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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04960709




Registration number
NCT04960709
Ethics application status
Date submitted
17/06/2021
Date registered
14/07/2021

Titles & IDs
Public title
Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin
Scientific title
A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)
Secondary ID [1] 0 0
2020-005452-38
Secondary ID [2] 0 0
D910PC00001
Universal Trial Number (UTN)
Trial acronym
VOLGA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle Invasive Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Durvalumab
Treatment: Drugs - Tremelimumab
Treatment: Drugs - Enfortumab Vedotin
Treatment: Surgery - Radical Cystectomy

Experimental: Durvalumab + Tremelimumab + Enfortumab vedotin - Participants will receive 3 preoperative 21-day cycles of Durvalumab + Tremelimumab + Enfortumab Vedotin, followed by radical cystectomy, followed by 1 cycle of postoperative Tremelimumab and 9 cycles of Durvalumab. Each postoperative cycle is 28 days.

Experimental: Durvalumab + Enfortumab vedotin - Participants will receive 3 preoperative 21-day cycles of Durvalumab + Enfortumab Vedotin, followed by radical cystectomy, followed by 9 cycles of Durvalumab. Each postoperative cycle is 28 days.

Active comparator: Cystectomy with or without approved Adjuvant Therapy. - Participants may receive SoC (nivolumab approved as adjuvant treatment for MIBC based on high risk criteria) per approved label in the country OR Participants receive standard of care surgery (radical cystectomy) alone.


Treatment: Drugs: Durvalumab
Anti- PD-L1 Antibody

Treatment: Drugs: Tremelimumab
Human IgG2 mAb

Treatment: Drugs: Enfortumab Vedotin
Nectin-4-directed antibody and microtubule inhibitor conjugate

Treatment: Surgery: Radical Cystectomy
For cisplatin-ineligible or cisplatin-refusal patients
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the safety and tolerability as evaluated by adverse events occurring throughout the study (Safety Run-In part)
Timepoint [1] 0 0
At completion of study treatment by the last patient and at 3 months.
Primary outcome [2] 0 0
To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (blood pressure in mmHg) (Safety Run-In part)
Timepoint [2] 0 0
Up to 84 months
Primary outcome [3] 0 0
To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (pulse rate) in beats per minute (Safety Run-In part)
Timepoint [3] 0 0
Up to 84 months
Primary outcome [4] 0 0
To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (respiration rate) in breaths per minute (Safety Run-In part)
Timepoint [4] 0 0
Up to 84 months
Primary outcome [5] 0 0
To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (temperature) in degrees Celsius (Safety Run-In part)
Timepoint [5] 0 0
Up to 84 months
Primary outcome [6] 0 0
To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in clinical chemistry by liver function (Safety Run-In part)
Timepoint [6] 0 0
Up to 84 months
Primary outcome [7] 0 0
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by abnormality in clinical chemistry by kidney function (Safety Run-In part)
Timepoint [7] 0 0
Up to 84 months
Primary outcome [8] 0 0
To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in clinical chemistry by thyroid function (Safety Run-In part)
Timepoint [8] 0 0
Up to 84 months
Primary outcome [9] 0 0
To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in haematology (Safety Run-In part)
Timepoint [9] 0 0
Up to 84 months
Primary outcome [10] 0 0
To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as as assessed by ECG (pulse rate) (Safety Run-In part)
Timepoint [10] 0 0
Up to 84 months
Primary outcome [11] 0 0
Changes in WHO/ECOG performance status (Safety Run-In part)
Timepoint [11] 0 0
Up to 84 months
Primary outcome [12] 0 0
Compare efficacy of durvalumab + tremelimumab + EV (Arm 1) relative to cystectomy (Arm 3) and durvalumab + EV (Arm 2) relative to cystectomy (Arm 3) on EFS (Main Study)
Timepoint [12] 0 0
Up to 3 years
Secondary outcome [1] 0 0
1. To evaluate the efficacy of durvalumab + tremelimumab + EV on pCR rate (Safety Run-in part)
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
2. To evaluate the efficacy of durvalumab + tremelimumab + EV on EFS (Safety Run-in part)
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
3. Pathologic complete response (pCR) rates at time of cystectomy in Arm1 vs Arm3 and Arm 2 vs Arm 3 (Main Study part)
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
4. Overall survival (Safety Run-in and Main Study part)
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [5] 0 0
5. EFS at 24 months (EFS24) (Safety Run-in and Main Study part)
Timepoint [5] 0 0
Up to 24 months
Secondary outcome [6] 0 0
6. Overall survival rate at 5 years (Safety Run-in and Main Study part)
Timepoint [6] 0 0
At 5 years
Secondary outcome [7] 0 0
7. Disease-free survival (DFS) (Safety Run-in and Main Study part)
Timepoint [7] 0 0
Up to first recurrence of disease or death up to 5 years
Secondary outcome [8] 0 0
8. Pathologic downstaging (pDS) rate-to < pT2 (Safety Run-in and Main Study part)
Timepoint [8] 0 0
3 years
Secondary outcome [9] 0 0
9. Disease-specific survival (DSS) (Safety Run-in and Main Study part)
Timepoint [9] 0 0
from randomization until death due to bladder cancer up to 5 year.
Secondary outcome [10] 0 0
10. EORTC QLQ-C30 European Organisation for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire) (Safety Run-in and Main Study part)
Timepoint [10] 0 0
from baseline and time to definitive clinically, assessed up to 5 years
Secondary outcome [11] 0 0
11. Immunogenicity of durvalumab when used in combination with Tremelimumab as measured by presence of antidrug antibodies (ADA) (Safety Run-in and Main Study part)
Timepoint [11] 0 0
At 3 months after last dose of durvalumab and tremelimumab
Secondary outcome [12] 0 0
12. Time to maximum observed serum concentration (tmax) of durvalumab and tremelimumab (Safety Run-in and Main Study part)
Timepoint [12] 0 0
At 3 months after last dose of durvalumab and tremelimumab
Secondary outcome [13] 0 0
13. Metastasis-free survival (MFS) (Safety Run-in and Main Study part)
Timepoint [13] 0 0
From randomization until the first recognition of distant metastases or death, up to approximately 48 months.

