Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas

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

Interventions

DRUG

Sacituzumab Govitecan

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

DIAGNOSTIC_TEST

EKG

Screening.

DIAGNOSTIC_TEST

Brain MRI

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

DIAGNOSTIC_TEST

CT scans

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.

PROCEDURE

Tumor biopsy

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

DRUG

Loperamide

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

DRUG

Octreotide

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

DRUG

Diphenoxylate/Atropine

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

DRUG

Antiemetics

For vomiting as clinically indicated.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Kevin C Conlon, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-09

Primary Completion

2025-07-01

Completion

2025-07-01

FDA Drug

Yes

Countries

• United States

Study Locations