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NCT05241340 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Sasanlimab With Radiation as an in Situ Vaccine for Cisplatin-ineligible Muscle Invasive Bladder Cancer
A Phase 2 study of Urothelial Carcinoma Bladder, sponsored by The Methodist Hospital Research Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT05241340: Active Phase 2 study of Urothelial Carcinoma Bladder, sponsored by The Methodist Hospital Research Institute.
NCT05241340 is a Phase 2 study of Urothelial Carcinoma Bladder that is active but no longer recruiting, run by The Methodist Hospital Research Institute. The registered enrollment target is 33 participants, below the 94-participant average among 16 other Urothelial Carcinoma Bladder trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05241340, a Phase 2 study of Urothelial Carcinoma Bladder, is active but no longer recruiting, sponsored by The Methodist Hospital Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective, single-institution, single-arm, phase II clinical trial that tests a novel strategy of neoadjuvant Sasanlimab, an immune checkpoint inhibitor (ICI), in combination with stereotactic body radiation therapy as an in-situ vaccination in patients, who are ineligible to receive cisplatin-based chemotherapy and undergoing radical cystectomy for muscle-invasive bladder cancer.
Primary Outcome
Combination of Sasanlimab and SBRT will be deemed both feasible and safe (composite outcome) if, after the treatment of 10 patients, ≥ 7 of 10 patients meet all of the following feasibility criteria: 1. Receive at least 1 dose of 2 of Sasanlimab 2. Receive at least 2 of 3 fractions SBRT 3. Undergo radical cystectomy RC within 4 weeks of completing therapy (after end of cycle 2) and meet all of the safety criteria, defined as not experiencing any following Common Terminology Criteria for Advers
Conditions Studied
Interventions
- RADIATION Stereotactic Body Radiation Therapy
- DRUG Sasanlimab
- PROCEDURE Radical Cystectomy + pelvic lymph node dissection + urinary diversion
Study Locations (1)
Texas
- Houston Methodist Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2022-02-15 |
| Est. Completion | 2027-04-01 |
| Phase | Phase 2 |
What the registry record for NCT05241340 still lists
NCT05241340 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 94-participant average among 16 other Urothelial Carcinoma Bladder trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Urothelial Carcinoma Bladder appearing as the primary indexed condition, and to 3 interventions - of which Stereotactic Body Radiation Therapy is the first listed.
NCT05241340 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05241340 about?
NCT05241340 is a clinical study titled "Neoadjuvant Sasanlimab With Radiation as an in Situ Vaccine for Cisplatin-ineligible Muscle Invasive Bladder Cancer". This is a prospective, single-institution, single-arm, phase II clinical trial that tests a novel strategy of neoadjuvant Sasanlimab, an immune checkpoint inhibitor (ICI), in combination with stereotactic body radiation therapy as an in-situ vaccination in patients, who are ineligible to receive cis...
What is the current status of trial NCT05241340?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2022-02-15. Estimated completion is 2027-04-01.
What conditions does trial NCT05241340 study?
This clinical trial studies the following conditions: Urothelial Carcinoma Bladder.
What interventions are being tested in trial NCT05241340?
The interventions under investigation include: Stereotactic Body Radiation Therapy (RADIATION), Sasanlimab (DRUG), Radical Cystectomy + pelvic lymph node dissection + urinary diversion (PROCEDURE).
Who is sponsoring clinical trial NCT05241340?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05241340 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05241340's enrollment target sits among peer trials
33 11th of 16 higher than 6 of 16 other Urothelial Carcinoma Bladder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Carcinoma Bladder 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.
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