Sacituzumab tirumotecan plus pembrolizumab as first-line maintenance for metastatic 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 is a two-part, randomized Phase 3 trial with an initial safety run-in where participants receive sacituzumab tirumotecan, pembrolizumab, and bevacizumab. In the main randomized phase, all participants first receive standard induction therapy; those whose disease does not progress are randomized to maintenance treatment with pembrolizumab alone or sacituzumab tirumotecan plus pembrolizumab, with bevacizumab allowed at the investigator's discretion. The study will track safety, overall survival, and progression-free survival to compare the maintenance strategies. Treatment involves regular infusions and scheduled clinical and imaging follow-up to monitor response and side effects.

Why it matters

Who can join: the full rules

The main inclusion criteria include but are not limited to the following:

* Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix
* Has persistent, recurrent, or newly diagnosed metastatic (International Federation of Gynecology and Obstetrics \[FIGO\]-2018 Stage IVB) cervical cancer that is not amenable to curative treatment (surgery and/or radiation)
* If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy
* If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load
* If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
* Has an Eastern Cooperative Oncology Group performance status of 0 or 1
* Has tumor programmed cell death ligand 1 expression of combined positive score ≥1

The main exclusion criteria include but are not limited to the following:

* Has HIV infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has a 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
* Has received prior systemic anticancer therapy other than what is specified in this protocol
* Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT
* Has a diagnosis of immunodeficiency
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system metastases and/or carcinomatous meningitis
* Has active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
* Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments
* Has a history of stem cell/solid organ transplant
* Has not adequately recovered from major surgery or has ongoing surgical complications

Where it's running

• University of Alabama- Birmingham ( Site 5015)
  Birmingham, Alabama, United States Recruiting
• Alaska Womens Cancer Care ( Site 5046)
  Anchorage, Alaska, United States Recruiting
• CHAO Family Comprehensive Cancer Center and Ambulatory Care ( Site 5037)
  Irvine, California, United States Recruiting
• Moores Cancer Center-Clinical Trials Office - Gynecological Oncology ( Site 5000)
  La Jolla, California, United States Recruiting
• University of California Irvine Medical Center ( Site 6006)
  Orange, California, United States Recruiting
• Florida Cancer Specialists - South ( Site 7001)
  Fort Myers, Florida, United States Recruiting

+141 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.

• BL-B01D1 plus pembrolizumab, with or without bevacizumab, for recurrent or metastatic cervical and endometrial cancer

  This trial will try a combination of BL-B01D1 and pembrolizumab, with or without bevacizumab, in adults with recurrent or metastatic cervical or endometrial cancer to see if it shrinks tumors or controls the disease.

  Recruiting Phase 2 Sichuan Baili Pharmaceutical Co., Ltd. · Shanghai, Shanghai Municipality · NCT07054567

• Sacituzumab Tirumotecan plus Pembrolizumab in advanced biliary tract cancer

  This study tests whether the combination of Sacituzumab Tirumotecan and Pembrolizumab can help people with advanced biliary tract cancer who have already had at least one approved therapy fail.

  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07850791

• Sac-TMT and pembrolizumab with chemoradiation for bladder muscle invasion

  This trial tests whether adding Sac-TMT and pembrolizumab to chemoradiation helps people with muscle-invasive bladder cancer live longer without the cancer growing or returning.

  Recruiting at 10 sites Phase 3 Merck Sharp & Dohme LLC · Kaohsiung City and 9 other locations · NCT07829783

• Sacituzumab tirumotecan with or without pembrolizumab in ovarian clear cell cancer that has come back or spread

  This phase II study tests Sacituzumab tirumotecan alone or with pembrolizumab in adults whose ovarian clear cell cancer has recurred or spread after prior PD-1 therapy.

  Recruiting Phase 2 Tufts Medical Center · Boston, Massachusetts · NCT07718854

• Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer

  This registry follows people with persistent, recurrent, or metastatic cervical cancer who are treated with pembrolizumab-containing regimens to see how well it works in real-world care.

  Recruiting at 3 sites Phase 4 University Medical Center Groningen · Amsterdam and 10 other locations · NCT07645625

• Sac-TMT plus bevacizumab in TNBC with brain metastases

  This phase II, single-arm study tests whether Sac-TMT combined with bevacizumab can help people with triple-negative breast cancer and brain metastases.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT07623577

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.