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NCT05583708 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer
A Phase 2 study of Merkel Cell Carcinoma, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 3
- Study locations
NCT05583708: Recruiting Phase 2 study of Merkel Cell Carcinoma, sponsored by Weill Medical College of Cornell University.
NCT05583708 is a Phase 2 study of Merkel Cell Carcinoma that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 18 participants, below the 50-participant average among 26 other Merkel Cell Carcinoma trials with a reported enrollment target (64% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05583708, a Phase 2 study of Merkel Cell Carcinoma, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to find out what effects an immunotherapy drug, called pembrolizumab, combined with a radioactive drug, called lutetium Lu 177 dotatate (Lutathera®) have on patients with Merkel cell carcinoma. Pembrolizumab works by helping patient's immune system to fight cancer. Lutathera works by killing cancer cells. Pembrolizumab is approved by the FDA to treat Merkel cell cancer and has caused some Merkel cell cancers to shrink and/or resolve. Lutathera is FDA-approved to treat some neuroendocrine tumors and has caused some patient's neuroendocrine tumors to shrink and allowed them to live longer, but it is not approved by the FDA to treat Merkel cell cancer. The combination of Lutathera and pembrolizumab to treat Merkel cell cancer is investigational, which means this combination is not approved by the FDA to treat Merkel cell cancer.
Primary Outcome
The objective response rate is the proportion of all subjects with confirmed Partial Response (PR) or Complete Response (CR) according to RECIST 1.1.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Lutetium Lu 177 dotatate
Study Locations (3)
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
New York
- Weill Cornell Medicine/NewYork-Presbyterian Hospital - New York
Wisconsin
- University of Wisconsin Carbone Cancer Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2023-08-03 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
What NCT05583708 shows while recruiting
NCT05583708 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 50-participant average among 26 other Merkel Cell Carcinoma trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Merkel Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05583708 reports a single indexed study location in Iowa, New York, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT05583708 about?
NCT05583708 is a clinical study titled "Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer". The purpose of this study is to find out what effects an immunotherapy drug, called pembrolizumab, combined with a radioactive drug, called lutetium Lu 177 dotatate (Lutathera®) have on patients with Merkel cell carcinoma. Pembrolizumab works by helping patient's immune system to fight cancer. Lutat...
What is the current status of trial NCT05583708?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2023-08-03. Estimated completion is 2026-09.
What conditions does trial NCT05583708 study?
This clinical trial studies the following conditions: Merkel Cell Carcinoma.
What interventions are being tested in trial NCT05583708?
The interventions under investigation include: Pembrolizumab (DRUG), Lutetium Lu 177 dotatate (DRUG).
Who is sponsoring clinical trial NCT05583708?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05583708 being conducted?
This trial has 3 study locations across Iowa, New York, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05583708's enrollment target sits among peer trials
18 20th of 26 higher than 6 of 26 other Merkel Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Merkel Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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