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Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer

NCT02546661 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2025-12-29

No results posted yet for this study

Summary

This is an open label, multi-drug, biomarker-directed, multi-centre, multi-arm, Phase 1b study in patients with muscle invasive bladder cancer (MIBC) (urothelial) who have progressed on prior treatment. This study is modular in design, allowing evaluation of the safety, tolerability, pharmacokinetics and anti-tumour activity of multiple agents as monotherapy and as combinations of different novel anti-cancer agents.

The study will consist of a number of study modules (sub-studies), each evaluating the safety and tolerability of a specific agent or combination.

Conditions

Interventions

DRUG

AZD4547

AZD4547 Monotherapy vs. MEDI4736 (durvalumab) + AZD4547 1:1 Randomization.

DRUG

MEDI4736

MEDI4736

DRUG

Olaparib

MEDI4736 (durvalumab) + Olaparib

DRUG

AZD1775

MEDI4736 (durvalumab) + AZD1775

DRUG

Vistusertib

MEDI4736 (durvalumab) + Vistusertib

DRUG

AZD9150

MEDI4736 (durvalumab) + AZD9150

DRUG

Selumetinib

MEDI4736 (durvalumab) + Selumetinib

Sponsors & Collaborators

Principal Investigators

  • Thomas Powles, MBBS, MRCP, MD · Barts Cancer Center, Barts and The London School of Medicine and Denistry

  • Hendrik-Tobias Arkenau, MD, PhD · Sarah Cannon Research Institute, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-28
Primary Completion
2020-03-18
Completion
2026-01-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT02546661 on ClinicalTrials.gov