82 Participants Needed

Durvalumab for Bladder Cancer

Recruiting at 30 trial locations
WP
Overseen ByWendy Parulekar
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out what effects durvalumab has on bladder cancer, combined with treatment after completion of surgery, chemotherapy and radiotherapy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use immunosuppressive medications within 28 days of starting the study, except for certain corticosteroids at low doses. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Durvalumab for bladder cancer?

Durvalumab has shown meaningful clinical activity in patients with metastatic urothelial carcinoma, a type of bladder cancer, in clinical studies. It has been approved by the FDA for patients whose cancer has progressed after chemotherapy, indicating its effectiveness in treating this condition.12345

Is durvalumab safe for human use?

Durvalumab has been studied for safety in various cancers, including bladder cancer. Common side effects include reduced appetite and diarrhea, with serious side effects occurring in about 24% of patients when used alone. Safety data from multiple studies suggest it is generally safe, but side effects can vary.12367

How is the drug durvalumab unique for treating bladder cancer?

Durvalumab is unique because it is a monoclonal antibody that blocks PD-L1, enhancing the body's immune response against cancer cells. It is specifically approved for patients with advanced bladder cancer who have not responded to platinum-based chemotherapy, offering a new option for those with limited treatment choices.12389

Research Team

WK

Wassim Kassouf

Principal Investigator

The Research Institute of the McGill University, Montreal QC Canada

Eligibility Criteria

Adults over 18 with muscle-invasive bladder cancer, who've completed surgery, chemo, and radiotherapy can join this trial. They should have no metastatic disease, a life expectancy over 6 months, good organ function, and be within certain weight and health status limits. Women/men of childbearing potential must agree to use effective contraception for 3 months post-treatment.

Inclusion Criteria

Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits placed on patients being considered for this trial.
Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
My bladder cancer was between stages T2 to T4a without spread to lymph nodes or distant organs at diagnosis.
See 17 more

Exclusion Criteria

I have not received a live vaccine in the last 30 days.
I have been treated with specific immune system targeting drugs before.
I haven't had serious autoimmune or inflammatory disorders in the last 3 years.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants undergo surgery, chemotherapy, and radiotherapy for muscle-invasive bladder cancer

12 weeks

Adjuvant Treatment

Participants receive durvalumab to assess its effects on bladder cancer post initial treatment

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

  • Durvalumab
Trial OverviewThe study is testing the effects of Durvalumab on bladder cancer when given after trimodality therapy (TMT), which includes surgery, chemotherapy, and radiation therapy. The goal is to see if adding Durvalumab improves outcomes compared to just TMT alone.
Participant Groups
2Treatment groups
Active Control
Group I: SurveillanceActive Control1 Intervention
Group II: DurvalumabActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials
135
Recruited
70,300+

AstraZeneca

Industry Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Findings from Research

Durvalumab is an FDA-approved monoclonal antibody that enhances T-cell responses against cancer by blocking the PD-L1 pathway, specifically for patients with advanced urothelial carcinoma who have progressed after platinum-based chemotherapy.
The drug is currently being tested in phase III trials for various cancers, including lung and head and neck cancers, indicating its potential broad application in oncology beyond urothelial carcinoma.
Durvalumab: First Global Approval.Syed, YY.[2022]
In a study of patients with metastatic urothelial carcinoma, treatment with durvalumab led to significant improvements in health-related quality of life (HRQOL) and disease-related symptoms, as measured by the FACT-Bl and EORTC QLQ-C30 questionnaires.
The improvements in patient-reported outcomes were correlated with better tumor shrinkage and reductions in inflammatory biomarkers, suggesting that durvalumab not only helps manage cancer symptoms but may also positively influence systemic inflammation.
Patient-reported outcomes and inflammatory biomarkers in patients with locally advanced/metastatic urothelial carcinoma treated with durvalumab in phase 1/2 dose-escalation study 1108.O'Donnell, PH., Arkenau, HT., Sridhar, SS., et al.[2021]
Durvalumab, a PD-L1 inhibitor, has been shown to be safe for patients with various solid tumors, with common side effects including pruritus and fatigue, based on a meta-analysis of 17 studies involving 1,529 patients.
Higher levels of PD-L1 expression in tumors are linked to better treatment responses to durvalumab, indicating that PD-L1 could serve as a useful biomarker for predicting the drug's efficacy.
Safety and efficacy of durvalumab (MEDI4736) in various solid tumors.Yang, H., Shen, K., Zhu, C., et al.[2022]

References

Durvalumab: First Global Approval. [2022]
Patient-reported outcomes and inflammatory biomarkers in patients with locally advanced/metastatic urothelial carcinoma treated with durvalumab in phase 1/2 dose-escalation study 1108. [2021]
Safety and efficacy of durvalumab (MEDI4736) in various solid tumors. [2022]
Perioperative Chemoimmunotherapy With Durvalumab for Muscle-Invasive Urothelial Carcinoma: Primary Analysis of the Single-Arm Phase II Trial SAKK 06/17. [2023]
FDA Approves First Agent to Treat Locally Advanced, Metastatic Urothelial Cancer. [2023]
Adverse Events and Tolerability of Combined Durvalumab and Tremelimumab versus Durvalumab Alone in Solid Cancers: A Systematic Review and Meta-Analysis. [2023]
A Randomized Phase II Study of MEDI0680 in Combination with Durvalumab versus Nivolumab Monotherapy in Patients with Advanced or Metastatic Clear-cell Renal Cell Carcinoma. [2023]
Primary results of STRONG: An open-label, multicenter, phase 3b study of fixed-dose durvalumab monotherapy in previously treated patients with urinary tract carcinoma. [2022]
Safety and Efficacy of Durvalumab (MEDI4736), an Anti-Programmed Cell Death Ligand-1 Immune Checkpoint Inhibitor, in Patients With Advanced Urothelial Bladder Cancer. [2022]