans may be repeated. Participants will then be contacted by phone every 6 months for up to 10 years after their first dose of SG. Sponsoring Institution: National Cancer Institute...

Interventions

  • Sacituzumab GovitecanDrug
  • EKGDiagnostic test
  • Brain MRIDiagnostic test
  • CT scansDiagnostic test
  • Tumor biopsyProcedure
  • LoperamideDrug
  • OctreotideDrug
  • Diphenoxylate/AtropineDrug
  • AntiemeticsDrug

Arms1

  • Experimental

    Arm 1 -Treatment with Sacituzumab Govitecan (SG)

    Treatment with Sacituzumab Govitecan (SG).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Time frame · Up to 22 days.

    Registry description

    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 outcomes(4)
  1. Median Duration of Response (DOR) of Sacituzumab Govitecan (SG)

    Time frame · Up to 22 days.

    Registry description

    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.

  2. Overall Survival of Participants Receiving Sacituzumab Govitecan (SG)

    Time frame · Up to 22 days.

    Registry description

    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.

  3. Progression Free Survival (PFS) of Participants Receiving Sacituzumab Govitecan (SG)

    Time frame · Up to 22 days.

    Registry description

    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.

  4. Adverse Events (AE) Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, by Type and Grade of Toxicity

    Time frame · Up to 22 days.

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· Up to 22 days.

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

GroupValue
Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG)not posted
Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG)not posted
Secondary and other outcome results(5)
Secondary outcome· Up to 22 days.

Median Duration of Response (DOR) of Sacituzumab Govitecan (SG)

GroupValue
Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG)not posted
Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG)not posted
Secondary outcome· Up to 22 days.

Overall Survival of Participants Receiving Sacituzumab Govitecan (SG)

GroupValue
Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG)not posted
Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG)not posted
Secondary outcome· Up to 22 days.

Progression Free Survival (PFS) of Participants Receiving Sacituzumab Govitecan (SG)

GroupValue
Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG)not posted
Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG)not posted
Secondary outcomeNumber· Up to 22 days.

Adverse Events (AE) Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, by Type and Grade of Toxicity

GroupValue (Adverse events)
Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG)0
Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG)0
Other pre specified outcomeCount of participants· Up to 22 days.

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

GroupValue (Participants)
Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG)0
Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG)0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
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.0 / 10 / 10 / 1
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.0 / 10 / 10 / 1

