Feasibility and Safety of Neoadjuvant Nivolumab and Chemotherapy for Resectable Malignant Pleural Mesothelioma
Overview
- Phase
- Phase 1
- Intervention
- Nivolumab
- Conditions
- Malignant Pleural Mesothelioma
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 22
- Locations
- 7
- Primary Endpoint
- number of patients going to operating room for surgical resection
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
nivolumab with pemetrexed and cisplatin or carboplatin
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.
Intervention: Nivolumab
nivolumab with pemetrexed and cisplatin or carboplatin
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.
Intervention: Pemetrexed
nivolumab with pemetrexed and cisplatin or carboplatin
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.
Intervention: Cisplatin or Carboplatin
Outcomes
Primary Outcomes
number of patients going to operating room for surgical resection
Time Frame: 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.