A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma

Malignant Pleural Mesothelioma Clinical Trial

Official title:

Feasibility and Safety of Neoadjuvant Nivolumab and Chemotherapy for Resectable Malignant Pleural Mesothelioma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04162015
• Other study ID #: 19-272
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 12, 2019
• Est. completion date: November 2025

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Pleural Mesothelioma
• Mesothelioma
• Mesothelioma, Malignant

Intervention

Drug:
• Nivolumab
nivolumab 360 mg
• Pemetrexed
500 mg/m^2
• Cisplatin or Carboplatin
cisplatin 75 mg/m2 or carboplatin AUC=5

Locations

Country	Name	City	State
United States	Memoiral Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients going to operating room for surgical resection	Patients who experience a greater than 30 day toxicity induced delay of surgery will be counted as a failure for the primary feasibility endpoint.	30 days of the initially planned date

External Links

•   Memorial Sloan Kettering Cancer Center