Last reviewed · How we verify
Phase II MEDI4736 in Combination With Chemotherapy for First-Line Treatment of Unresectable Mesothelioma
Phase 2 trial testing Durvalumab in Mesothelioma in 55 participants. Completed in 29 June 2023.
| Lead sponsor | PrECOG, LLC. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 13 June 2017 |
| Primary completion | 16 February 2020 |
| Estimated completion | 29 June 2023 |
| Sites | 20 locations across United States |
PrECOG, LLC. — full company profile →
18 and older, any sex, with Mesothelioma or Pleural Mesothelioma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall survival (OS) is defined as the time from randomization to death from any cause. Patients that have not had an event reported at analysis will be censored at their date of last follow-up.
| Group | Value | 95% CI |
|---|---|---|
| Concurrent Durvalumab Then Maintenance Durvalumab | 20.4 | 13.0 – 28.5 |
Number of participants with abnormal laboratory values and/or adverse events related to treatment.
| Group | Value | 95% CI |
|---|---|---|
| Concurrent Durvalumab Then Maintenance Durvalumab | 36 |
Progression-free survival (PFS) is defined as the time from randomization to documented disease progression or death from any cause, whichever occurs first. Patients who have not experienced an event of interest by the time of analysis will be censored at the date they are last known to be alive and progression-free.
| Group | Value | 95% CI |
|---|---|---|
| Concurrent Durvalumab Then Maintenance Durvalumab | 6.7 | 6.1 – 8.4 |
TTP measured from the time concurrent treatment with chemotherapy/durvalumab begins until radiologic or clinical progression is noted.
| Group | Value | 95% CI |
|---|---|---|
| Concurrent Durvalumab Then Maintenance Durvalumab | 6.8 | 6.2 – 8.4 |
ORR assessed in accordance with RECIST 1.1 (modified for malignant mesothelioma).
| Group | Value | 95% CI |
|---|---|---|
| Concurrent Durvalumab Then Maintenance Durvalumab | 31 |
Time frame: Adverse Events monitored for up to 15 months from start of treatment; deaths monitored from randomization for up to 32 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Concurrent Durvalumab Then… |
|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Fatigue | General disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| White blood cell count decreased | Investigations | — |
| Hypertension | Vascular disorders | — |
| Lymphopenia | Blood and lymphatic system disorders | — |
| Pneumonia | Infections and infestations | — |
| Syncope | Nervous system disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Embolism | Vascular disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Pericardial effusion | Cardiac disorders | — |
| Deafness | Ear and labyrinth disorders | — |
| Stomatitis | Gastrointestinal disorders | — |
| Cellulitis | Infections and infestations | — |
| Peritonitis | Infections and infestations | — |
| Sepsis | Infections and infestations | — |
| Alanine aminotransferase increased | Investigations | — |
| Amylase increased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Blood alkaline phosphatase increased | Investigations | — |
| Blood creatinine increased | Investigations | — |
| Platelet count decreased | Investigations | — |
| Reaction | System | Concurrent Durvalumab Then… |
|---|---|---|
| Fatigue | General disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| cough | Respiratory, thoracic and mediastinal disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Oedema peripheral | General disorders | — |
| Weight decreased | Investigations | — |
| Hypothyroidism | Endocrine disorders | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Dizziness | Nervous system disorders | — |
| Insomnia | Psychiatric disorders | — |
| Dry eye | Eye disorders | — |
| Pyrexia | General disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — |
| Headache | Nervous system disorders | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — |
| Hypokalaemia | Metabolism and nutrition disorders | — |
| Neuropathy peripheral | Nervous system disorders | — |
| Depression | Psychiatric disorders | — |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — |
| Lacrimation increased | Eye disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Contusion | Injury, poisoning and procedural complications | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — |
Most-reported serious reactions: Anaemia, Hyponatraemia, Fatigue, Thrombocytopenia, White blood cell count decreased, Hypertension, Lymphopenia, Pneumonia.
Data from ClinicalTrials.gov NCT02899195 adverse events section.
Patients with pleural mesothelioma that can not be surgically removed will receive durvalumab, in combination with standard chemotherapy of pemetrexed and cisplatin as first-line treatment. Durvalumab is a type of drug called a monoclonal antibody (a type of protein). Laboratory tests show that it works by allowing the immune system to detect your cancer and reactivates the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see whether adding durvalumab to standard chemotherapy will improve overall survival (OS).
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02899195.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing