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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)
1023 patients around the world
Available in Argentina, United States
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.
Merck Sharp & Dohme LLC
15Research sites
1023Patients around the world
This study is for people with
Cervical cancer
Requirements for the patient
From 18 Years
Female
Medical requirements
- 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.
- 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 (e.g., 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 (e.g., 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 assessmentsHas a history of stem cell/solid organ transplant.Has not adequately recovered from major surgery or has ongoing surgical complications.
Sites
Hospital Provincial del Centenario - Rosario, Santa Fe
Recruiting
Centro Médico Privado CEMAIC - Córdoba
Recruiting
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
Centro de Diagnóstico Investigación y Tratamiento - CEDIT - Salta
Recruiting
Fundación Respirar
Recruiting
IBCC - Núcleo de Pesquisa e Ensino
Recruiting
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Recruiting
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
StudyTroFuse-036
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Cervical cancer
Requirements
From 18 YearsFemale
Unique study IDclinicaltrials.gov
NCT07216703
