Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06445972 · ClinicalTrials.gov registry record · Phase 1
Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)
A Phase 1 study of Esophageal Cancer and Esophageal Neoplasms, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 210
- Enrollment target
- 20
- Study locations
NCT06445972 is a Phase 1 study of Esophageal Cancer and Esophageal Neoplasms that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 210 participants, below the 497-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 16 states.
The verdict
NCT06445972, a Phase 1 study of Esophageal Cancer and Esophageal Neoplasms, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 210 participants
- Enrollment target
- 20
- Study locations
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 Studied
Interventions
- DRUG Paclitaxel
- BIOLOGICAL Ramucirumab
- BIOLOGICAL Sacituzumab Tirumotecan
- DRUG Rescue Medications
- BIOLOGICAL HER3-DXd
Study Locations (20)
Region M. de Santiago
- FALP-UIDO ( Site 8400) - Santiago
- Centro de Oncología de Precisión-Oncology ( Site 8404) - Santiago
- Clínica UC San Carlos de Apoquindo ( Site 8405) - Santiago
- Bradfordhill-Clinical Area ( Site 8401) - Santiago
New York
- Hematology-Oncology Associates of Central NY, P.C. ( Site 8925) - East Syracuse
- Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 8907) - New York
Arizona
- University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 8927) - Tucson
California
- UCLA Hematology/Oncology - Santa Monica ( Site 8905) - Los Angeles
Kentucky
- Norton Cancer Institute - Downtown ( Site 8900) - Louisville
Michigan
- The Cancer and Hematology Centers ( Site 8912) - Grand Rapids
Pennsylvania
- UPMC Hillman Cancer Center-UPMC ( Site 8904) - Pittsburgh
Texas
- University of Texas MD Anderson Cancer Center ( Site 8920) - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2024-08-07 |
| Est. Completion | 2030-08-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06445972
The ClinicalTrials.gov registry entry for NCT06445972 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 497-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (58% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Esophageal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Paclitaxel is the first listed.
NCT06445972 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Region M. de Santiago, New York, Arizona.
Frequently Asked Questions
What is clinical trial NCT06445972 about?
NCT06445972 is a clinical study titled "Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)". 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 w...
What is the current status of trial NCT06445972?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 210 participants. The study started on 2024-08-07. Estimated completion is 2030-08-08.
What conditions does trial NCT06445972 study?
This clinical trial studies the following conditions: Esophageal Cancer, Esophageal Neoplasms, Gastroesophageal Adenocarcinoma, Gastroesophageal Junction.
What interventions are being tested in trial NCT06445972?
The interventions under investigation include: Paclitaxel (DRUG), Ramucirumab (BIOLOGICAL), Sacituzumab Tirumotecan (BIOLOGICAL), Rescue Medications (DRUG), HER3-DXd (BIOLOGICAL).
Who is sponsoring clinical trial NCT06445972?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06445972 being conducted?
This trial has 20 study locations across Arizona, California, Kentucky, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Esophageal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
RECRUITING · Phase 1
-
Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
RECRUITING · Phase 1
-
64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer
RECRUITING · Phase 1
-
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TJ101 in Patients With Advanced/Metastatic Solid Tumors
RECRUITING · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.