Recruiting INTERVENTIONAL NCT06445972

Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)

A Phase 1/2 Open-Label, Umbrella Platform Design Study to Evaluate the Safety and Efficacy of Investigational Agents in Combination With Standard of Care Treatments as the Second-Line Treatment of Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma: Substudy 06D

Sponsor: Daiichi Sankyo

Conditions Esophageal Cancer Esophageal Neoplasms Gastroesophageal Adenocarcinoma Gastroesophageal Junction

Interventions HER3-DXd Paclitaxel Ramucirumab Rescue Medications Sacituzumab Tirumotecan

Updated 22 times since 2024 Last updated: Apr 29, 2026 Started: Aug 7, 2024 Primary completion: May 9, 2028 Completion: Aug 8, 2030

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Esophageal Cancer and Esophageal Neoplasms, this trial is actively recruiting participants. The trial is conducted by Daiichi Sankyo and has accumulated 22 data snapshots since 2024. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

This is a substudy of the master protocol MK-3475-U06 (KEYMAKER-U06).

Status Flow

Change History

22 versions recorded

May 4, 2026 — Present [daily]

Recruiting

Phase: PHASE1/PHASE2 → None
Mar 2026 — May 2026 [monthly]

Recruiting PHASE1/PHASE2
Feb 2026 — Mar 2026 [monthly]

Recruiting PHASE1/PHASE2
Jan 2026 — Feb 2026 [monthly]

Recruiting PHASE1/PHASE2
Dec 2025 — Jan 2026 [monthly]

Recruiting PHASE1/PHASE2

▶ Show 17 earlier versions

Nov 2025 — Dec 2025 [monthly]

Recruiting PHASE1/PHASE2
Oct 2025 — Nov 2025 [monthly]

Recruiting PHASE1/PHASE2
Sep 2025 — Oct 2025 [monthly]

Recruiting PHASE1/PHASE2
Aug 2025 — Sep 2025 [monthly]

Recruiting PHASE1/PHASE2
Jul 2025 — Aug 2025 [monthly]

Recruiting PHASE1/PHASE2
Jun 2025 — Jul 2025 [monthly]

Recruiting PHASE1/PHASE2
May 2025 — Jun 2025 [monthly]

Recruiting PHASE1/PHASE2
Apr 2025 — May 2025 [monthly]

Recruiting PHASE1/PHASE2
Mar 2025 — Apr 2025 [monthly]

Recruiting PHASE1/PHASE2
Feb 2025 — Mar 2025 [monthly]

Recruiting PHASE1/PHASE2
Jan 2025 — Feb 2025 [monthly]

Recruiting PHASE1/PHASE2
Dec 2024 — Jan 2025 [monthly]

Recruiting PHASE1/PHASE2
Nov 2024 — Dec 2024 [monthly]

Recruiting PHASE1/PHASE2
Oct 2024 — Nov 2024 [monthly]

Recruiting PHASE1/PHASE2
Sep 2024 — Oct 2024 [monthly]

Recruiting PHASE1/PHASE2
Aug 2024 — Sep 2024 [monthly]

Recruiting PHASE1/PHASE2

Status: Not Yet Recruiting → Recruiting
Jul 2024 — Aug 2024 [monthly]

Not Yet Recruiting PHASE1/PHASE2

First recorded

Eligibility Summary

This is a phase 1/2 multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of sacituzumab tirumotecan (MK-2870) plus paclitaxel versus ramucirumab plus paclitaxel, and HER3-DXD plus ramucirumab versus ramucirumab plus paclitaxel for the treatment of participants with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma who have failed 1 prior line of therapy. This is an estimation study, and no formal hypothesis testing will be performed.

Contact Information

Sponsor contact:

Daiichi Sankyo
Merck Sharp & Dohme LLC

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Antofagasta, Chile , Beijing, China , Brest, France , Chur, Switzerland , Düsseldorf, Germany , East Syracuse, United States , Fuzhou, China , Geneva, Switzerland , Grand Rapids, United States , Hamburg, Germany and 34 more locations