Clinical Trials /

A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma

NCT04162015

Description:

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.

Related Conditions:
  • Malignant Pleural Mesothelioma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: 19-272
  • NCT ID: NCT04162015

Conditions

  • Malignant Pleural Mesothelioma

Interventions

DrugSynonymsArms
Nivolumabnivolumab with pemetrexed and cisplatin or carboplatin
Pemetrexednivolumab with pemetrexed and cisplatin or carboplatin
Cisplatin or Carboplatinnivolumab with pemetrexed and cisplatin or carboplatin

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
nivolumab with pemetrexed and cisplatin or carboplatinExperimentalEligible 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
  • Pemetrexed
  • Cisplatin or Carboplatin

Eligibility 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 analyses within 60 days prior to
             starting treatment as long as there was no interval cancer-directed therapy. If
             sufficient archival or fresh tissue is not available, then a repeat biopsy at baseline
             prior to starting study treatment will be required.

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:number of patients going to operating room for surgical resection
Time Frame:30 days of the initially planned date
Safety Issue:
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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Nivolumab
  • Surgery
  • Pemetrexed
  • Cisplatin
  • Carboplatin
  • 19-272

Last Updated

November 12, 2019