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A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)

Status
Active
Cancer Type
Cervical Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Female
Study Type
Treatment
NCT ID
NCT06459180
Protocol IDs
2870-020 (primary)
NCI-2024-09277
2023-508323-12
ENGOT-cx20
GOG-3101
jRCT2031240201
MK-2870-020
TroFuse-020
U1111-1298-0563
Study Sponsor
Merck Sharp & Dohme LLC

Summary

This study will have two phases: a sacituzumab tirumotecan safety run-in and a Phase 3
portion. The safety run-in phase will be used to evaluate the efficacy and safety of
sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion. The purpose of
this study is to compare the efficacy and safety of sacituzumab tirumotecan versus
treatment of physician's choice as second-line treatment for participants with recurrent
or metastatic cervical cancer in the Phase 3 portion.

The primary study hypotheses are that, in the Phase 3 portion, sacituzumab tirumotecan
results in a superior overall survival compared to TPC in participants with high
trophoblast cell surface antigen 2 (TROP2) expression level and in all participants.

Eligibility

  1. Has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
  2. Must have recurrent or metastatic cervical cancer that has progressed on or after treatment with 1 prior line of systemic platinum doublet chemotherapy (with or without bevacizumab) AND must have received anti-PD-1/anti-PD-L1 therapy as part of prior cervical cancer regimens
  3. Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by the investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions
  4. Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent
  5. Has ECOG performance status of 0 or 1 within 7 days before allocation for the Sacituzumab Tirumotecan Run-in or within 7 days before randomization for the Phase 3 portion
  6. Has provided tumor tissue (most recent sample is preferred) from a core or excisional biopsy of a tumor lesion not previously irradiated
  7. HIV-infected participants must have well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART)
  8. Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Sacituzumab Tirumotecan Run-in) or randomization (Phase 3 portion)
  9. Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
  10. Has adequate organ function

Treatment Sites in Georgia

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