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Safety & Efficacy of Durvalumab+Neoadjuvant Chemotherapy for High-risk Urothelial Carcinoma of the Upper Urinary Tract

NCT04617756 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-05-30

No results posted yet for this study

Summary

Following radical nephrectomy (RNU) for upper tract urothelial carcinoma (UTUC) most patients face a poor prognosis. Indeed, patients who have undergone RNU for UTUC have 5-year recurrence-free and cancer specific survival probabilities of 69% and 73% respectively.

The primary objective of this study is to assess the pathological complete response rate to combination therapy with neoadjuvant durvalumab and chemotherapy (Gemcitabine/Cisplatin) before surgery in patients with high-risk, localized, non-metastatic urothelial carcinomas of the upper tract.

Conditions

Interventions

DRUG

Patients receiving neoadjuvant therapy before radical nephrectomy

Chemotherapy using either a combination of Gemcitabine/Cisplatin and neoadjuvant immunotherapy therapy with Durvalumab (MEDI 4736) or Chemotherapy with either Gemcitibine/Carboplatin and neoadjuvant immunotherapy therapy with Durvalumab (MEDI 4736)

Sponsors & Collaborators

  • Pitié-Salpêtrière Hospital

    collaborator OTHER

  • Hôpital Bichat-Claude Bernard, 75018 Paris

    collaborator UNKNOWN

  • Hopital Foch 92151 Suresnes

    collaborator UNKNOWN

  • Institut Paoli-Calmettes

    collaborator OTHER

  • European Georges Pompidou Hospital

    collaborator OTHER

  • Saint-Louis Hospital, Paris, France

    collaborator OTHER

  • Centre Hospitalier Lyon Sud

    collaborator OTHER

  • Center Eugene Marquis

    collaborator OTHER

  • IUCT ONCOPOLE

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-29
Primary Completion
2025-01-01
Completion
2026-10-01

Countries

  • France

Study Locations

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Entities

Diseases

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 NCT04617756 on ClinicalTrials.gov