A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 1

Conditions: Malignant Pleural Mesothelioma

Treatments: Drug: Cisplatin or Carboplatin; Drug: Pemetrexed; Drug: Nivolumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04162015

19-272

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

nivolumab with pemetrexed and cisplatin or carboplatin

Experimental group

Description:

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.

Treatment:

Drug: Nivolumab

Drug: Pemetrexed

Drug: Cisplatin or Carboplatin