Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas

NCT06865677 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 10002068002068-C
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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...

Conditions

Recurrent Epithelial Endometrial Carcinoma; Recurrent Epithelial Cervical Carcinoma; Recurrent Platinum Resistant Epithelial Ovarian Carcinoma

Keywords

TROP2; ADC; Gynecologic Malignancies; Relapsed

Outcome Measures

Primary Outcomes (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

  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.

  Up to 22 days.

Secondary Outcomes (4)

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

  Up to 22 days.

• Overall Survival of Participants Receiving Sacituzumab Govitecan (SG)

  Up to 22 days.

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

  Up to 22 days.

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

  Up to 22 days.

Other Outcomes (1)

• 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.

Study Arms (1)

Arm 1 -Treatment with Sacituzumab Govitecan (SG)

EXPERIMENTAL

Treatment with Sacituzumab Govitecan (SG).

Drug: Sacituzumab Govitecan; Diagnostic Test: EKG; Diagnostic Test: Brain MRI; Diagnostic Test: CT scans; Procedure: Tumor biopsy; Drug: Loperamide; Drug: Octreotide; Drug: Diphenoxylate/Atropine; Drug: Antiemetics

Interventions

Sacituzumab Govitecan DRUG

10mg/kg administered intravenous (IV) infusion on days 1 and 8 of each 21-day cycle.

Also known as: Trodelvy

Arm 1 -Treatment with Sacituzumab Govitecan (SG)

EKG DIAGNOSTIC_TEST

Screening.

Also known as: Electrocardiogram

Arm 1 -Treatment with Sacituzumab Govitecan (SG)

Brain MRI DIAGNOSTIC_TEST

Screening. Baseline/Cycle 1 Day 1 (within 14 (+3) days.

Also known as: Brain magnetic resonance imaging

Arm 1 -Treatment with Sacituzumab Govitecan (SG)

CT scans DIAGNOSTIC_TEST

Screening. Baseline/Cycle 1 Day 1 (within 14 (+3) days. Subsequent cycle 3 every 3 cycles ±7 days for the first year and then every 4 cycles ±7 days until progressive disease or up to 5 years. End of treatment assessments +14 days.

Also known as: Computed tomography scans

Arm 1 -Treatment with Sacituzumab Govitecan (SG)

Tumor biopsy PROCEDURE

Baseline/Cycle 1 Day 1≤10 days. End of treatment assessments +14 days (optional).

Also known as: Tumor bx

Arm 1 -Treatment with Sacituzumab Govitecan (SG)

Loperamide DRUG

For diarrhea. 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily.

Also known as: Immodium

Arm 1 -Treatment with Sacituzumab Govitecan (SG)

Octreotide DRUG

For diarrhea. 100-150 mcg subcutaneous (SC) three times a day if diarrhea persists.

Also known as: Sandostatin, Bynfezia, Mycapssa

Arm 1 -Treatment with Sacituzumab Govitecan (SG)

Antiemetics DRUG

For vomiting as clinically indicated.

Arm 1 -Treatment with Sacituzumab Govitecan (SG)

Diphenoxylate/Atropine DRUG

For diarrhea. 20 mg of diphenoxylate/atropine (Lomotil) administered according to package insert guidelines.

Also known as: Lomotil

Arm 1 -Treatment with Sacituzumab Govitecan (SG)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Recurrence

Interventions

sacituzumab govitecan; Electrocardiography; Tomography, X-Ray Computed; Loperamide; Octreotide; atropine sulfate-diphenoxylate hydrochloride drug combination; Antiemetics

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Gastrointestinal Agents

Results Point of Contact

• Title: Dr. Stanley Lipkowitz
• Organization: National Cancer Institute

lipkowis@navmed.nci.nih.gov

240-760-6129

Study Officials

• Kevin C Conlon, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 10, 2025
• Study Start: June 9, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: This study will comply with the National Institutes of Health (NIH) Data Management and Sharing (DMS) Policy. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
• Access Criteria: Data from this study may be requested by contacting the principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.

Locations

US (1)