RECRUITING

Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas

Talk to us

Conditions

Recurrent Platinum Resistant Epithelial Ovarian CarcinomaRecurrent Epithelial Endometrial CarcinomaRecurrent Epithelial Cervical CarcinomaTROP2ADCGynecologic MalignanciesRelapsed

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Phase II Pilot Study of Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas

Quick Facts

Study Start:2025-06-09
Study Completion:2027-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06865677

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Participants with known BRCA mutated tumors should have received a PARP inhibitor maintenance or treatment.
  3. * 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).
  4. * Participants must have histologically or cytologically confirmed recurrent epithelial (i.e., endometrioid or serous) endometrial carcinoma that is refractory to standard treatment.
  5. * Participants must have received prior anti-PD-1/PD-L1-based therapy or not eligible for anti-PD-1/PD-L1-based therapy.
  6. * Participants must have received at least two systemic therapies including at least one platinum-based therapy regimen.
  7. * Participants must have radiographically measurable disease, per RECIST 1.1, and safely biopsiable lesion.
  8. * Age \>= 18 years
  9. * ECOG performance status \<= 1
  10. * Adequate organ and marrow function as defined below:
  11. * Hemoglobin (Hgb) \>= 9.0 g/dL
  12. * Absolute neutrophil count (ANC) \>= 1,500/mcL
  13. * Platelets \>= 100,000/mcL
  14. * White Blood Cell count (WBC) \>= 3,000/mcL
  15. * Total bilirubin \<= 1.5 x upper limit of normal (ULN) (\<= 3 x ULN in participants with known/suspected Gilbert s disease)
  16. * Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) \<= 2.5 x ULN
  17. * Serum creatinine \<= 1.5 x ULN or estimated GFR \>= 30 ml/min/1.73 m\^2
  18. * Participants with suspicion or prior history of treated central nervous system (CNS) metastases with no evidence of active disease (assessed by MRI or contrast 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.
  19. * 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.
  20. * Participants with prior cancer-directed therapy must have a washout period of 3 weeks prior to the first dose of study treatment.
  21. * Participants with prior cancer-directed immunotherapy-based therapy must have a washout period of 4 weeks prior to the first dose of study treatment.
  22. * Human immunodeficiency virus (HIV)-infected participants are eligible if on stable dose of highly active antiretroviral therapy (HAART), a CD4 count \>= 200 cells/mcL, and an undetectable viral load (VL).
  23. * Hepatitis B virus (HBV) positive participants are eligible if they have been treated or are on an appropriate course of antivirals at study entry.
  24. * 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.
  25. * 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.
  26. * 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-hCG) (urine or blood) is required.
  27. * Nursing participants must discontinue nursing and/or not begin nursing until 1 month after the last dose of study drug.
  28. * Ability of participants to understand and the willingness to sign a written informed consent document.
  1. * Participants who are receiving any other investigational agents
  2. * Primary platinum-refractory ovarian cancer (defined as progression while on the upfront platinum-based therapy)
  3. * Participants with any other concomitant invasive malignancies
  4. * History of severe hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to SG, SN-38, or irinotecan.
  5. * Prior treatment with TROP2-targeting ADC. Participants with prior use of other ADCs are eligible.
  6. * Prior treatment with topoisomerase 1 inhibitors i.e., topotecan
  7. * Symptomatic or untreated brain/CNS metastases
  8. * Participants who require treatment with UGT1A1 inhibitors.
  9. * Participants with known homozygous UGT1A1\*28 allele if tested during the previous treatment.
  10. * Participants with active infection requiring antibiotics.
  11. * Participants who have not recovered from toxicities or AEs related to prior therapy to Grade \<= 1 with the following exceptions.
  12. * Participants with platinum related hypomagnesemia (on replacement) are eligible.
  13. * Participants with auto-immune thyroid dysfunction on stable replacement therapy are eligible.
  14. * Participants with any grade alopecia or grade 1 or 2 neuropathy are eligible.
  15. * 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.
  16. * 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 COVID-19 vaccines are permitted
  17. * Participants with severe uncontrolled intercurrent illness that would limit compliance with study requirements, evaluated by history, physical exam, and chemistry panel.

Contacts and Locations

Study Contact

Valentina Bolanos, R.N.
CONTACT
(240) 858-7666
valentina.bolanos@nih.gov
Jung-Min Lee, M.D.
CONTACT
(240) 760-6128
leej6@mail.nih.gov

Principal Investigator

Jung-Min Lee, M.D.
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Jung-Min Lee, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-09
Study Completion Date2027-12-30

Study Record Updates

Study Start Date2025-06-09
Study Completion Date2027-12-30

Terms related to this study

Keywords Provided by Researchers

  • TROP2
  • ADC
  • Gynecologic Malignancies
  • Relapsed

Additional Relevant MeSH Terms

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