Eligibility
Key inclusion criteria
* Histologically or cytologically documented muscle-invasive UC of the bladder.
* Participants with transitional cell and mixed transitional/non-transitional cell histologies;
* Participants with MIBC clinical tumor (T) stage T2-T4aN0/1M0 or UC of the bladder with clinical state T1N1M0 (participants with T1 stage are allowed only with N1 disease)
* Participants should also have not received prior systemic chemotherapy or immunotherapy for the treatment of MIBC or bladder UC.
* Medically fit for cystectomy and able to receive neoadjuvant therapy;
* Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC;
* ECOG performance status of 0,1,2 at enrollment.
* Availability of tumor sample prior to study entry;
* Must have a life expectancy of at least 12 weeks at randomization.
* Cisplatin-ineligible, following criteria based on Galsky et al 2011 OR Refuse cisplatin based chemotherapy (must be documented in the medical records)
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Evidence of lymph node (N2+) or metastatic TCC/UC disease at the time of screening.
* Active infection
* Uncontrolled intercurrent illness
* Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti--PD-1, anti PD-L1, or anti-PD-L2 antibodies.
* Current or prior use of immunosuppressive medication within 14 days before the first dose of IPs.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/09/2028
Actual
Sample size
Target
677
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Country [178] 0 0
Spain
State/province [178] 0 0
Pamplona
Country [179] 0 0
Spain
State/province [179] 0 0
Santander
Country [180] 0 0
Spain
State/province [180] 0 0
Sevilla
Country [181] 0 0
Taiwan
State/province [181] 0 0
Taichung
Country [182] 0 0
Taiwan
State/province [182] 0 0
Tainan
Country [183] 0 0
Taiwan
State/province [183] 0 0
Taipei
Country [184] 0 0
Thailand
State/province [184] 0 0
Bangkok
Country [185] 0 0
Thailand
State/province [185] 0 0
Dusit
Country [186] 0 0
Thailand
State/province [186] 0 0
Songkhla
Country [187] 0 0
Turkey
State/province [187] 0 0
Adana
Country [188] 0 0
Turkey
State/province [188] 0 0
Ankara
Country [189] 0 0
Turkey
State/province [189] 0 0
Antalya
Country [190] 0 0
Turkey
State/province [190] 0 0
Edirne
Country [191] 0 0
Turkey
State/province [191] 0 0
Istanbul
Country [192] 0 0
Turkey
State/province [192] 0 0
Karsiyaka
Country [193] 0 0
Turkey
State/province [193] 0 0
Malatya
Country [194] 0 0
Ukraine
State/province [194] 0 0
Dnipropetrovsk
Country [195] 0 0
Ukraine
State/province [195] 0 0
Dnipro
Country [196] 0 0
Ukraine
State/province [196] 0 0
Kiev
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Blackburn
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Bristol
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Gillingham
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Glasgow
Country [201] 0 0
United Kingdom
State/province [201] 0 0
London
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Sheffield
Country [203] 0 0
Vietnam
State/province [203] 0 0
Ha Noi
Country [204] 0 0
Vietnam
State/province [204] 0 0
Hanoi
Country [205] 0 0
Vietnam
State/province [205] 0 0
Ho Chi Minh city
Country [206] 0 0
Vietnam
State/province [206] 0 0
Ho Chi Minh
Country [207] 0 0
Vietnam
State/province [207] 0 0
Hue

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04960709