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A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04162015
Recruitment Status : Recruiting
First Posted : November 13, 2019
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Malignant Pleural Mesothelioma Drug: Nivolumab Drug: Pemetrexed Drug: Cisplatin or Carboplatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Safety of Neoadjuvant Nivolumab and Chemotherapy for Resectable Malignant Pleural Mesothelioma
Actual Study Start Date : November 12, 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022


Arm Intervention/treatment
Experimental: nivolumab with pemetrexed and 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.
Drug: Nivolumab
nivolumab 360 mg

Drug: Pemetrexed
500 mg/m^2

Drug: Cisplatin or Carboplatin
cisplatin 75 mg/m2 or carboplatin AUC=5




Primary Outcome Measures :
  1. number of patients going to operating room for surgical resection [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Karnofsky performance status > 70%
  • Pathologic diagnosis of malignant pleural mesothelioma.
  • At least one measurement must be >1.5 cm.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04162015


Contacts
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Contact: Michael Offin, MD 646-449-1778 offinm@mskcc.org
Contact: Marjorie Zauderer, MD 646-608-3790

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Michael Offin, MD    646-449-1778      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Michael Offin, MD    646-449-1778      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Michael Offin, MD    646-449-1778      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Michael Offin, MD    646-449-1778      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Michael Offin, MD    646-449-1778      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Michael Offin, MD    646-449-1778      
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Michael Offin, MD    646-449-1778      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Bristol-Myers Squibb
Investigators
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Principal Investigator: Michael Offin, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04162015    
Other Study ID Numbers: 19-272
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Nivolumab
Surgery
Pemetrexed
Cisplatin
Carboplatin
19-272
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Carboplatin
Nivolumab
Pemetrexed
Antineoplastic Agents
Antineoplastic Agents, Immunological
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors