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Durvalumab for Cancer (WAVE Trial)

Phase 4
Waitlist Available
Led By Jared Weiss, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient received durvalumab monotherapy and/or durvalumab containing combination in an AstraZeneca/MedImmune-sponsored parent clinical study that is approved for enrollment into this study.
Patient must be 18 years or older, at the time of signing the ICF. For subjects aged < 20 years and enrolled in Japan, a written ICF should be obtained from the subject and his or her legally acceptable representative.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

WAVE Trial Summary

This trial will help researchers understand the long-term safety of durvalumab and how well it works against cancer.

Who is the study for?
This trial is for adults who've previously received durvalumab alone or with other treatments in a related study. They must be able to consent and follow the trial's procedures. People can't join if they're on other cancer therapies, had severe reactions leading to durvalumab discontinuation, developed new cancers since the first study, or are in another interventional trial.Check my eligibility
What is being tested?
The focus of this study is on long-term safety and effectiveness of durvalumab for treating solid tumors. It offers ongoing treatment or re-treatment with durvalumab and collects data on patient survival over time.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects such as inflammation in various organs, infusion reactions similar to allergic responses, fatigue, potential lung issues (pneumonitis), thyroid disorders, and skin conditions.

WAVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been treated with durvalumab alone or in combination as part of an AstraZeneca study.
Select...
I am 18 or older and can sign the consent form myself.
Select...
I have finished or stopped all cancer treatments except for durvalumab.

WAVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Number of participants with adverse events as assessed by Common Toxicity Criteria for Adverse Events (CTCAE v5.0)
Secondary outcome measures
Efficacy of durvalumab in terms of Duration of Response (DOR) in patients who undergo retreatment with durvalumab
Efficacy of durvalumab in terms of Overall Response Rate (ORR) in patients who undergo retreatment with durvalumab
Overall Survival (OS)

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

WAVE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Durvalumab Monotherapy
Group II: Off TreatmentActive Control1 Intervention
Follow up Only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

ParexelIndustry Sponsor
303 Previous Clinical Trials
100,663 Total Patients Enrolled
Medidata SolutionsIndustry Sponsor
20 Previous Clinical Trials
9,848 Total Patients Enrolled
CISCRPUNKNOWN

Media Library

Durvalumab Clinical Trial Eligibility Overview. Trial Name: NCT04078152 — Phase 4
Solid Tumors Research Study Groups: Off Treatment, Treatment
Solid Tumors Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04078152 — Phase 4
Durvalumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04078152 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Durvalumab Long-Term Safety and Efficacy Study
2019. "Durvalumab Long-Term Safety and Efficacy Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04078152.
All > Immunotherapy
~14 spots leftby Sep 2024
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