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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 - Closed to recruitment

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=190 patients (global) 40 patients (UK)

CRUK logo

This trial is endorsed by Cancer Research UK (award reference no. C1522/A27866)

Find out more about the BL-13 trial on the Cancer Research UK website .

Trial Team:

Senior Trial Manager:

Sarah-Jane Bibby

Trial Coordinator:

Sam Goode

Trial Monitor:

TBC

Patient and Public Involvement:

Global sponsor, CCTG, Patient Representatives Committee

Contact information

Email: [email protected]

SAE Reporting:

Email: [email protected]

Essential Trial Documents

BL13 - Protocol Admin Update #2, 22-Feb-2022

BL13 - UK Specific Protocol Appendix v5, 04-Apr-2022

BL13 - Appendix II Dose Mod-Toxicity MgmtGuidelines, 28-Oct-2021

BL13 - Memo_Clarification of 12 Week Biopsy Requirment 15-Nov-2021

BL 13 - Memo Remote Visits for Surveillance Arm Participants During Pandemic

BL13 - UK Informed Consent Form v4 04-Mar-2021

BL13 - GP Letter v1 03-Oct-2019

BL13 - Patient Screening Log v3 08-Apr-2020

BL13 - UK Master Patient Information Sheet v8, 09-Jun-2022

BL13 - Master Patient List_V1.0_06Mar2020

BL13 - Patient Treatment Card v2 17.12.19

BL13 - Pregnancy Information and Consent_V1_24Oct19

BL13 - UK Laboratory Manual v1 04.02.20

BL13 - QoL FACT-BL questionnaire

BL13 - Site Training Log Template v1 06-Jun-2019

BL13 - Site Delegation Log v1 12-Nov-2019

BL13 - CCTG RIPPLE International User Guide v1 04-Jun-2019

Pharmacy

BL13 - UK Pharmacy Manual v2 04-May-2020

BL13 UK Pharmacy_Appendix 1_Credo Return Instructions

BL13 UK Pharmacy_Appendix 1_TempTale4 USB Site Instruction Template

BL13 UK Pharmacy_Appendix 2_Drug Request Form v2_21-Feb-2022

BL13 UK Pharmacy_Appendix 3_Sample Packing List

BL13 UK Pharmacy_Appendix 4_Temp Excursion Notification Form_04May2020

BL13_AccountabilityLog_Durvalumab

BL13 - Durvalumab IB edition 17, 18-Oct-2022

Safety Reporting:

BL13 - CCTG EDC Data Management Guidebook for SAE

BL13 - CCTG Introduction to SAE Reporting in EDC

Data Entry & e CRFs:

BL13 - CCTG EDC Data Management Guidebook iMedidata

BL13 - CCTG Supporting Docs Upload Instructions Nov-2020

BL-13 - EDC RAVE Handy Tips v2 30-Jun-2021

BL13 - Timing of Reporting Period Example v2 30-Jun-2021

What are Mock CRFs?

Mock CRFs are meant to approximate the actual trial screens in the EDC system, i.e. provide users of the EDC system with a snap-shot of what each e-CRF looks like within the system, the data it collects etc. Several links are provided, each depicting a single Folder within the EDC system. Mock Forms within Folders are shown as boxes. Text highlighted in colour provides information that may or may not be directly visible on the screens, but which helps the user understand the flow of data collection.

Please note that these Mock Forms are only meant as a HELP TOOL for users who wish to know / prepare for the information content of the e-CRFs prior to actually logging into the EDC system. They are NOT meant to be used as worksheets.

Please do NOT complete or submit data on Mock Forms - all patient data must be provided on the EDC screens.

1. BL13 - Eligibility Checklist eCRF 12-Jan-2022

2. BL13 - F1 Baseline Report eCRF 01-May-2019

3. BL13 - ConMeds eCRF 12-Oct-2018

4. BL13 - Correlative Studies eCRF 15-Feb-2019

5. BL13 - SAE eCRF 13-May-2019

6. BL13 - F3 Treatment Report eCRF 15-May-2019

7. BL13 - End of Treatment Report OPT eCRF 15-May-2019

8. BL13 - F5P Post Treatment Report eCRF 01-Mar-2019

9. BL13 - F5 Follow-Up Report eCRF 10-Apr-2019

10. BL13 - F5S Short Follow-Up Report eCRF 26-Apr-2019

11. BL13 - F9 Relapse eCRF 13-Jun-2019

12. BL13 - F6 Death Report eCRF 13-Jun-2019

13. BL13 - Lost To Follow-Up eCRF 13-May-2019

14. BL13 - Withdrawal Of Consent eCRF 13-May-2019

Press releases, video clips and other external websites:

(University of Southampton cannot accept responsibility for external websites)

First UK Patients Recruited

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