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

NCT06445972 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Gastroesophageal Junction
  • Gastroesophageal Adenocarcinoma
  • Esophageal Neoplasms
  • Esophageal Cancer

Interventions

BIOLOGICAL

Ramucirumab

8 mg/kg IV Infusion

DRUG

Paclitaxel

80 mg/M\^2 IV infusion

BIOLOGICAL

Sacituzumab Tirumotecan

3 mg/kg or 4 mg/kg IV Infusion

DRUG

Rescue Medications

Participants receive rescue medications according to each approved drug's product label. Recommended rescue medications for the Sacituzumab Tirumotecan + Paclitaxel arm include antihistamines (histamine-1 and histamine-2 receptor antagonists), acetaminophen or equivalent, dexamethasone or equivalent infusion, and steroid mouth wash (dexamethasone or equivalent) and rescue medications for the HER3-DXd + ramucirumab arm include 5-HT3-receptor antagonist, NK-1 receptor antagonist, and corticosteroids.

BIOLOGICAL

HER3-DXd

IV Infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-07
Primary Completion
2028-05-09
Completion
2030-08-08
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Chile
  • China
  • France
  • Germany
  • Italy
  • Norway
  • South Korea
  • Switzerland
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06445972 on ClinicalTrials.gov