Clinical trial NCT04162015: A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma
Official title: Feasibility and Safety of Neoadjuvant Nivolumab and Chemotherapy for Resectable Malignant Pleural Mesothelioma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Malignant Pleural Mesothelioma
Keywords: Nivolumab
Surgery
Pemetrexed
Cisplatin
Carboplatin
19-272
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2019-11-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single institution pilot study of nivolumab with pemetrexed and cisplatin or carboplatin prior to surgery for patients with potentially resectable malignant pleural mesothelioma (MPM).
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: number of patients going to operating room for surgical resection
timeFrame: 30 days of the initially planned date
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memoiral Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michael Offin, MD
role: PRINCIPAL_INVESTIGATOR
References: