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Checkpoint Inhibitor
MEDI4736 (Durvalumab) + Tremelimumab for Solid Tumors (STRONG Trial)
Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have a life expectancy of at least 12 weeks.
Age ≥18 years at the time of screening. For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening to final data cutoff (maximum up to 4 years) following date of first patient treatment initiation.
Awards & highlights
STRONG Trial Summary
This trial is testing the safety and effectiveness of a combination of two drugs, or one drug by itself, to treat different types of solid tumors.
Eligible Conditions
- Solid Tumors
STRONG Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSTRONG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening to final data cutoff (maximum up to 4 years) following date of first patient treatment initiation.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening to final data cutoff (maximum up to 4 years) following date of first patient treatment initiation.
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 of Special Interest (AESIs)
Secondary outcome measures
Number of Participants With Adverse Events
Overall Survival
Side effects data
From 2022 Phase 3 trial • 867 Patients • NCT0308447126%
Asthenia
20%
Anaemia
20%
Constipation
17%
Decreased appetite
16%
Diarrhoea
15%
Nausea
13%
Pruritus
10%
Urinary tract infection
10%
Cough
10%
Fatigue
9%
Vomiting
9%
Dyspnoea
9%
Back pain
9%
Oedema peripheral
9%
Pyrexia
7%
Haematuria
7%
Abdominal pain
7%
Arthralgia
7%
Hypothyroidism
6%
Blood creatinine increased
5%
Weight decreased
2%
Sepsis
1%
Pneumonia
1%
Tumour hyperprogression
1%
General physical health deterioration
1%
Death
1%
Acute kidney injury
1%
Pyelonephritis
1%
Device related infection
1%
Urosepsis
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab
STRONG Trial Design
2Treatment groups
Experimental Treatment
Group I: MonotherapyExperimental Treatment1 Intervention
Monotherapy (Durvalumab 1,500 mg): Patients will receive durvalumab 1,500 mg via IV infusion Q4W on Week 0.
Group II: Combination therapyExperimental Treatment2 Interventions
Combination therapy (durvalumab + tremelimumab) : Patients will receive the combination therapy followed by monotherapy via intravenous (IV) infusion once Q4W:
Durvalumab 1,500 mg + tremelimumab 75 mg on Week 0, for up to a maximum of 4 doses (or cycles) and
Durvalumab 1,500 mg starting 4 weeks after the last infusion of the combination or discontinuation of tremelimumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEDI4736 (Durvalumab)
2017
Completed Phase 3
~940
MEDI4736 (Durvalumab) + Tremelimumab
2017
Completed Phase 3
~870
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,243 Previous Clinical Trials
288,524,905 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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