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NCT04637594 · ClinicalTrials.gov registry record · Phase 3
Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy
A Phase 3 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 3
- Enrollment target
- 20
- Study locations
NCT04637594: Active Phase 3 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, sponsored by Alliance for Clinical Trials in Oncology.
NCT04637594 is a Phase 3 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 3 participants, below the 131-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04637594, a Phase 3 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 3 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares survival in urothelial cancer patients who stop immune checkpoint inhibitor treatment after being treated for about a year to those patients who continue treatment with immune checkpoint inhibitors. Immunotherapy with monoclonal antibodies, such as avelumab, durvalumab, pembrolizumab, atezolizumab, and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stopping immune checkpoint inhibitors early may still make the tumor shrink and patients may have similar survival rates as the patients who continue treatment. Stopping treatment early may also lead to fewer treatment-related side effects, an improvement in mental health, and a lower cost burden to patients.
Primary Outcome
OS is the length of time patients are alive after registering to receive protocol treatment. Patients who are lost to follow-up or are not known to be deceased at the time of study analysis will be censored at the time of last patient contact. Cox models will be used to compare the outcome between the two treatment groups.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Atezolizumab
- DRUG Nivolumab
- DRUG Durvalumab
- DRUG Avelumab
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
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Kaiser Permanente Dublin - Dublin
- Kaiser Permanente-Fremont - Fremont
- Fresno Cancer Center - Fresno
- Kaiser Permanente-Fresno - Fresno
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- University of Arkansas for Medical Sciences - Little Rock
Arizona
- Cancer Center at Saint Joseph's - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-05-27 |
| Est. Completion | 2030-09 |
| Phase | Phase 3 |
What the registry record for NCT04637594 still lists
NCT04637594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 131-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (98% lower).
The record links to 10 conditions, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04637594 names 20 study sites across 4 states, led by Alaska, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04637594 about?
NCT04637594 is a clinical study titled "Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy". This phase III trial compares survival in urothelial cancer patients who stop immune checkpoint inhibitor treatment after being treated for about a year to those patients who continue treatment with immune checkpoint inhibitors. Immunotherapy with monoclonal antibodies, such as avelumab, durvalumab,...
What is the current status of trial NCT04637594?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 3 participants. The study started on 2022-05-27. Estimated completion is 2030-09.
What conditions does trial NCT04637594 study?
This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Metastatic Bladder Urothelial Carcinoma, Locally Advanced Bladder Urothelial Carcinoma, Metastatic Ureter Urothelial Carcinoma.
What interventions are being tested in trial NCT04637594?
The interventions under investigation include: Pembrolizumab (DRUG), Atezolizumab (DRUG), Nivolumab (DRUG), Durvalumab (DRUG), Avelumab (DRUG).
Who is sponsoring clinical trial NCT04637594?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04637594 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04637594's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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