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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate Measured by RECIST 1.1
Objective Response Rate by iRECIST
Secondary outcome measures
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%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

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
~3870
Tremelimumab
2017
Completed Phase 2
~3380

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupLead Sponsor
126 Previous Clinical Trials
67,990 Total Patients Enrolled
10 Trials studying Prostate Cancer
7,083 Patients Enrolled for Prostate Cancer
AstraZenecaIndustry Sponsor
4,289 Previous Clinical Trials
288,620,146 Total Patients Enrolled
59 Trials studying Prostate Cancer
27,470 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 Jun 2025
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