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RECRUITING Phase 1

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

NCT06445972 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 210 participants
Start Date 2024-08-07
Est. Completion 2030-08-08
Phase Phase 1

Sponsor

Merck Sharp & Dohme

741 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06445972 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Region M. de Santiago, New York, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06445972?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial