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Avelumab Plus Carboplatin-gemcitabine in Urothelial Carcinoma

NCT03390595 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2023-10-18

No results posted yet for this study

Summary

Phase II Multicentre, randomized, open-label study to evaluate the safety and efficacy of avelumab with gemcitabine/carboplatin versus gemcitabine/carboplatin alone in patients with unresectable or metastatic urothelial carcinoma (UC) who have not received prior systemic therapy and who are ineligible to receive cisplatin-based therapy.

Conditions

  • Metastatic Urothelial Cancer

Interventions

COMBINATION_PRODUCT

avelumab 10mg/kg with carboplatin/gemcitabine

Dosage and schedule: * Avelumab 10mg/kg will be administered over 60 minutes in the experimental arm as follows: * Intravenously every 2 weeks for two cycles. * During carboplatin-gemcitabine treatment, on day +15 (carboplatin will be administered on day 1; gemcitabine on days 1 and 8), for six cycles. Intravenously every 2 weeks until progressive disease o intolerance. * Intravenously every 2 weeks until progressive disease or intolerance. * Carboplatin-gemcitabine will be administered for six cycles, every three weeks, with the following posology, according to the SmPC * Carboplatin 5AUC day +1. * Gemcitabine 1000mg/m2 day +1 and +8.

COMBINATION_PRODUCT

carboplatin/gemcitabine alone

•Carboplatin-gemcitabine will be administered for six cycles, every three weeks, with the following posology, according to the SmPC * Carboplatin 5AUC day +1. * Gemcitabine 1000mg/m2 day +1 and +8.

Sponsors & Collaborators

  • Merck, S.L., Spain

    collaborator INDUSTRY

  • Pivotal S.L.

    collaborator INDUSTRY

  • Associació per a la Recerca Oncologica, Spain

    lead OTHER

Principal Investigators

  • Joaquín Bellmunt, MD, PhD · Hospital del Mar

  • Alejo Rodríguez-Vida, MD, PhD · Hospital del Mar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-17
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Spain

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 NCT03390595 on ClinicalTrials.gov