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ACTIVE NOT RECRUITING Phase 3

Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy

NCT04637594 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 3 participants
Start Date 2022-05-27
Est. Completion 2030-09
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04637594

The ClinicalTrials.gov registry entry for NCT04637594 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04637594 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Alaska, California, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04637594?

The interventions under investigation include: Pembrolizumab (DRUG), Atezolizumab (DRUG), Nivolumab (DRUG), Durvalumab (DRUG), Avelumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04637594?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial