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Trial record 1 of 1 for:    NCT06018116
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A Canadian Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer. (CANUCK-01)

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ClinicalTrials.gov Identifier: NCT06018116
Recruitment Status : Not yet recruiting
First Posted : August 30, 2023
Last Update Posted : September 8, 2023
Sponsor:
Collaborator:
Cancer Research Society
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

Study Description
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Brief Summary:
This is a Phase II, multi-center, placebo-controlled randomized controlled trial of standard of care (SOC) avelumab versus SOC avelumab with bicalutamide for patients with metastatic or locally advanced urothelial carcinoma.

Condition or disease Intervention/treatment Phase
Metastatic Urothelial Carcinoma Drug: Bicalutamide 150 mg Drug: Placebo Phase 2

Detailed Description:

Urothelial carcinoma (UC) is the second most common urological cancer after prostate cancer. Non-muscle invasive bladder cancer (NMIBC) is the most common form (~75%). Muscle-invasive bladder cancer (MIBC) is found at presentation in ~25% of patients, with 10-20% of NMIBC eventually becoming MIBC. Risk groups for NMIBC are based on number of tumours, stage and size. Almost half of patients with MIBC eventually progress to metastatic disease.

Treatments for metastatic urothelial carcinoma (mUC) have evolved rapidly over the last several years. Pembrolizumab demonstrated benefit as second line therapy for locally advanced and metastatic UC. Subsequently, the landmark Phase III randomized JAVELIN trial showed that the addition of avelumab as maintenance therapy following a response to chemotherapy for mUC significantly prolonged overall survival relative to best supportive care (hazard ratio (HR) = 0.69; 95% confidence interval (CI), 0.56-0.86; P = 0.001). Overall survival and progression-free survival were 21.4 months (18.9 to 26.1) and 5.5 (4.2 to 7.2) months, respectively. This trial established avelumab as the SOC treatment and initial immunotherapy for mUC following chemotherapy.

The investigators have selected a double-blind placebo-controlled randomized study design to be able to assess the pragmatic endpoint of investigator-assessed clinical progression. Randomization will assign patients 2:1 to bicalutamide 150mg daily plus SOC avelumab or placebo plus SOC avelumab. Patients will be followed every 3 months after avelumab treatment has started and until progression.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Canadian Phase II, Placebo-controlled Randomized Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer.
Estimated Study Start Date : October 2023
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Bicalutamide
standard of care (SOC) avelumab with 150mg daily oral bicalutamide
 Drug: Bicalutamide 150 mg
nonsteroidal antiandrogen
Other Name: standard of care avelumab
Placebo Comparator: Placebo
standard of care (SOC) avelumab with daily oral placebo
 Drug: Placebo
placebo
Other Name: standard of care avelumab


Outcome Measures
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Primary Outcome Measures :
  1. Rate of bladder tumor recurrence [ Time Frame: 30 months ]
    The primary outcome will be to the time to investigator-assessed progression on avelumab therapy.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 or greater and able to provide informed consent for the trial;
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening;
  3. Patients with histologically confirmed urothelial carcinoma;
  4. Patients is a candidate for a course of maintenance avelumab treatment for metastatic or locally advanced urothelial carcinoma;
  5. Male patients with partners of child-bearing potential must agree to 2 acceptable forms of birth control and be continued for at least 130 days after study drug is discontinued.

Exclusion Criteria:

  1. Patients with a history of liver disease whose hepatic enzymes, alkaline phosphatase or bilirubin are greater than twice the upper limit of normal will be ineligible.
  2. Patients with neutrophils (< 1,000/μL) will be ineligible.
  3. Patients on androgen replacement therapy, or those with prostate cancer or other diseases currently treated with systemic hormonal therapy will be ineligible for study enrollment. Patients receiving 5-alpha reductase inhibitors will not be excluded.
  4. Patients who have a concurrent malignancy other than UC within the past years for which treatment is planned within the next 6 months.
  5. Patients taking an investigational drug within 2 weeks of enrollment into this study.
  6. Patients receiving or planning to receive coumadin therapy.
  7. Female patients with childbearing potential are excluded due to known teratogenic effects of bicalutamide.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06018116


Contacts
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Contact: Paul Toren, MD, PhD, FRCSC 418-525-4444 ext 17064 paul.toren@crchudequebec.ulaval.ca

Locations
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Canada
CHU de Québec - Université Laval
Québec, Canada, G1G 5X1
Contact: Paul Toren, MD, PhD    418-525-4444 ext 17064    paul.toren@crchudequebec.ulaval.ca   
Contact: Catherine Gérard, PhD    418-525-4444 ext 67704    catherine.gerard@crchudequebec.ulaval.ca   
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Cancer Research Society
Investigators
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Study Chair: Paul Toren, MD, PhD, FRCSC CHU de Québec - Université Laval
More Information
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Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT06018116    
Other Study ID Numbers: MP-20-2024-6963
First Posted: August 30, 2023    Key Record Dates
Last Update Posted: September 8, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by CHU de Quebec-Universite Laval:
bicalutamide
avelumab
Additional relevant MeSH terms:
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Carcinoma, Transitional Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Avelumab
Bicalutamide
Antibodies, Monoclonal
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists