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Durvalumab (MEDI4736) and TREmelimumab in NEOadjuvant Bladder Cancer Patients (DUTRENEO)

NCT03472274 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-04-13

No results posted yet for this study

Summary

In the treatment of localized/locally advanced urothelial cancer, there are several questions that have not yet been resolved, such as the limited benefit of cisplatin-based chemotherapy in the adjuvant or neoadjuvant context, the difficulty in establishing which groups actually benefit from either perioperative treatment and what are the molecular markers that could help us predict the response to this treatment to allow a better selection of patients. On the other hand, not all patients are candidates for cisplatin-based chemotherapy and carboplatin is not comparable in activity, so there is an urgent need to find other drugs that may offer a therapeutic opportunity to these patients.

In the context of metastatic disease, immunotherapy has been able to modify the natural history of this disease, administered as monotherapy, but the combination with double immune checkpoint inhibitors is also being evaluated with promising results. Even this therapeutic strategy is being advanced to the context of adjuvant and neoadjuvant treatment of urothelial tumors. In this sense, on the one hand, the present study, as a research in the neoadjuvant setting, constitutes the opportunity to define molecular phenotypes in bladder cancer since the design of this study will allow both, to evaluate the efficacy of the drug when the tumor is operable and to carry out an extensive analysis of biomarkers in the tumor tissue of these patients with an in-vivo evaluation of immune-based therapy activity. On the other hand, it allows to evaluate a strategy of double-immune checkpoint inhibitors that has already demonstrated activity in metastatic disease and, taking into account, the modest benefit of standard chemotherapy in the perioperative context: platinum-based neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer (MIBC) Modest increase in overall survival, but only a subset of eligible patients are eligible to receive it. In addition, radical cystectomy alone, in MIBC patients, presents a 5-year relapse rate of 10-50%.

Conditions

Interventions

DRUG

Durvalumab

Durvalumab 1500 mg every 4 weeks x 3 cycles

DRUG

Tremelimumab

Tremelimumab 75 mg every 4 weeks x 3 cycles

DRUG

Cisplatin-based neoadjuvant chemotherapy

Regimen 1: 21-day treatment cycle x 3 cycles. * Gemcitabine 1,000-1,200 mg/m2 intravenously on days 1 and 8 every 21 days. * Cisplatin 70 mg/m2 intravenously on day 1 every 21 days. Regimen 2: ddMVAC 14-day treatment cycle x 4 doses. * Methotrexate 30mg/m2 intravenously on day 1 * Vinblastine 3mg/m2 intravenously on day 2 * Doxorubicin 30mg/m2 intravenously on day 2 * Cisplatin 70mg/m2 intravenously on day 2 Granulocyte colony-stimulating factor (G-CSF) for 7 consecutive days (days 4 through 10). Regimen 3: 21-day treatment cycle x 3 cycle * Gemcitabine 1,000 mg/m2 intravenously on day 1 and 8 * Paclitaxel 80 mg/m2 intravenously on day 1 and 8 * Cisplatin 70mg/m2 intravenously on day 1

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • Fundacion CRIS de Investigación para Vencer el Cáncer

    lead OTHER

Principal Investigators

  • Enrique Grande, MD · MD Anderson Cancer Center Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-25
Primary Completion
2021-04-30
Completion
2023-04-12

Countries

  • Spain

Study Locations

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Drugs
Diseases
Companies

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 NCT03472274 on ClinicalTrials.gov