A randomized phase II study evaluating efficacy and safety of 2nd or 3rd line treatment by Nivolumab monotherapy or Nivolumab plus Ipilimumab, for unresectable Malignant Pleural Mesothelioma (MPM) patients - MAPS2

IFCT0 sites114 target enrollmentMarch 14, 2016

DrugsOpdivo Yervoy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: IFCT
Enrollment: 114
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 14, 2016

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

IFCT

Eligibility 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 \< 10% during last 3 months
•6\.Life expectancy \> 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

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.