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NCT05647265 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma
A Phase 2 study of Pleural Biphasic Mesothelioma and Pleural Sarcomatoid Mesothelioma, sponsored by Alliance for Clinical Trials in Oncology.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 20
- Study locations
NCT05647265: Recruiting Phase 2 study of Pleural Biphasic Mesothelioma and Pleural Sarcomatoid Mesothelioma, sponsored by Alliance for Clinical Trials in Oncology.
NCT05647265 is a Phase 2 study of Pleural Biphasic Mesothelioma and Pleural Sarcomatoid Mesothelioma that is actively recruiting participants, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05647265, a Phase 2 study of Pleural Biphasic Mesothelioma and Pleural Sarcomatoid Mesothelioma, is actively recruiting participants, sponsored by Alliance for Clinical Trials in Oncology.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving immunotherapy before surgery may be more effective at controlling disease in patients with sarcomatoid mesothelioma than giving immunotherapy alone.
Primary Outcome
The rate of surgery after neoadjuvant immunotherapy among the feasibility analysis population as well as the 80% and 95% exact Clopper-Pearson confidence intervals will be estimated.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL Nivolumab
- PROCEDURE Surgical Procedure
- BIOLOGICAL Ipilimumab
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
California
- PCR Oncology - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- UC San Diego Moores Cancer Center - La Jolla
- Providence Queen of The Valley - Napa
- Providence Medical Foundation - Santa Rosa - Santa Rosa
- Providence Santa Rosa Memorial Hospital - Santa Rosa
Delaware
- Beebe Medical Center - Lewes
- Beebe South Coastal Health Campus - Millville
- Delaware Clinical and Laboratory Physicians PA - Newark
- Helen F Graham Cancer Center - Newark
Arizona
- Kingman Regional Medical Center - Kingman
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2024-11-27 |
| Est. Completion | 2026-12-15 |
| Phase | Phase 2 |
What NCT05647265 shows while recruiting
NCT05647265 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Pleural Biphasic Mesothelioma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT05647265 names 20 study sites across 4 states, led by Alaska, California, Delaware.
Frequently Asked Questions
What is clinical trial NCT05647265 about?
NCT05647265 is a clinical study titled "Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma". This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's...
What is the current status of trial NCT05647265?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2024-11-27. Estimated completion is 2026-12-15.
What conditions does trial NCT05647265 study?
This clinical trial studies the following conditions: Pleural Biphasic Mesothelioma, Pleural Sarcomatoid Mesothelioma.
What interventions are being tested in trial NCT05647265?
The interventions under investigation include: Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Nivolumab (BIOLOGICAL), Surgical Procedure (PROCEDURE), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05647265?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05647265 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05647265's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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