Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)
Public ClinicalTrials.gov record NCT06445972. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06445972
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 210 participants
Conditions and interventions
Conditions
Interventions
- Ramucirumab Biological
- Paclitaxel Drug
- Sacituzumab Tirumotecan Biological
- Rescue Medications Drug
- HER3-DXd Biological
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 6, 2024
- Primary completion
- May 8, 2028
- Completion
- Aug 7, 2030
- Last update posted
- Jul 23, 2026
2024 – 2030
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 8927) | Tucson | Arizona | 85719 | Recruiting |
| UCLA Hematology/Oncology - Santa Monica ( Site 8905) | Los Angeles | California | 90404 | Recruiting |
| Norton Cancer Institute - Downtown ( Site 8900) | Louisville | Kentucky | 40202 | Completed |
| The Cancer and Hematology Centers ( Site 8912) | Grand Rapids | Michigan | 49503 | Recruiting |
| Hematology-Oncology Associates of Central NY, P.C. ( Site 8925) | East Syracuse | New York | 13057 | Recruiting |
| Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 8907) | New York | New York | 10032 | Completed |
| UPMC Hillman Cancer Center-UPMC ( Site 8904) | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| University of Texas MD Anderson Cancer Center ( Site 8920) | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 39 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06445972, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 23, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06445972 live on ClinicalTrials.gov.