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PD-L1 Inhibitor
MEDI4736 for Mesothelioma
Phase 2
Waitlist Available
Led By Bryan Burt, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up untreated arm (control): at day 1 after screening, medi4736 + tremelimumab group: at a surgery within one to six weeks after treatment
Awards & highlights
Study Summary
This study is evaluating whether a drug or combination of drugs can improve the immune system in people with mesothelioma.
Eligible Conditions
- Mesothelioma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ untreated group (control): at day 1, medi-4736 and tremelimumab group: at a surgery within one to six weeks after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~untreated group (control): at day 1, medi-4736 and tremelimumab group: at a surgery within one to six weeks after treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Ratio of Intratumoral Cytotoxic T Cells to Regulatory T Cells (CD8/Treg)
Secondary outcome measures
Change in Percentage of Inducible T-cell Co-stimulator (ICOS) + CD4 T Cells.
Change in Tumor Expression Programmed Death-ligand 1 (PD-L1).
Median Overall Survival (OS)
+7 moreSide effects data
From 2023 Phase 3 trial • 713 Patients • NCT0212546136%
Cough
24%
Fatigue
22%
Dyspnoea
18%
Diarrhoea
17%
Arthralgia
17%
Radiation pneumonitis
15%
Pyrexia
15%
Decreased appetite
14%
Nausea
13%
Pruritus
13%
Rash
12%
Upper respiratory tract infection
12%
Constipation
11%
Asthenia
11%
Hypothyroidism
11%
Headache
11%
Back pain
10%
Productive cough
10%
Pneumonia
9%
Pneumonitis
9%
Nasopharyngitis
9%
Insomnia
8%
Musculoskeletal pain
8%
Vomiting
8%
Oedema peripheral
8%
Myalgia
8%
Dry skin
7%
Hyperthyroidism
7%
Anaemia
7%
Bronchitis
7%
Dizziness
7%
Non-cardiac chest pain
7%
Pain in extremity
6%
Urinary tract infection
5%
Hypertension
5%
Hypokalaemia
5%
Paraesthesia
5%
Musculoskeletal chest pain
1%
Lung infection
1%
Atrial fibrillation
1%
Myocardial infarction
1%
Cardiac failure congestive
1%
Sepsis
1%
Herpes zoster
1%
Chronic obstructive pulmonary disease
1%
Acute kidney injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab (MEDI4736)
Placebo
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: MEDI4736Experimental Treatment1 Intervention
8 patients will receive an infusion of MEDI4736 (15 mg/kg intravenously, once), one to six weeks prior to surgical resection.
Group II: MEDI4736 + TremelimumabActive Control2 Interventions
8 patients will receive an infusion of MEDI4736 (1500 mg intravenously, once) + tremelimumab (75mg intravenously, once), one to six weeks prior to surgical resection.
Group III: Untreated arm (control)Placebo Group1 Intervention
4 patients will not receive MEDI4736 or Tremelimumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEDI4736
2016
Completed Phase 3
~5560
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,000 Previous Clinical Trials
6,001,906 Total Patients Enrolled
3 Trials studying Mesothelioma
71 Patients Enrolled for Mesothelioma
Bryan Burt, MDPrincipal InvestigatorBaylor College of Medicine
2 Previous Clinical Trials
59 Total Patients Enrolled
1 Trials studying Mesothelioma
12 Patients Enrolled for Mesothelioma
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