Malignant Pleural Mesothelioma MedDRA version: 18.1 Level: LLT Classification code 10035605 Term: Pleural mesothelioma malignant advanced System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Opdivo
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: Nivolumab
Other descriptive name: NIVOLUMAB
Concentration unit: mg/kg milligram(s)/kilogr
Sponsors
IFCT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proved diagnosis of unresectable malignant pleural Mesothelioma (MPM) 2. Available (archival and/or fresh) pathological samples for centralized PD-L1 expression assessment by immunohistochemistry 3. Age = 18 years old; male and female 4. ECOG Performance status 0-1 5. Weight loss 12 weeks 7. Documented progression of the MPM, assessed by computed tomography (CT) –Scan. 8. Measurable disease, defined as at least 1 lesion (measurable) that can be accurately assessed at baseline by CT-Scan and is suitable for repeated assessment using modified Response Evaluation Criteria in Solid Tumors [RECIST] for pleural mesothelioma (Byrne 2004; Therasse 2006). 9. Previous treatment by 1 or 2 systemic chemotherapy lines (1 line of chemotherapy considered if the patient received =2 cycles of this chemotherapy), including at least one line with pemetrexed in combination with platinum agent (i.e. “gold standard chemotherapy in MPM; triplet including bevacizumab also accepted) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 68 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46
Exclusion criteria
Exclusion criteria: 1. Patients with primitive peritoneal, pericardial, testis or tunica vaginalis mesothelioma 2. Patients with a recent history of other malignancies except adequately treated non-melanoma skin cancer, and curatively treated in-situ cancer. Ppatients with prostate adenocarcinoma diagnosed less than 5 years could be included in case of localized prostate cancer with good outcome according the Amico classification: = T2a and Gleason Score =6 and PSA blood level =10 ng/ml, and treated with curative intent (surgery or radiotherapy) without chemotherapy. Patients with history of solid tumors, including adenocarcinoma, treated with curative intent and without any evidence of disease >5 years can be included as well. 3. Brain metastasis, except if surgically resected or treated with stereotaxic radiotherapy with no evolution within the 3 months before inclusion, and asymptomatic patient 4. History of primary immunodeficiency, history of organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy. 5. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Intranasal/inhaled or topical steroids, and adrenal replacement steroid doses = 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We raise the hypothesis that inhibition of immune PD-1+/- CTLA-4 check-point(s) would delay tumor progression in patients with unresectable MPM, experiencing disease progression after one or two lines of chemotherapy including at least first-line with pemetrexed and platinum, without altering significantly the quality of life of patients. ;Secondary Objective: Toxicity, Progression-Free Survival, Overall Survival, Quality of Life, evaluation of PD-L1 immunohistochemistry score as a predictor of DCR, prognostic impact of biomarkers (exploratory studies).;Primary end point(s): Disease control rate;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Toxicity, Progression-Free Survival, Overall Survival, Quality of Life, evaluation of PD-L1 immunohistochemistry score as a predictor of DCR, prognostic impact of biomarkers (exploratory studies).;Timepoint(s) of evaluation of this end point: During all the study | — |
Countries
France
Contacts
Public ContactContact
IFCT
Outcome results
None listed