Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nivolumab in Patients With Recurrent Malignant Mesothelioma (NivoMes)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02497508
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : September 14, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Tracking Information
First Submitted Date  ICMJE July 6, 2015
First Posted Date  ICMJE July 14, 2015
Last Update Posted Date September 14, 2017
Study Start Date  ICMJE July 2015
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
DCR [ Time Frame: at 12 weeks ]
The number of patients that have CR or PR plus the number of patients that have SD, as a percentage of the total number of patients in the study.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
  • PFS [ Time Frame: Until progression, every 6 weeks up to 24 weeks. ]
    The time from the date of start of treatment to the date of the first documented tumor progression as determined by modified RECIST, or death due to any cause.
  • OS [ Time Frame: every 8 weeks until death ]
    The time from date of start of treatment to the date of death
  • TTP [ Time Frame: Until progression, every 6 weeks up to 24 weeks. ]
    The time from the date of start of treatment to the time of disease progression.
  • ORR [ Time Frame: Every 6 weeks up to 24 weeks. ]
    The number of subjects whose best confirmed objective response is a CR or PR, divided by the number of treated subjects.
  • Safety and tolerability (The incidence of (serious) adverse events) [ Time Frame: Participants will be followed fot the duration of the trial, an expected average of 6 weeks ]
    The incidence of (serious) adverse events
  • DCR [ Time Frame: At 6 months ]
    The number of patients that have CR or PR plus the number of patients that have SD, as a percentage of the total number of patients in the study.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 13, 2015)
Exploratory [ Time Frame: At screening and after cycle 3 (day 35-50) ]
The effects of nivolumab on tissue samples with respect to influx of immuno-modulating cells and the PD-L1 status of tumors and other possible biomarkers and explore correlations between biomarkers and anti-tumor activity.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Nivolumab in Patients With Recurrent Malignant Mesothelioma
Official Title  ICMJE A Single Arm Phase II Study of Nivolumab in Patients With Recurrent Malignant Pleural Mesothelioma: Interim Biopsy Analysis to Determine Efficacy. Acronym: NivoMes Study
Brief Summary

This is a prospective, single arm, phase II trial in previously treated patients with MPM who are considered candidates for immunotherapy and repeat thoracoscopies/transthoracic biopsies. Nivolumab will be administered 3 mg/kg q2 weeks by intravenous injection.

The administration of nivolumab as monotherapy will improve DCR form 20% to 40% at 12 weeks when compared to DCR of patients treated with best supportive care based on historical controls.

Detailed Description Patients will undergo pre- and post-treatment thoracoscopies/biopsies.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Pleural Mesothelioma
Intervention  ICMJE Drug: nivolumab
Other Name: BMS-936558
Study Arms  ICMJE Experimental: Nivolumab
Nivolumab will be administered 2 weekly by intravenous infusion in a dose of 3 mg/kg
Intervention: Drug: nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2015)
33
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with histological or cytological diagnosed malignant pleural mesothelioma and age >18 years.
  • Progressive disease after at least one course of chemotherapy.
  • Previous chemotherapy or experimental therapy ≥ 4 weeks ago.
  • Medically suitable for limited surgical intervention (pleural biopsies up to limited pleurectomy).
  • Not considered candidates for trimodality treatment (as part of a study).
  • Measurable or evaluable disease (see tumor response assessment).
  • Ability to understand the study and give signed informed consent prior to beginning of protocol specific procedures including the approval of a second thoracoscopy or transthoracic pleural biopsy after the third course.
  • Radiotherapy is allowed when this is given for palliation, the interval is > 12 weeks and not all tumor is within the irradiation field.
  • WHO performance status 0 or 1 (see appendix 1).
  • Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:

    • Hematology: Neutrophil count >= 1.5 x 109/l, Platelets >= 150 x 109/l, Hemoglobin >= 6,0 mmol/l.
    • Chemistry: Total serum bilirubin ≤ 1.5 times within the upper limits of normal (ULN); ASAT and ALAT <= 2.5x ULN, AP (alkaline phosphatases) < 5x ULN (unless bone metastases are present in the absence of any liver disease).

Age and Reproductive Status

  • Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception to avoid pregnancy during treatment and for 23 weeks after the last dose of investigational drug.
  • Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the first dose of nivolumab.
  • Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year during treatment and for a period of 31 weeks after the last dose of investigational drug.
  • Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception.

Exclusion Criteria:

  • Active uncontrolled infection, severe cardiac dysfunction or uncorrectable bleeding tendency.
  • Inability to perform biopsies of the pleural lesions.
  • Symptomatic peripheral neuropathy >= grade 2 according to NCI CTC, version 4.0.
  • Presence of symptomatic CNS metastases.
  • Unstable peptic ulcer, unstable diabetes mellitus or other serious disabling condition.
  • Impaired renal function: creatinine clearance less than 50ml/min.
  • Concomitant administration to any other experimental drugs under investigation.
  • Patients are excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
  • Patients are excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immuno-suppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Patients are excluded if they have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02497508
Other Study ID Numbers  ICMJE N14MPN
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Netherlands Cancer Institute
Study Sponsor  ICMJE The Netherlands Cancer Institute
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Paul Baas, MD, PhD The Netherlands Cancer Institute
Principal Investigator: Josine Quispel-Janssen, MD The Netherlands Cancer Institute
PRS Account The Netherlands Cancer Institute
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP