A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: Bristol-Myers Squibb
• Treatments: Carboplatin; Cisplatin; Nivolumab; Pemetrexed

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

• 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