Sacituzumab Govitecan for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

Overseen byJung-Min Lee, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Jung-Min Lee, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This trial is for adults over 18 with ovarian, endometrial, or cervical cancer that has returned after at least two standard treatments. Participants must have completed prior therapies and be able to provide tissue samples from their tumors.

Inclusion Criteria

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, age >= 18 years, ECOG performance status <= 1, and adequate organ and marrow function as specified in the criteria. Participants with suspicion or prior history of treated CNS metastases with no active disease are eligible. Various washout periods for prior therapies are required. Specific requirements for HIV, HBV, and HCV infected participants. IOCBP requirements for contraception and pregnancy testing. Nursing participants requirements. Ability to understand and sign informed consent.

I have recurrent ovarian cancer that is resistant to platinum-based treatments.

I have endometrial cancer that hasn't responded to standard treatments and have tried or can't try anti-PD-1/PD-L1 therapy.

See 1 more

Exclusion Criteria

Participants who are receiving any other investigational agents

My ovarian cancer did not respond to initial platinum-based chemotherapy.

I have a history of serious GI or lung-related issues.

See 9 more

Treatment Details

Interventions

Sacituzumab Govitecan (Monoclonal Antibodies)

Trial OverviewThe trial is testing Sacituzumab Govitecan (SG), a drug approved for other cancers, on those with relapsed ovarian, endometrial, or cervical cancers. Patients will receive SG infusions in cycles of 21 days for up to five years if beneficial.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention

Treatment with sacituzumab govitecan (SG)