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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.
Must not have
Any concurrent chemotherapy, IP, biologic or hormonal therapy for cancer treatment
Experienced an immune-mediated or non-immune-mediated toxicity that led to permanent discontinuation of durvalumab in parent clinical study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tumor assessments as determined by the investigator (at least every 12 weeks) until withdrawal of consent, progression or death; approximately 30 months
Awards & highlights

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not currently on any cancer treatments like chemotherapy or hormone therapy.
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I stopped taking durvalumab due to a severe side effect.
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I have been diagnosed with a new cancer since joining the original study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tumor assessments as determined by the investigator (at least every 12 weeks) until withdrawal of consent, progression or death; approximately 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and tumor assessments as determined by the investigator (at least every 12 weeks) until withdrawal of consent, progression or death; approximately 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary study objectives
Cohort 2: Duration of Response (DOR)
Cohort 2: Overall Response Rate (ORR)
Number of Participants Who Were Alive

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

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
~3840

Find a Location

Who is running the clinical trial?

ParexelIndustry Sponsor
308 Previous Clinical Trials
100,988 Total Patients Enrolled
Medidata SolutionsIndustry Sponsor
21 Previous Clinical Trials
10,153 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
~27 spots leftby Sep 2025
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