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Checkpoint Inhibitor

Durvalumab + Tremelimumab + Enfortumab Vedotin for Bladder Cancer (VOLGA Trial)

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC

Participants with MIBC clinical tumor (T) stage T2-T4aN0/1M0 or UC of the bladder with clinical state T1N1M0

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 5 years

Awards & highlights

VOLGA Trial Summary

This trial is designed to study the efficacy and safety of Durvalumab in combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in combination with Enfortumab Vedotin compared to SOC in patients ineligible for Cisplatin or who refuse Cisplatin undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer.

Who is the study for?

This trial is for adults with muscle invasive bladder cancer who can't use or refuse cisplatin, haven't had chemo or immunotherapy for it, and are fit enough for cystectomy surgery. They must have a life expectancy of at least 12 weeks and be able to provide a tumor sample.Check my eligibility

What is being tested?

The study tests Durvalumab combined with Tremelimumab and Enfortumab Vedotin versus Durvalumab with Enfortumab Vedotin alone in patients undergoing surgery. It's randomized, meaning treatment is assigned by chance, aiming to improve current treatments.See study design

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, infusion-related symptoms like fever or chills, fatigue, skin issues, potential liver problems (hepatitis), and an increased risk of infections.

VOLGA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not had chemotherapy or immunotherapy for my bladder cancer.

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My bladder cancer is at a specific stage but hasn't spread far.

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I have not had chemotherapy or immunotherapy for bladder cancer.

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer is of a type that involves certain cells in the bladder or urinary tract.

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My bladder cancer is confirmed by lab tests and is invasive.

Select...

I cannot take cisplatin or have chosen not to, as noted in my medical records.

Select...

I am healthy enough for bladder removal surgery and can undergo treatment before surgery.

VOLGA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in WHO/ECOG performance status (Safety Run-In part)

Compare efficacy of durvalumab + tremelimumab + EV relative to cystectomy alone on EFS (Safety Run-In and Main Study)

Compare efficacy of durvalumab + tremelimumab + EV relative to cystectomy alone on pCR rate (Safety Run-In and Main Study)

+10 more

Secondary outcome measures

1.Pathologic complete response (pCR) rates at time of cystectomy in Arm 2 vs Arm 3 (Safety Run-In and Main Study)

10.Immunogenicity of durvalumab when used in combination with Tremelimumab as measured by presence of antidrug antibodies (ADA) (Main Study part)

11.Area under the Plasma Concentration versus Time Curve (AUCτ) of durvalumab and tremelimumab (Main Study part)

+10 more

VOLGA Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Durvalumab + Tremelimumab + Enfortumab vedotinExperimental Treatment4 Interventions

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.

Group II: Durvalumab + Enfortumab vedotinExperimental Treatment3 Interventions

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.

Group III: Cystectomy with or without approved Adjuvant Therapy.Active Control1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

Tremelimumab

2017

Completed Phase 2

~3380

Radical Cystectomy

2006

Completed Phase 2

~140

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,266 Previous Clinical Trials

288,605,152 Total Patients Enrolled

Media Library

Durvalumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04960709 — Phase 3

Bladder Cancer Research Study Groups: Durvalumab + Tremelimumab + Enfortumab vedotin, Durvalumab + Enfortumab vedotin, Cystectomy with or without approved Adjuvant Therapy.

Bladder Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04960709 — Phase 3

Durvalumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04960709 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the general consensus in the medical community surrounding Enfortumab Vedotin?

"Santa Monica, California is home to a large number of the 362 active clinical trials studying enfortumab vedotin, which was first researched in 2007 at Research Site. Out of the total 314 completed studies, many have been conducted out of Santa Monica."

Answered by AI

Is this study also taking place in different states within the US?

"There are 26 active clinical trial sites for this medication, which can be found in Santa Monica, Brooklyn, Fort Myers and many other locations. By selecting the site nearest to you, you can help reduce travel-related costs or inconvenience."

Answered by AI

Does this clinical trial set a precedent?

"Enfortumab Vedotin has a long clinical history, with the first drug trial occurring in 2007. This initial study was sponsored by AstraZeneca and only involved 37 patients. After this Phase 2 approval in 2007, there are now 362 active studies involving Enfortumab Vedotin across 58 countries and 1481 cities."

Answered by AI

In order to participate in this research, do patients have to be a certain age?

"The age limit for participants in this clinical trial is 130 years. All candidates must also be adults, meaning that they should be older than 18 years of age."

Answered by AI

Are there any guidelines limiting how many people can be in this experiment at one time?

"That's accurate. The most recent information available on clinicaltrials.gov shows that this study is still recruiting patients. 26 hospitals are participating in the trial, and 830 people are needed for the study in total."

Answered by AI

Is Enfortumab Vedotin more likely to cause harm than other cancer treatments?

"Enfortumab Vedotin's safety is estimated to be a 3. This evaluation comes from the fact that Enfortumab Vedotin is in Phase 3 trials, which suggests that not only is there some data affirming its efficacy, but also multiple rounds of research highlighting its safety."

Answered by AI

What is the main purpose of Enfortumab Vedotin?

"Enfortumab Vedotin is not only used to treat advance directives, but also other conditions like pharmacotherapy, malignant neoplasms, and disease."

Answered by AI

Are researchers looking for more participants in this trial?

"That is correct. The clinical trial, which began recruiting on 10/20/2017, is still looking for 830 participants across 26 sites according to the most recent update on 11/8/2022."

Answered by AI

Which type of patient does this research require?

"This study is looking for 830 participants who currently have malignant neoplasms and meet the following criteria: Participants with MIBC clinical tumor (T) stage T2-T4aN0/1M0 or UC of the bladder with clinical state T1N1M0, Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC, Availability of tumor sample prior to study entry, Must have a life expectancy of at least 12 weeks at randomization, Cisplatin-ineligible, as defined by any of the following criteria (based on Galsky et al 2011)"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04960709.

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