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)
Cervical Cancer
Unknown Primary
18 Years and older, Male and Female
2870-036 (primary)
NCI-2026-02021
2025
2025-521514-26-00
ENGOT-cx22
GOG-3123
jRCT2031250604
MK-2870-036
TroFuse-036
U1111-1319-9926
Summary
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
Objectives
This is a 2-part study.
In Part 1 Safety Run-in, eligible participants will be allocated to treatment with
sac-TMT + pembrolizumab + bevacizumab.
In Part 2, all participants receive standard of care induction treatment. Eligible
participants whose cancer does not progress then begin maintenance treatment and are
randomized to receive pembrolizumab or sac-TMT + pembrolizumab. All participants in Part
2 maintenance treatment may also receive bevacizumab at the investigator's discretion.
Eligibility
- 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
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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