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Checkpoint Inhibitor

Durvalumab for Tumors

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

Study Summary

This trial is testing a new immunotherapy treatment to see if it can help people with this disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months 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 version 1.1
Secondary outcome measures
Number and severity of adverse events
Progression free survival based on Kaplan-Meier method
Response duration , based on Kaplan-Meier method
+1 more

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

1Treatment groups
Experimental Treatment
Group I: Durvalumab + TremelimumabExperimental Treatment2 Interventions
Durvalumab 1500 mg IV 60 min Day 1 every 4 weeks Tremelimumab 75 mg IV 60 min Day 1, cycles 1-4
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
2017
Completed Phase 2
~3380
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,313 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,271 Previous Clinical Trials
288,612,719 Total Patients Enrolled
6 Trials studying Tumors
1,866 Patients Enrolled for Tumors
Abha GuptaStudy ChairHospital for Sick Children, Toronto ON Canada

Frequently Asked Questions

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

Is Durvalumab known to cause any serious side effects?

"Durvalumab has not yet been proven effective, however, there is some evidence supporting its safety which earned it a score of 2."

Answered by AI

What are the primary indications for Durvalumab?

"Durvalumab is a treatment option for patients with unresectable stage iii non-small cell lung cancer, metastatic ureter urothelial carcinoma, and those that have not received prior treatments."

Answered by AI

What other scientific investigations have included Durvalumab in their research?

"Originally, durvalumab was studied in 2007 at Research Site. To date, there have been 123 completed trials with 345 more presently underway; a large number of these are located in Vancouver, BC."

Answered by AI

How many research facilities are conducting this clinical trial?

"In addition to Vancouver, British Columbia, London, Ontario, and Edmonton, Alberta; this study is also enrolling at 13 other locations across Canada."

Answered by AI

Are investigators still looking for new participants for this research project?

"The clinicaltrial.gov website provides information indicating that this study is not currently looking for new patients to enroll. Although the most recent update was on January 25th, 2022, the trial originally started on October 19th, 2016. There are 346 other trials which are still recruiting patients right now."

Answered by AI

How many people are being asked to take part in this experiment?

"This study has completed recruitment for participants. The trial was first posted on October 19th, 2016 and last updated on January 25th, 2022. If you are interested in other studies, there is currently one study seeking patients with advanced rare tumours and 345 trials for Durvalumab that are admitting patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Durvalumab and Tremelimumab in Patients With Advanced Rare Tumours
2016. "Durvalumab and Tremelimumab in Patients With Advanced Rare Tumours". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02879162.
~16 spots leftby Apr 2025
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