Comparing a new drug to standard treatments for advanced cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of sacituzumab tirumotecan as a second-line treatment for patients with recurrent or metastatic cervical cancer. It consists of a safety run-in phase followed by a Phase 3 portion, where the new drug will be compared to physician's choice of treatment. The study aims to determine if sacituzumab tirumotecan can improve overall survival in patients with high levels of TROP2 expression. Participants must have previously received specific chemotherapy regimens and have measurable disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
* Must have recurrent or metastatic cervical cancer that has progressed on or after treatment with 1 prior line of systemic platinum doublet chemotherapy (with or without bevacizumab) AND must have received anti-PD-1/anti-PD-L1 therapy as part of prior cervical cancer regimens
* Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by the investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions
* Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent
* Has ECOG performance status of 0 or 1 within 7 days before allocation for the Sacituzumab Tirumotecan Run-in or within 7 days before randomization for the Phase 3 portion
* Has provided tumor tissue (most recent sample is preferred) from a core or excisional biopsy of a tumor lesion not previously irradiated
* HIV-infected participants must have well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Sacituzumab Tirumotecan Run-in) or randomization (Phase 3 portion)
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
* Has adequate organ function

Exclusion Criteria:

* Has Grade ≥2 peripheral neuropathy
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
* Received prior systemic anticancer therapy
* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
* Has other histological subtypes of cervical cancer apart from squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (eg, carcinosarcoma), or has a diagnosis of nonepithelial cancer (eg, sarcoma, neuroendocrine tumors) of the cervix.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Active infection requiring systemic therapy
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Concurrent active Hepatitis B and active Hepatitis C virus infection
* Severe hypersensitivity (≥Grade 3) to sacituzumab tirumotecan or treatment of physician's choice (TPC) and/or any of their excipients, or other biologic therapy
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications
* Has a history of (noninfectious) pneumonitis/ILD that required steroids or has current pneumonitis/ILD

Where it's running

• USA Mitchell Cancer Institute-Clinical Trials ( Site 4126)
  Mobile, Alabama, United States Recruiting
• Providence Alaska Medical Center ( Site 4137)
  Anchorage, Alaska, United States Recruiting
• HonorHealth (HH) ( Site 8002)
  Phoenix, Arizona, United States Recruiting
• Moores Cancer Center-Clinical Trials Office - Gynecological Oncology ( Site 4125)
  La Jolla, California, United States Recruiting
• UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4105)
  Los Angeles, California, United States Recruiting
• Hoag Memorial Hospital Presbyterian ( Site 4104)
  Newport Beach, California, United States Recruiting

+190 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sacituzumab tirumotecan plus QL1706 for recurrent or metastatic cervical cancer

  This study will test whether combining sacituzumab tirumotecan (a TROP2-targeted antibody‑drug conjugate) with QL1706 (a dual PD‑1/CTLA‑4 antibody) helps people with recurrent or metastatic cervical cancer who have already received platinum therapy.

  Recruiting at 2 sites Phase 2 Fujian Cancer Hospital · Fuzhou, Fujian and 13 other locations · NCT07256236

• Sacituzumab tirumotecan plus pembrolizumab as first-line maintenance for metastatic cervical cancer

  This trial tests whether adding the antibody-drug conjugate sacituzumab tirumotecan to pembrolizumab (with or without bevacizumab) as maintenance treatment can help people with metastatic cervical cancer live longer or keep the cancer from growing.

  Recruiting at 191 sites Phase 3 Merck Sharp & Dohme LLC · Birmingham, Alabama and 190 other locations · NCT07216703

• Treatment for recurrent or persistent cervical cancer using sacituzumab govitecan

  This study is testing a new treatment called sacituzumab govitecan to see if it can help people with recurrent or persistent cervical cancer who have already tried chemotherapy.

  Recruiting at 2 sites Phase 2 Yale University · New Haven, Connecticut and 1 other locations · NCT05838521

• Cervical screening and care options for women living with HIV who test positive for high-risk HPV

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  Recruiting University of California, San Diego · Nairobi · NCT07925307

• Hydrogel spacer to protect the rectum during cervical cancer radiotherapy

  This study tests whether placing an absorbable hydrogel spacer between the cervix/vagina and rectum before definitive radiotherapy can reduce rectal radiation exposure for women with cervical cancer.

  Recruiting Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07904182

• How cinema sessions during chemotherapy might help cervical cancer patients

  We’re testing if watching films during chemotherapy helps cervical cancer patients feel less anxious and improve quality of life.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma · NCT07902180

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.