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Checkpoint Inhibitor

Durvalumab +/- Tremelimumab for Prostate Cancer

Phase 2
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be surgically or medically castrated with testosterone levels of < 50 ng/dL
ECOG performance status 0 or 1
Must not have
Patients with brain metastases
Patients with untreated and/or uncontrolled cardiovascular conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer drug, either alone or with another drug. They want to see what effects it has and what side effects it causes.

Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to castration and has progressed despite treatment. They must have tried treatments like abiraterone or enzalutamide, can't have had certain immune therapies before, and need functioning major organs. No brain metastases or serious autoimmune diseases in the last 3 years, except for some exceptions like stable thyroid conditions.
What is being tested?
The trial is testing Durvalumab alone versus its combination with Tremelimumab on metastatic castration-resistant prostate cancer. It aims to understand their effects on this cancer type and monitor any side effects from these drugs when used separately or together.
What are the potential side effects?
Possible side effects include immune-related reactions affecting different organs, infusion reactions similar to allergic responses during drug administration, potential aggravation of pre-existing autoimmune diseases, and other common symptoms associated with immunotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My testosterone levels are below 50 ng/dL due to treatment.
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I am fully active or can carry out light work.
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My cancer has worsened, shown by increasing PSA levels or by scans.
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My prostate cancer is resistant to hormone therapy.
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I have a tumor sample available for testing.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have cancer that has spread to my brain.
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I have heart conditions that haven't been treated or controlled.
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I am currently receiving treatment for another cancer.
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I am not currently on any experimental drugs or cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate Measured by RECIST 1.1
Objective Response Rate by iRECIST
Secondary study objectives
Prostate-specific Antigen (PSA) Response Rate
Time to Objective Disease Progression

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Anorexia
30%
Constipation
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Cough
15%
Abdominal Pain
15%
Back pain
15%
Increased Urinary Frequency
15%
Weight gain
13%
Arthralgia
10%
Dizziness
10%
Anxiety
10%
Bladder infection
10%
Nasal congestion
10%
Vaginal discharge
8%
Colitis
8%
Dry mouth
8%
Dry skin
8%
Fever
8%
Anal pain
8%
Edema limbs
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Small intestinal obstruction
8%
Thromboembolic event
8%
Urinary frequency
8%
Urinary tract pain
5%
Confusion
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Anemia
5%
Ascites
5%
Gastroesophageal reflux disease
5%
Hypomagnesemia
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Rash acneiform
5%
Sinus bradycardia
5%
Upper respiratory infection
5%
Urinary urgency
5%
Vaginal hemorrhage
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Colonic perforation
3%
Dysarthria
3%
Blood bilirubin increased
3%
CPK increased
3%
Creatinine increased
3%
Myositis
3%
Rectal hemorrhage
3%
Hypothyroidism
3%
Left ventricular systolic dysfunction
3%
Lethargy
3%
Muscle weakness left-sided
3%
Myocarditis
3%
Rectal pain
3%
Weight Loss
3%
Fall
3%
Generalized muscle weakness
3%
Hyperglycemia
3%
Hyperkalemia
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Pleural effusion
3%
Skin infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B - Durvalumab aloneExperimental Treatment1 Intervention
Durvalumab-IV for 60 minutes day 1 every 4 weeks
Group II: Arm A - Durvalumab plus TremelimumabExperimental Treatment2 Interventions
Durvalumab-IV for 60 minutes day 1 every 4 weeks Tremelimumab-IV every 60 minutes day 1, cycles 1-4
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3750
Tremelimumab
2017
Completed Phase 2
~3070

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupLead Sponsor
132 Previous Clinical Trials
69,815 Total Patients Enrolled
9 Trials studying Prostate Cancer
6,851 Patients Enrolled for Prostate Cancer
AstraZenecaIndustry Sponsor
4,397 Previous Clinical Trials
289,121,604 Total Patients Enrolled
56 Trials studying Prostate Cancer
25,431 Patients Enrolled for Prostate Cancer
Sebastien HotteStudy ChairJuravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON Canada
4 Previous Clinical Trials
310 Total Patients Enrolled
2 Trials studying Prostate Cancer
268 Patients Enrolled for Prostate Cancer
~6 spots leftby Nov 2025
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