← Back to Search

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
Select...
My testosterone levels are below 50 ng/dL due to treatment.
Select...
I am fully active or can carry out light work.
Select...
My cancer has worsened, shown by increasing PSA levels or by scans.
Select...
My prostate cancer is resistant to hormone therapy.
Select...
I have a tumor sample available for testing.
Select...
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
124 Previous Clinical Trials
67,401 Total Patients Enrolled
10 Trials studying Prostate Cancer
7,083 Patients Enrolled for Prostate Cancer
AstraZenecaIndustry Sponsor
4,259 Previous Clinical Trials
288,593,850 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

Frequently Asked Questions

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

Has the FDA cleared Durvalumab for public use?

"There is only some data supporting the safety of Durvalumab, as this treatment is still in Phase 2 trials. This means that while there are no reports proving its efficacy, there have been promising indications of Durvalumab's safety."

Answered by AI

Is this trial taking place in more than one state?

"There are 11 clinical trial sites currently operational for this trial, including the BCCA - Cancer Centre for the Southern Interior in Kelowna, Juravinski Cancer Centre at Hamilton Health Sciences in Hamilton, and BCCA - Vancouver Cancer Centre in Vancouver."

Answered by AI

For what purpose is Durvalumab most commonly prescribed?

"Durvalumab is a medication used to treat unresectable stage iii non-small cell lung cancer. However, it has also been shown to be effective in treating other conditions such as previously untreated, metastatic ureter urothelial carcinoma and advance directives."

Answered by AI

Are researchers looking for more participants at this time?

"According to the information available on clinicaltrials.gov, this particular study is not currently looking for patients as it has already collected all of the data that it needs. Thestudy was originally posted on August 18th, 2016 and was last updated on March 14th, 2022. Even though this study doesn't need any more participants, there are 1,712 other studies that do."

Answered by AI

What are some other ways in which Durvalumab has been studied?

"There are a total of 345 active clinical trials for Durvalumab, with the majority of these (51) being Phase 3 studies. The town of Cordoba in Texas has the largest number of trials for this medication, but there are 13051 locations worldwide where researchers are studying Durvalumab."

Answered by AI

How many participants are being accepted into this experiment?

"Unfortunately, this specific trial is no longer looking for new participants. It was initially posted on 8/18/2016 and received its last update on 3/14/2022. However, there are presently 1367 studies actively recruiting participants with prostate cancer and 345 studies for Durvalumab actively recruiting patients."

Answered by AI

What other similar trials have been conducted in the past?

"Clinical trials for Durvalumab began over a decade ago in 2007. After the first Phase 1 trial with 37 patients, AstraZeneca sponsored a second Phase 2 study that resulted in drug approval. Now, across 58 countries and 1325 cities, there are 345 ongoing clinical trials involving Durvalumab."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Durvalumab With or Without Tremelimumab in Metastatic Castration Resistant Prostate Cancer
2016. "Durvalumab With or Without Tremelimumab in Metastatic Castration Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02788773.
~6 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top