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RecruitingPhase 3

A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests sacituzumab tirumotecan (sac-TMT) with pembrolizumab, with or without bevacizumab, for cervical cancer that has spread. It is for people whose cancer cannot be cured with surgery or radiation. Researchers will check safety and whether treatment helps people live longer or keeps cancer from getting worse compared with standard treatment.

Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body. Researchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and * If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A tissue test shows one of these cervical cancer types: squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma.
  • The cancer has not gone away, has come back, or is newly found and has spread far from the cervix. Surgery or radiation cannot cure it.
  • If you have HIV, it is well controlled with HIV medicines.
  • If you test positive for hepatitis B surface antigen, you have received treatment, and blood tests cannot detect the virus.
  • If you have had hepatitis C, blood tests cannot detect the virus.
  • You can do all usual activities or have limits only with hard physical activity.
  • Your tumor has a PD-L1 test score of at least 1. PD-L1 is a protein that can help cancer hide from the immune system.

Who can't join

  • You have HIV and have had Kaposi's sarcoma or multicentric Castleman's disease, which affect blood vessels or immune cells.
  • You have had severe dry eyes, eyelid or eyelid oil-gland disease, or disease that slows healing of the eye's clear outer layer.
  • You have or have had inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or chronic diarrhea.
  • You have serious, uncontrolled heart or blood vessel disease, including blood vessel disease in the brain.
  • You have had cancer medicine not allowed by the study, or take a medicine that strongly affects the CYP3A4 enzyme and cannot be stopped during sac-TMT treatment.
  • You have a weak immune system, have had a stem cell or organ transplant, or have an autoimmune disease that needed whole-body treatment in the past 2 years. Hormone replacement, such as insulin or thyroid medicine, is allowed.
  • You have another cancer that is growing or needed treatment in the past 3 years, or active cancer spread to the brain, spinal cord, or their lining.
  • You have current or suspected lung inflammation or scarring, have had lung inflammation not caused by infection that needed steroids, or have not healed enough after major surgery or still have surgery-related problems.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 \[FIGO\]-2028 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

Study sites (30)

AK

AL

CA

FL

GA

LA

MD

MN

NV

NY

OH

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6002) · Columbus, OH 43210Study Coordinator · Study contact · 800-293-5066More trials in Columbus

OK

OR

  • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007) · Eugene, OR 97401Study Coordinator · Study contact · 541-683-5001More trials in Eugene

PA

RI

TN

TX

VA