← Back to Search

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 below

STRONG Trial 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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening to final data cutoff (maximum up to 4 years) following date of first patient treatment initiation. 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 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 • NCT03084471
26%
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

~112 spots leftby Mar 2025