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Cancer Vaccine

Durvalumab + BCG for Bladder Cancer (POTOMAC Trial)

Q: What conditions does Bacillus Calmette-Guerin (BCG) vaccine help to prevent?

<p>BCG is commonly used to treat stage III non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a> that cannot be surgically removed. Additionally, it is sometimes used to address other issues such as metastatic ureter urothelial carcinoma or advance directives.</p>

Phase 3

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Aged at least 18 years

Local histological confirmation (based on pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa. A high risk tumor is defined as one of the following: T1 tumor, High grade/ G3 tumor, CIS, Multiple and recurrent and large (with diameter of largest tumor ≥3 cm) tumors (all conditions must be met in this point)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

POTOMAC Trial Summary

This trial is testing a new combination therapy for patients with a type of bladder cancer that has not spread to muscle. The study will compare the new therapy to the current standard of care to see if it is more effective and has fewer side effects.

Who is the study for?

This trial is for adults with high-risk non-muscle-invasive bladder cancer who haven't had immune therapy or BCG for bladder cancer, and no recent immunosuppressants. It's not for those with muscle-invasive or advanced cancer, certain autoimmune diseases, or a history of other cancers (with some exceptions).Check my eligibility

What is being tested?

The study tests Durvalumab combined with BCG against standard BCG treatment alone in patients with bladder cancer that hasn't invaded the muscle layer. The goal is to see if adding Durvalumab improves outcomes.See study design

What are the potential side effects?

Durvalumab may cause immune-related side effects like inflammation in various organs, skin reactions, hormone gland problems (like thyroid issues), and could worsen pre-existing autoimmune conditions.

POTOMAC Trial Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My bladder cancer is high-risk but hasn't spread beyond the inner layers.

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I have not had radiation therapy for bladder cancer.

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I have not received any immune therapy for cancer, including vaccines.

POTOMAC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 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

The efficacy of Durvalumab + BCG (induction plus maintenance) combination therapy compared to SoC in terms of Disease free survival (DFS) in patients with NMIBC

Secondary outcome measures

Disease-related symptoms and HRQoL in patients with NMIBC treated with Durvalumab + BCG combination therapies compared to SoC and compared to each other using the EORTC QLQ-C30 questionnaire

Disease-related symptoms and HRQoL in patients with NMIBC treated with Durvalumab + BCG combination therapies compared to SoC and compared to each other using the the EORTC QLQ NMIBC24 questionnaire

Patient-reported treatment tolerability using specific PRO CTCAE symptoms

+12 more

Other outcome measures

Number of treatment-related adverse events as assessed by CTCAE v4.0 in patients receiving Durvalumab + BCG combination therapies compared to SoC

Side effects data

From 2022 Phase 2 trial • 20 Patients • NCT04507126

25%

Post Lumbar Puncture Headache

19%

Back pain

13%

Fatigue

13%

Intermittent headache

Increased stress

Removal of squamous cell carcinoma

Hematoma at blood draw site

Contact dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

BCG Immunization

POTOMAC Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Durvalumab plus BCG (induction only)Experimental Treatment2 Interventions

Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy

Group II: Durvalumab plus BCG (induction + maintenance)Experimental Treatment2 Interventions

Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy

Group III: BCG treatment (Standard of care therapy)Active Control1 Intervention

Bacillus Calmette-Guerrin (BCG) standard of care treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab (MEDI4736)

2018

Completed Phase 2

~50

Bacillus Calmette-Guerin (BCG)

2021

Completed Phase 2

~50

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,257 Previous Clinical Trials

288,592,768 Total Patients Enrolled

Media Library

Bacillus Calmette-Guerin (BCG) (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03528694 — Phase 3

Bladder Cancer Research Study Groups: BCG treatment (Standard of care therapy), Durvalumab plus BCG (induction only), Durvalumab plus BCG (induction + maintenance)

Bladder Cancer Clinical Trial 2023: Bacillus Calmette-Guerin (BCG) Highlights & Side Effects. Trial Name: NCT03528694 — Phase 3

Bacillus Calmette-Guerin (BCG) (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03528694 — Phase 3

Frequently Asked Questions

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

Where are the medical facilities that are participating in this research project?

"There are 6 sites conducting this study, with locations in Hamilton, Toronto, and Quebec. Additionally, there are 6 other locations that have yet to be announced. It is in the best interest of patients to enroll at the site closest to them to limit travel."

Answered by AI

What has been the medical community's experience with Bacillus Calmette-Guerin (BCG) in terms of previous clinical trials?

"There are a total of 338 ongoing clinical trials for Bacillus Calmette-Guerin (BCG), with the majority of these studies being in Phase 3. Out of the 51 Phase 3 trials, the majority are taking place in Wakayama-shi, Texas. However, there are 12902 locations running clinical trials for Bacillus Calmette-Guerin (BCG) in total."

Answered by AI

If I join this clinical trial, what are the benefits that I could experience?

"This study is looking for 18-130 year old patients that have had a recent resection for Ta/T1 papillary bladder cancer. The following criteria must also be met: no prior exposure to immune-mediated therapy, no prior radiation for bladder cancer, aged at least 18 years, BCG-naïve, multiple and recurrent tumors with a diameter of ≥3 cm."

Answered by AI

What conditions does Bacillus Calmette-Guerin (BCG) vaccine help to prevent?

"BCG is commonly used to treat stage III non-small cell lung cancer that cannot be surgically removed. Additionally, it is sometimes used to address other issues such as metastatic ureter urothelial carcinoma or advance directives."

Answered by AI

Does this research require subjects to be 20 or older?

"The age parameters for this study are much broader than average, spanning from 18 to 130 years old. In contrast, the average clinical trial has an age limit of 18 or 65+. There are 12 clinical trials that allow patients under 18 to participate and 663 that permit patients over the age of 65."

Answered by AI