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NCT03513952 · ClinicalTrials.gov registry record · Phase 2

Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma

A Phase 2 study of Metastatic Urothelial Carcinoma and Metastatic Bladder Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
47
Enrollment target
9
Study locations

NCT03513952: Completed Phase 2 study of Metastatic Urothelial Carcinoma and Metastatic Bladder Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).

NCT03513952 is a Phase 2 study of Metastatic Urothelial Carcinoma and Metastatic Bladder Urothelial Carcinoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 47 participants, below the 129-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (64% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03513952, a Phase 2 study of Metastatic Urothelial Carcinoma and Metastatic Bladder Urothelial Carcinoma, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
47 participants
Enrollment target
9
Study locations

Study Summary

This phase II trial studies how well atezolizumab when given with glycosylated recombinant human interleukin-7 (CYT107) works in treating patients with urothelial carcinoma that has spread to nearby tissue or lymph nodes (locally advanced), cannot be removed by surgery (inoperable), or has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. CYT107 is a biological product naturally made by the body that may stimulate the immune system to destroy tumor cells. Giving atezolizumab and CYT107 may work better in treating patients with locally advanced, inoperable, or metastatic urothelial carcinoma compared to atezolizumab alone.

Primary Outcome

ORR is defined as the proportion of patients who have achieved Complete Response (CR) - disappearance of all target lesions or Partial Response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; Overall Response (OR) = CR + PR.

Conditions Studied

Metastatic Urothelial Carcinoma Metastatic Bladder Urothelial Carcinoma Metastatic Ureter Urothelial Carcinoma Metastatic Urethral Urothelial Carcinoma Metastatic Renal Pelvis Urothelial Carcinoma Advanced Bladder Urothelial Carcinoma Advanced Ureter Urothelial Carcinoma Recurrent Bladder Urothelial Carcinoma Recurrent Renal Pelvis Urothelial Carcinoma Recurrent Ureter Urothelial Carcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Atezolizumab
  • PROCEDURE Biopsy
  • BIOLOGICAL Glycosylated Recombinant Human Interleukin-7

Study Locations (9)

Hawaii

  • Straub Clinic and Hospital - Honolulu
  • University of Hawaii Cancer Center - Honolulu

California

  • Kaiser Permanente-Riverside - Riverside

Florida

  • Moffitt Cancer Center - Tampa

Illinois

  • University of Chicago Comprehensive Cancer Center - Chicago

Louisiana

  • East Jefferson General Hospital - Metairie

Missouri

  • Washington University School of Medicine - St Louis

New York

  • Roswell Park Cancer Institute - Buffalo

Washington

  • FHCC South Lake Union - Seattle

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2019-06-05
Est. Completion 2024-04-01
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT03513952 record still lists

NCT03513952 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 129-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (64% lower).

The record links to 10 conditions, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT03513952 lists 9 locations in 8 states (Hawaii, California, Florida).

Frequently Asked Questions

What is clinical trial NCT03513952 about?

NCT03513952 is a clinical study titled "Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma". This phase II trial studies how well atezolizumab when given with glycosylated recombinant human interleukin-7 (CYT107) works in treating patients with urothelial carcinoma that has spread to nearby tissue or lymph nodes (locally advanced), cannot be removed by surgery (inoperable), or has spread to...

What is the current status of trial NCT03513952?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2019-06-05. Estimated completion is 2024-04-01.

What conditions does trial NCT03513952 study?

This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Metastatic Bladder Urothelial Carcinoma, Metastatic Ureter Urothelial Carcinoma, Metastatic Urethral Urothelial Carcinoma, Metastatic Renal Pelvis Urothelial Carcinoma.

What interventions are being tested in trial NCT03513952?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Atezolizumab (DRUG), Biopsy (PROCEDURE), Glycosylated Recombinant Human Interleukin-7 (BIOLOGICAL).

Who is sponsoring clinical trial NCT03513952?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03513952 being conducted?

This trial has 9 study locations across California, Florida, Hawaii, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Urothelial Carcinoma

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 NCT03513952's enrollment target sits among peer trials

47 16th of 30 higher than 15 of 30 other Metastatic Urothelial Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Urothelial Carcinoma 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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Related registry views

Source: ClinicalTrials.gov NCT03513952, the US trial registry maintained by the National Library of Medicine. NCT03513952 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.