Description:
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.
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.
Recruiting
Phase 1
Drug | Synonyms | Arms |
---|---|---|
Nivolumab | nivolumab with pemetrexed and cisplatin or carboplatin | |
Pemetrexed | nivolumab with pemetrexed and cisplatin or carboplatin | |
Cisplatin or Carboplatin | nivolumab with pemetrexed and cisplatin or carboplatin |
Name | Type | Description | Interventions |
---|---|---|---|
nivolumab with pemetrexed and cisplatin or carboplatin | Experimental | Eligible patients will receive two cycles of neoadjuvant therapy with nivolumab 360 mg, pemetrexed 500 mg/m2, and cisplatin 75 mg/m2 or carboplatin AUC=5. Subsequently, they will undergo pleurectomy/decortication. |
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Inclusion Criteria: - Age ≥ 18 years - Karnofsky performance status > 70% - Pathologic diagnosis of malignant pleural mesothelioma. - At least one measurement must be >1.5 cm. - 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | number of patients going to operating room for surgical resection |
Time Frame: | 30 days of the initially planned date |
Safety Issue: | |
Description: | Patients who experience a greater than 30 day toxicity induced delay of surgery will be counted as a failure for the primary feasibility endpoint. |
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
July 27, 2021