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NCT03732677Phase 3ACTIVE NOT RECRUITING

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

Study Summary

A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

Conditions
Muscle Invasive Bladder Cancer
Interventions / Drugs
DurvalumabCisplatinGemcitabine
View on ClinicalTrials.gov ↗
Sponsor
AZN
AstraZeneca
Oncology/Respiratory
F16/100
Study Details
Enrollment1063 participants
Primary Completion—
Lead SponsorAstraZeneca
Data Retrieved2026-04-11 02:55:19.910297+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 1,063 participants
Sponsor Catalyst Profile

AstraZeneca (AZN) is the sponsoring company for this trial. BiotechSign currently grades this company F (16/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

AZN Full Pipeline →All Companies →
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