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NCT04897022 · ClinicalTrials.gov registry record · Phase 1
A Study of Pembrolizumab and Radiation Therapy in People With Mesothelioma
A Phase 1 study of Malignant Pleural Mesothelioma, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
- 7
- Study locations
NCT04897022: Active Phase 1 study of Malignant Pleural Mesothelioma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04897022 is a Phase 1 study of Malignant Pleural Mesothelioma that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 7 participants, below the 89-participant average among 6 other Malignant Pleural Mesothelioma trials with a reported enrollment target (92% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04897022, a Phase 1 study of Malignant Pleural Mesothelioma, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to find out whether IMPRINT in combination with pembrolizumab is a safe treatment for people with malignant pleural mesothelioma (MPM).The highest dose of IMPRINT that causes few or mild side effects when given in combination with pembrolizumab will be found. Once the highest safe dose of IMPRINT is found, it will be tested in combination with pembrolizumab in future participants to see whether the combination may be an effective treatment for MPM.
Primary Outcome
The first primary objective of this study is to determine the MTD of IMPRINT among the three candidate doses: 400cGy x5 fractions, 500cGy x5 fractions and 600cGy x5 fractions. These dose levels will be evaluated using a modified Continuous Reassessment Method (CRM) starting with the lowest dose level 400cGy x5 fractions. Determined by the first 12 participants enrolled to the study.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- RADIATION IMPRINT
Study Locations (7)
New York
- Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau (Limited protocol activities) - Rockville Centre
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited protocol activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-08-10 |
| Est. Completion | 2026-08 |
| Phase | Phase 1 |
What the registry record for NCT04897022 still lists
NCT04897022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 89-participant average among 6 other Malignant Pleural Mesothelioma trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Malignant Pleural Mesothelioma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04897022 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT04897022 about?
NCT04897022 is a clinical study titled "A Study of Pembrolizumab and Radiation Therapy in People With Mesothelioma". The purpose of this study is to find out whether IMPRINT in combination with pembrolizumab is a safe treatment for people with malignant pleural mesothelioma (MPM).The highest dose of IMPRINT that causes few or mild side effects when given in combination with pembrolizumab will be found. Once the hi...
What is the current status of trial NCT04897022?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2021-08-10. Estimated completion is 2026-08.
What conditions does trial NCT04897022 study?
This clinical trial studies the following conditions: Malignant Pleural Mesothelioma.
What interventions are being tested in trial NCT04897022?
The interventions under investigation include: Pembrolizumab (DRUG), IMPRINT (RADIATION).
Who is sponsoring clinical trial NCT04897022?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04897022 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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