A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma): Substudy 06C

Summary

This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluate the safety and tolerability of investigational agents with pembrolizumab and fluoropyrimidine chemotherapy for the first-line (1L) treatment of participants with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma. This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for investigational agents in combination with chemotherapy and immunotherapy. There is no formal hypothesis in this study.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Biological
  Pembrolizumab

  Administered via intravenous (IV) infusion.

• Biological
  Sacituzumab Tirumotecan (sac-TMT)

  Administered via IV infusion.

• Drug
  Capecitabine

  Administered via oral tablet.

• Drug
  Leucovorin

  Administered via IV infusion.

• Drug
  Levoleucovorin

  Administered via IV infusion.

• Drug
  5-Fluorouracil (5-FU)

  Administered via IV infusion

• Drug
  Oxaliplatin

  Administered via IV infusion

Locations (50)