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A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma

Primary Purpose

Malignant Pleural Mesothelioma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nivolumab
Pemetrexed
Cisplatin or Carboplatin
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Mesothelioma focused on measuring Nivolumab, Surgery, Pemetrexed, Cisplatin, Carboplatin, 19-272

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Memoiral Sloan Kettering Basking RidgeRecruiting
  • Memorial Sloan Kettering MonmouthRecruiting
  • Memorial Sloan Kettering BergenRecruiting
  • Memorial Sloan Kettering CommackRecruiting
  • Memorial Sloan Kettering WestchesterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Memorial Sloan Kettering NassauRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nivolumab with pemetrexed and cisplatin or carboplatin

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 12, 2019
Last Updated
July 27, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04162015
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Mesothelioma
Keywords
Nivolumab, Surgery, Pemetrexed, Cisplatin, Carboplatin, 19-272

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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).
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nivolumab with pemetrexed and cisplatin or carboplatin
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
nivolumab 360 mg
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
500 mg/m^2
Intervention Type
Drug
Intervention Name(s)
Cisplatin or Carboplatin
Intervention Description
cisplatin 75 mg/m2 or carboplatin AUC=5
Primary Outcome Measure Information:
Title
number of patients going to operating room for surgical resection
Description
Patients who experience a greater than 30 day toxicity induced delay of surgery will be counted as a failure for the primary feasibility endpoint.
Time Frame
30 days of the initially planned date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Offin, MD
Phone
646-449-1778
Email
offinm@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Marjorie Zauderer, MD
Phone
646-608-3790
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Offin, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memoiral Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Offin, MD
Phone
646-449-1778
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Offin, MD
Phone
646-449-1778
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Offin, MD
Phone
646-449-1778
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Offin, MD
Phone
646-449-1778
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Offin, MD
Phone
646-449-1778
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Offin, MD
Phone
646-449-1778
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Offin, MD
Phone
646-449-1778

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma

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