A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma

Phase 1

Active, not recruiting

• Conditions: Malignant Pleural Mesothelioma
• Interventions: Drug: Nivolumab; Drug: Pemetrexed; Drug: Cisplatin or Carboplatin

• Registration Number: NCT04162015
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-12
• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-12
• Study First Posted: 2019-11-13
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nivolumab with pemetrexed and cisplatin or carboplatin	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.
nivolumab with pemetrexed and cisplatin or carboplatin	Nivolumab	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.
nivolumab with pemetrexed and cisplatin or carboplatin	Pemetrexed	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (7)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau; 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Bergen; 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States

Memoiral Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States