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Pembrolizumab After Radiation Therapy in Treating Patients With Pleural Malignant Mesothelioma
Phase 1 trial testing Laboratory Biomarker Analysis in Pleural Malignant Mesothelioma in 24 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 May 2017 |
| Primary completion | 15 November 2024 |
| Estimated completion | 31 December 2028 |
| Sites | 1 location across United States |
M.D. Anderson Cancer Center — full company profile →
18 and older, any sex, with Pleural Malignant Mesothelioma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To determine the safety and tolerability of pembrolizumab administered after radiation therapy in patients with MPM. The primary endpoint was "unaccepable" high grade adverse events (AEs) from baseline to 4-month after the start of radiation therapy.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 0 | |
| Cohort 2 | 0 |
To assess overall survival (OS) in patients receiving Pembrolizumab after radiation therapy for MPM.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 12.2 | 7.7 – 23.6 |
| Cohort 2 | 16.3 | 6.3 – 22.2 |
To assess progression-free survial (PFS) in patients receiving Pembrolizumab after radiation therapy for MPM.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 7.7 | 4.2 – 19.8 |
| Cohort 2 | 4 | 3.3 – 11.4 |
Time frame: Baseline to 4-months after radiation therapy up to 5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cohort 1 | Cohort 2 |
|---|---|---|---|
| Lung infection | Infections and infestations | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Death NOS | General disorders | — | — |
| Dysphagia | General disorders | — | — |
| Pain | General disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Esophagitis | General disorders | — | — |
| Gastritis | General disorders | — | — |
| Infections and infestations - Other | Infections and infestations | — | — |
| Creatinine increased | Investigations | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Acute Kidney injury | Renal and urinary disorders | — | — |
| Urinary retention | Renal and urinary disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Tracheal mucositis | Respiratory, thoracic and mediastinal disorders | — | — |
| Thromboembolic event | Vascular disorders | — | — |
| Reaction | System | Cohort 1 | Cohort 2 |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Dysphagia | Gastrointestinal disorders | — | — |
| Pain | General disorders | — | — |
| Esophagitis | Gastrointestinal disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Blood and lymphatic system disorders-Other, specify | Blood and lymphatic system disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Creatinine increased | Investigations | — | — |
| Weight loss | Investigations | — | — |
| Aspartate aminotransferase increased | Gastrointestinal disorders | — | — |
| Aspartate aminotansferase increased | Investigations | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Depression | Psychiatric disorders | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Rash acneiform | Skin and subcutaneous tissue disorders | — | — |
| Hypothyroidism | Endocrine disorders | — | — |
| Alanine aminotransferase increased | Gastrointestinal disorders | — | — |
| Non-cardiac chest pain | General disorders | — | — |
| Lung infection | Respiratory, thoracic and mediastinal disorders | — | — |
| Alkaline phosphatase increased | Investigations | — | — |
| Alanine aminotansferase increased | Investigations | — | — |
| Hyperuricemia | Metabolism and nutrition disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Chest wall pain | Musculoskeletal and connective tissue disorders | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — |
| Paresthesia | Nervous system disorders | — | — |
| Presyncope | Nervous system disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Edema Limbs | Blood and lymphatic system disorders | — | — |
Most-reported serious reactions: Lung infection, Pneumonitis, Respiratory failure, Death NOS, Dysphagia, Pain, Constipation, Esophagitis.
Data from ClinicalTrials.gov NCT02959463 adverse events section.
This phase I trial studies the side effects and best way to give pembrolizumab after radiation therapy in treating patients with pleural malignant mesothelioma. Radiation therapy uses high energy radiation to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab after radiation therapy may kill more tumor cells.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing