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New treatment option for Cervical Cancer
Official title 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)
ClinicalTrials.gov ID: NCT07216703
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cervical cancer.
Also referred to as Keytruda®, MK-3475.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- The main 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...
- 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
You likely can't join if
- 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...
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease...
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has received prior systemic anticancer therapy other than what is specified in this protocol
See the full eligibility criteria
- The main 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
- 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...
- Has a history of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
The study team makes the final eligibility decision.
Where it's taking place
- Miami Beach, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Savannah, Georgia, United States
- Shreveport, Louisiana, United States
- Edina, Minnesota, United States
- Las Vegas, Nevada, United States
- New York, New York, United States
- Tulsa, Oklahoma, United States
- Eugene, Oregon, United States
- Providence, Rhode Island, United States
- Knoxville, Tennessee, United States
- Fort Worth, Texas, United States
- The Woodlands, Texas, United States
- Tyler, Texas, United States
- Charlottesville, Virginia, United States
- Berazategui, Buenos Aires, Argentina
- Mar del Plata, Buenos Aires, Argentina
- Belgrano, Buenos Aires F.D., Argentina
- Posadas, Misiones Province, Argentina
+ 113 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami Beach, Florida, United States; West Palm Beach, Florida, United States; Atlanta, Georgia, United States; Savannah, Georgia, United States; Shreveport, Louisiana, United States; Edina, Minnesota, United States and 127 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.