Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06571708 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)
A Phase 2 study of Bladder Cancer and Muscle-Invasive Bladder Carcinoma, sponsored by Columbia University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT06571708: Recruiting Phase 2 study of Bladder Cancer and Muscle-Invasive Bladder Carcinoma, sponsored by Columbia University.
NCT06571708 is a Phase 2 study of Bladder Cancer and Muscle-Invasive Bladder Carcinoma that is actively recruiting participants, run by Columbia University. The registered enrollment target is 36 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06571708, a Phase 2 study of Bladder Cancer and Muscle-Invasive Bladder Carcinoma, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to learn if gemcitabine/cisplatin plus cemiplimab with or without fianlimab works to treat bladder cancer in adults. The main question it aims to answer is: Can gemcitabine, cisplatin, and cemiplimab with or without fianlimab treat bladder cancer? Participants will be randomly selected (like the loss of a coin) to treatment with gemcitabine, cisplatin, cemiplimab, and fianlimab or gemcitabine, cisplatin, and cemiplimab. Participants will: * Undergo transurethral resection of bladder tumor (TURBT) followed by the start of treatment, receive 4 cycles of treatment (21 day cycles) * After 4 cycles of treatment, patients will undergo repeat maximal TURBT with imaging * Participants with a complete response will continue maintenance cemiplimab or cemiplimab/fianlimab for 13 more cycles with imaging every 3 months * Participants without a complete clinical response will undergo cystectomy (bladder surgery).
Primary Outcome
Rate of clinical complete response after 4 cycles of neoadjuvant chemoimmunotherapy. Complete clinical response will be defined as: * No high-grade malignancy on repeat TURBT * No malignant cells on urine cytology * No definitive evidence of invasive local or metastatic disease on cross-sectional imaging (CT chest, abdomen, and pelvis with contrast or, if renal dysfunction, MRI with contrast) Cytoscopy and imaging should occur within 4 weeks of end of neoadjuvant therapy.
Conditions Studied
Interventions
- DRUG Cemiplimab
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG Fianlimab
Study Locations (1)
New York
- Columbia University Irving Medical Center/ New York Presbyterian Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-08-14 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
What NCT06571708 shows while recruiting
NCT06571708 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 4 interventions - of which Cemiplimab is the first listed.
NCT06571708 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06571708 about?
NCT06571708 is a clinical study titled "Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)". The goal of this clinical trial is to learn if gemcitabine/cisplatin plus cemiplimab with or without fianlimab works to treat bladder cancer in adults. The main question it aims to answer is: Can gemcitabine, cisplatin, and cemiplimab with or without fianlimab treat bladder cancer? Participants wil...
What is the current status of trial NCT06571708?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2025-08-14. Estimated completion is 2028-12.
What conditions does trial NCT06571708 study?
This clinical trial studies the following conditions: Bladder Cancer, Muscle-Invasive Bladder Carcinoma.
What interventions are being tested in trial NCT06571708?
The interventions under investigation include: Cemiplimab (DRUG), Cisplatin (DRUG), Gemcitabine (DRUG), Fianlimab (DRUG).
Who is sponsoring clinical trial NCT06571708?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06571708 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bladder Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06571708's enrollment target sits among peer trials
36 129th of 175 higher than 47 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer 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
-
Telehealth Intervention for Ostomy Self-Management
RECRUITING · Phase 2
-
Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery
RECRUITING · Phase 2
-
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
RECRUITING · Phase 2
-
Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer
RECRUITING · Phase 2
-
Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer
RECRUITING · Phase 2
-
Intravenous Ascorbate Plus Gemcitabine/Carboplatin: A Novel and Cost-Effective Alternative With Evident Efficacy in Patients With Muscle Invasive Bladder Cancer
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00929006 · 36 participants · Early Phase 1
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
- NCT01891318 · 36 participants · Phase 1
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
- NCT02291848 · 36 participants · Phase 1
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
- NCT02366819 · 36 participants · Phase 4
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI