A trial to learn how safe durvalumab with chemotherapy is and how well it works in adults with muscle-invasive bladder cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-05-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AstraZeneca

External identifiers

EU CT number

2024-519246-75-01

ClinicalTrials.gov

NCT06960577

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To assess the safety of neoadjuvant durvalumab combined with ddMVAC prior to RC.

Secondary objectives 6

1. To further assess the safety and tolerability of perioperative durvalumab combined with neoadjuvant chemotherapy.
2. To assess the efficacy of perioperative durvalumab combined with ddMVAC in terms of EFS.
3. To assess the efficacy of perioperative durvalumab combined with ddMVAC in terms of DFS.
4. To assess the efficacy of perioperative durvalumab combined with ddMVAC in terms of OS.
5. To assess the efficacy of neoadjuvant durvalumab combined with ddMVAC followed by RC in terms of pCR.
6. To assess the efficacy of neoadjuvant durvalumab combined with ddMVAC followed by RC in terms of pDS.

Conditions and MedDRA coding

Patients With Muscle-Invasive Bladder Cancer

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 or T1N1M0 with transitional cell histology
2. Patients must be planning to undergo a radical cystectomy at the time of randomization;
3. An ECOG performance status of 0 or 1 at enrolment.
4. Must have a life expectancy of at least 12 weeks at first dose of study medication.
5. Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC

Exclusion criteria 4

1. Evidence of lymph node involvement (N2-N3) or metastatic disease at the time of screening.
2. Requires immunosuppression medication for a concomitant condition.
3. Contra-indication to any of the study drugs.
4. Active or prior documented autoimmune or inflammatory disorders (exceptions apply)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of Grade 3 or 4 PRAEs as observed prior to RC. A PRAE is defined as an AE that has been assessed by the investigator to be possibly related to study treatment.

Secondary endpoints 6

1. Incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality of treatment-emergent AEs, including PRAEs, AESIs, imAEs, AEs, and SAEs; AEs resulting in study treatment interruption and discontinuation; laboratory findings.
2. EFS is defined as the time from first neoadjuvant durvalumab + ddMVAC treatment until the earliest occurrence of any of the following events: • First recurrence of disease after RC • First documented progression in participants who were medically precluded from RC • Time of expected surgery in participants who refuse to undergo RC or failure to undergo RC in participants with residual disease
3. DFS is defined as the time from the date of RC to the earliest of the first recurrence of disease post RC or death due to any cause. The primary measures of interest are DFS rates at 18 and 24 months.
4. OS is defined as the time from first neoadjuvant durvalumab + ddMVAC until death due to any cause. The primary measure of interest is OS rate at 12 months.
5. pCR rate is defined as the proportion of participants whose pathologic staging is T0N0M0 as assessed per local pathology review using specimens obtained via RC. Participants who do not undergo RC will be included as failures (did not achieve T0N0M0).
6. pDS rate is defined as the proportion of participants whose pathologic staging is < P2 per local pathology review using specimens obtained via RC.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Third parties 1

Locations

4 EU/EEA countries · 35 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 30 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications