CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
Atezolizumab +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03513952
NCT03513952Phase 2Completed

A Randomized Phase II Study of Atezolizumab (MPDL3280A) Plus Recombinant Human IL7 (CYT107) in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

National Cancer Institute (NCI)·interventional·Posted May 2, 2018·Updated Jul 26, 2024

In Brief

A Phase 2 clinical trial evaluating Atezolizumab, Biopsy, and 6 other interventions for Advanced Bladder Urothelial Carcinoma and 23 related conditions. Completed, enrolled 47 participants across 9 sites.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 2, 2018
Enrollment StartJun 5, 2019
Primary CompletionSep 30, 2023
Study CompletionApr 1, 2024
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 8.2 years ago

Interventions

Atezolizumabdrug

Given IV

Biopsyprocedure

Undergo biopsy of tumor

Biospecimen Collectionprocedure

Undergo collection of blood and stool samples

Computed Tomographyprocedure

Undergo CT

Glycosylated Recombinant Human Interleukin-7biological

Given IM

Laboratory Biomarker Analysisother

Correlative studies

Magnetic Resonance Imagingprocedure

Undergo MRI

Positron Emission Tomography and Computed Tomography Scanprocedure

Undergo PET/CT