Malignant Pleural Mesothelioma
Conditions
Keywords
Nivolumab, Surgery, Pemetrexed, Cisplatin, Carboplatin, 19-272
Brief summary
This study will test whether giving nivolumab in combination with pemetrexed and either cisplatin or carboplatin before surgery is a safe and effective approach to treating resectable mesothelioma without delaying surgery.
Interventions
DRUGNivolumab
nivolumab 360 mg
DRUGPemetrexed
500 mg/m\^2
cisplatin 75 mg/m2 or carboplatin AUC=5
Sponsors
Bristol-Myers Squibb
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single institution pilot study of nivolumab with pemetrexed and cisplatin or carboplatin prior to surgery for patients with potentially resectable malignant pleural mesothelioma (MPM).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Karnofsky performance status \> 70% * Pathologic diagnosis of malignant pleural mesothelioma. * Potentially resectable by pleurectomy/decortication, as assessed by thoracic surgeon * Negative serum pregnancy test in women of childbearing potential * Female patients of childbearing potential must agree to use a highly effective form of contraception for the duration of the study and for at least 5 months after the last administration of nivolumab and at least 6 months after last administration of pemetrexed, whichever is longer * Male patients with female partners of childbearing potential must agree to use a highly effective form of contraception for the duration of the study and for at least 7 months after the last administration of nivolumab and at least 3 months after the last administration of pemetrexed, whichever is longer * Adequate archival or fresh tissue for correlative analysis. Archival tissue will be deemed acceptable as long as their was no interval therapy prior to cycle 1 day 1 of protocol therapy. If sufficient archival or fresh tissue is not available, then a repeat biopsy at baseline prior to starting study treatment will be required as long as medically safe and feasible * Absolute neutrophil count ≥ 1000/mcL * Total bilirubin ≤ 1.5 mg/dl * AST and ALT ≤ 3.0 x upper limit of normal * Creatinine ≤ 1.5 x upper limit of normal * Negative HIV serology blood test
Exclusion criteria
* Prior treatment with chemotherapy or immunotherapy for mesothelioma * Autoimmune disease requiring systemic immune modulating treatment during the past two years * Pregnant or lactating women * Known active hepatitis B or hepatitis C * Current use of systemic prednisone at dose ≥ 10 mg daily (or the equivalent dose with another corticosteroid) * Serious concurrent medical illness or another active cancer requiring treatment * Active pneumonitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients going to operating room for surgical resection | 30 days of the initially planned date | Patients who experience a greater than 30 day toxicity induced delay of surgery will be counted as a failure for the primary feasibility endpoint. |
Countries
United States
Outcome results
None listed