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 120 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
* INCLUSION CRITERIA: Cohort 1 (Ovarian Cancer) * Participants must have histologically or cytologically confirmed recurrent platinum-resistant (defined as less than six months of platinum-free interval) epithelial (i.e., high grade serous, endometrioid, low grade serous, or clear cell) ovarian carcinoma that is refractory to standard treatment. * Participants with known BReast CAncer gene (BRCA) mutated tumors should have received a poly(ADP-ribose) polymerase (PARP) inhibitor maintenance or treatment. * Participants without known BRCA mutation and platinum-resistant tumors must have had prior bevacizumab or not eligible for bevacizumab-based therapy (i.e., history of proteinuria). Cohort 2 (Endometrial Cancer) * Participants must have histologically or cytologically confirmed recurrent epithelial (i.e., endometrioid or serous) endometrial carcinoma that is refractory to standard treatment. * Participants must have received prior anti-programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1)-based therapy or not eligible for anti-PD-1/PD-L1-based therapy. Cohort 3 (Cervical Cancer) -Participants must have histologically or cytologically confirmed recurrent epithelial cervical (i.e. squamous or adeno) carcinoma that is refractory to standard treatment. Note: Participants with a history of human papilloma virus infection (i.e., positive human papillomavirus (HPV deoxyribonucleic acid (DNA testing) are eligible. -Participants must have received prior bevacizumab-based therapy or not eligible for bevacizumab-based therapy (i.e., history of proteinuria). Note: Platinum chemotherapy administered concurrent with primary radiation (i.e., weekly cisplatin) is not counted as a systemic chemotherapeutic regimen for management of persistent or recurrent carcinoma of the cervix. All Cohorts * Participants must have received at least two systemic therapies including at least one platinum-based therapy regimen. * Participants must have radiographically measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and safely biopsiable lesion. * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status \<= 1 * Adequate organ and marrow function as defined below: * Hemoglobin (Hgb) \>= 9.0 g/dL * Absolute neutrophil count (ANC) \>= 1,500/mcL * Platelets \>= 100,000/mcL * White Blood Cell count (WBC) \>= 3,000/mcL * Total bilirubin \<= 1.5 x upper limit of normal (ULN) (\<= 3 x ULN in participants with known/suspected Gilbert's disease) * Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) \<= 2.5 x ULN * Serum creatinine \<= 1.5 x ULN or estimated glomerular filtration rate (GFR) \>= 30 ml/min/1.73 m\^2 * Participants with suspicion or prior history of treated central nervous system (CNS) metastases with no evidence of active disease (assessed by magnetic resonance imaging (MRI) or contrast computed tomography (CT) scan of the brain and spinal column) are eligible if pretreatment brain MRI demonstrate no evidence of disease in the past 4 weeks prior to entry. * Major surgical procedure, other than for diagnosis, must not occur within 4 weeks prior to the first dose of study treatment. Participants must have recovered adequately from the toxicity and/or complications from the intervention prior to starting the study drug. * Participants with prior cancer-directed therapy must have a washout period of 3 weeks prior to the first dose of study treatment. * Participants with prior cancer-directed immunotherapy-based therapy must have a washout period of 4 weeks prior to the first dose of study treatment. * Human immunodeficiency virus (HIV)-infected participants are eligible if on stable dose of highly active antiretroviral therapy (HAART), a cluster of differentiation 4 (CD4) count \>= 200 cells/mcL, and an undetectable viral load (VL). * Hepatitis B virus (HBV) positive participants are eligible if they have been treated or are on an appropriate course of antivirals at study entry. * Participants with a history of hepatitis C virus (HCV) infection (i.e., positive HCV antibody test) must have been treated and cured (undetectable HCV VL at screening). Participants with HCV infection who are currently on treatment are eligible if they have an undetectable HCV VL. * Individuals of child-bearing potential (IOCBP) must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) prior to study entry, for the duration of study participation, and for at least 6 months after the last dose of study drug. * IOCBP must undergo pregnancy testing at screening and must not be pregnant in order to take part. Note: In these cases, a negative Beta-human chorionic gonadotropin (Beta-human chorionic gonadotropin (hCG) (urine or blood) is required. * Nursing participants must discontinue nursing and/or not begin nursing until 1 month after the last dose of study drug. * Ability of participants to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * Participants who are receiving any other investigational agents * Primary platinum-refractory ovarian cancer (defined as progression while on the upfront platinum-based therapy) * Participants with any other concomitant invasive malignancies * History of severe hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to sacituzumab govitecan (SG), Camptosar; irinotecan; 7-ethyl-10-{4-\[1-piperidino\]-1-piperidino}carbonyoxycamptothecin (SN-38), or irinotecan. * Prior treatment with trophoblast cell-surface marker (TROP2)-targeting antibody drug conjugates (ADC). Participants with prior use of other ADCs are eligible. * Prior treatment with topoisomerase 1 inhibitors i.e., topotecan * Symptomatic or untreated brain/central nervous system (CNS) metastases * Participants who require treatment with uridine diphosphate glucuronosyltransferase (UGT1A1) inhibitors. * Participants with known homozygous UGT1A1\*28 allele if tested during the previous treatment. * Participants with active infection requiring antibiotics. * Participants who have not recovered from toxicities or adverse events (AE) related to prior therapy to Grade \<= 1 with the following exceptions. * Participants with platinum related hypomagnesemia (on replacement) are eligible. * Participants with auto-immune thyroid dysfunction on stable replacement therapy are eligible. * Participants with any grade alopecia or grade 1 or 2 neuropathy are eligible. * Participants with a history of gastrointestinal (GI) perforation or hemorrhage (\> 30mL bleeding/episode) fistula or hemoptysis within 3 months prior to initiation of study therapy, intra-abdominal abscess in the 6 months prior to entry, history of ascites or pleural effusion requiring paracentesis or thoracentesis in the 4 weeks prior to initiation of study therapy or history of bowel obstruction within 3 months prior to initiation of study therapy. * Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during SG treatment or within 5 months after the final dose of SG. Note: Seasonal flu vaccines that do not contain a live virus and locally authorized/approved Coronavirus disease 2019 (COVID-19) vaccines are permitted * Participants with severe uncontrolled intercurrent illness that would limit compliance with study requirements, evaluated by history, physical exam, and chemistry panel.

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