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The University of Southampton
Southampton Clinical Trials Unit

BL13

Title

A Randomised Phase II Trial Assessing Trimodality Therapy With or Without Adjuvant Durvalumab (MEDI4736) to Treat Patients with Muscle-Invasive Bladder Cancer

Description

A phase II study to compare disease-free survival in participants receiving durvalumab after initial treatment, to participants receiving surveillance alone after initial treatment for bladder cancer. The study investigates whether this new type of drug called durvalumab can be used in combination with the initial treatment participants receive for a type of bladder cancer which has grown into the muscle wall of their bladder. Recently, clinical trials have shown that a drug similar to durvalumab can help people with bladder cancer especially in combination with prior treatment.

Objectives

Primary Objective 

  • Determine if durvalumab when used in combination following standard trimodality therapy improves disease-free-survival when compared to surveillance alone in patients with T2 or more muscle-invasive bladder cancer.

Secondary Objectives

  • Compare non muscle-invasive bladder cancer recurrence rate (< T2).
  • Comparison of loco-regional control rate (LCR) between study arms at the 12 week visit.
  • Compare overall and bladder intact disease-free survival between study arms.
  • Compare patterns of disease recurrence between study arms.
  • Compare metastasis-free survival between arms.
  • Compare safety between study arms.
  • Compare quality of life between study arms.
  • Compare cost effectiveness and health economics between study arms.

Tertiary Objectives

  • Exploratory analysis of disease-free and overall survival in relevant molecular subgroups.
  • To perform a retrospective comparison of PD-L1 status (PD-L1 + versus PD-L1 -) and its prognostic and predictive impact on outcomes.

Trial Design

This is an international,  multi-centre, randomised phase II trial in patients with muscle-invasive bladder cancer. The study has two arms. Patients will be randomised to either durvalumab or surveillance. All patients randomised to the treatment arm will receive durvalumab 1,500 mg IV on Day 1 of a 4 weekly cycle for 12 months. All patients will be followed up post-treatment/surveillance every 3 months until recurrence and every 6 months after recurrence until death.

Trial Status

UK - In set up 

Population

Adult patients with a histologic diagnosis of transitional cell carcinoma of the bladder with completion of prior trimodality therapy (surgery, chemotherapy and radiation) at least 42 days prior to study enrolment. Stage T2-T4a N0M0.

N = 238 patients (global) 50 patients (UK)

Trial Team:

Senior Trial Manager:

Denise Dunkley (023 8120 3507) 

Trial Manager:

Sarah-Jane Bibby (023 8120 5334)

Trial Monitor:

Kim Mallard (023 8120 5598)

QRT:

Keira Fines (023 8120 4138) 

Contact information

Email:    BL13trial@soton.ac.uk

Fax:    0844 7740 621 

SAE Reporting:   ctu@soton.ac.uk   or 0844 7740 621

 

 

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