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First-line Gemcitabine/Cisplatin +/- Avelumab in Locally Advanced or Metastatic Bladder Carcinoma

NCT03324282 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-05-22

No results posted yet for this study

Summary

This study will assess efficacy (based on response rate) and safety (based on grade ≥ 3 severe adverse effects) of the combination Gemcitabine Cisplatin (GC) + anti-PD-L1 (avelumab) in first-line treatment for locally advanced or metastatic urothelial bladder cancer patients, after 6 cycles of treatment (or at 18 weeks if less than 6 cycles have been given, or earlier if a second line treatment is needed, before this new anticancer treatment has been started).

Conditions

  • Bladder Carcinoma

Interventions

DRUG

Avelumab

Combination of Gemcitabin-Cisplatin and avelumab given for 6 cycles (each cycle is 21 days)

DRUG

GC

Combination of Gemcitabin-Cisplatin given for 6 cycles (each cycle is 21 days)

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Alain RAVAUD, MD. PhD · University Hospital, Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-23
Primary Completion
2021-12-31
Completion
2022-01-14

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03324282 on ClinicalTrials.gov