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A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)

Status
Active
Cancer Type
Esophogeal Cancer
Stomach/ Gastric Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06356311
Protocol IDs
2870-015 (primary)
NCI-2024-06314
2023-505423-31
2023-505423-31-00
jRCT2031240133
MK-2870-015
U1111-1291-7109
Study Sponsor
Merck Sharp and Dohme LLC

Summary

This study will compare how safe and effective sacituzumab tirumotecan is versus the
treatment of physician's choice (TPC) in participants with advanced/metastatic
gastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumab
tirumotecan is superior to TPC with respect to Overall Survival (OS).

Eligibility

  1. Has a histologically-or cytologically-confirmed diagnosis of advanced, unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma
  2. Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology. Lesions situated in a previously-irradiated area are considered measurable if progression has been shown in such lesions.
  3. Has received, and progressed on, at least 2 prior chemotherapy and/or immunotherapy regimens for advanced, unresectable or metastatic gastroesophageal adenocarcinoma.
  4. Participants are eligible regardless of human epidermal growth factor receptor-2 (HER2) status. Participants who are HER2+ must have previously received trastuzumab where available/appropriate
  5. Has adequate organ function
  6. Has provided tumor tissue sample for determination of trophoblast cell-surface antigen 2 (TROP2) status by the central laboratory before randomization for stratification
  7. Participants who have AEs due to previous anticancer therapies must have recovered to Grade =1 or baseline (except for alopecia and vitiligo). Participants with endocrine related AEs who are adequately treated with hormone replacement therapy are eligible
  8. Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by the local site investigator/radiology
  9. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days before randomization
  10. Has ability to swallow oral medication for those who may receive trifluridine-tipiracil
  11. Human immunodeficiency virus (HIV) infected participants must have well-controlled HIV on antiretroviral therapy (ART)
  12. Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
  13. Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
**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... Click here to learn more about clinical trials.