Randomized Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 800

Inclusion Criteria

-) Male and female subjects (over 18 years of age)
-) Histologically proven diagnosis of MPM, thoracoscopy is highly
recommended.
-) Advanced unresectable disease that is not amenable to therapy with
curative intent (surgery with or without chemotherapy). Subjects that
refuse potentially curative surgery are ineligible
-) Available (archival and/or fresh) pathological samples for centralized
PD-L1 IHC testing during the screening period. Subjects cannot be
randomized until the tumor tissue for PD-L1 testing has been received at
the Central Lab, however, the result of the testing is not required prior to
randomization. Subjects can initiate therapy before the result of PD-L1
testing is available.
-) Prior palliative radiotherapy is acceptable, but at least 14 days must
have passed since the administration of the radiotherapy and all signs of
toxicity must have remitted.
- ECOG Performance Status of 0-1.
-) Measurable disease, defined as at least 1 lesion measured in up to two
positions at three separate levels on transverse cuts of CT scan that is
suitable for repeated assessment using adapted modified Response
Evaluation Criteria in Solid Tumors [m-RECIST] for pleural mesothelioma
-) Adequate hematological, renal and hepatic functions.
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 144
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 176

Exclusion Criteria

-) Primitive peritoneal, pericardial and tunica vaginalis testis
mesotheliomas
-) Brain metastasis, except if surgically resected or treated with
stereotaxic radiotherapy with no evolution within
the 3 months before inclusion, and asymptomatic. In addition, subjects
must be either off corticosteroids, or on a
stable or decreasing dose of less or equal to 10 mg daily prednisone (or
equivalent) for at least 2 weeks prior to randomization,
-) Prior treatment with adjuvant or neoadjuvant chemotherapy; radical
pleuropneumonectomy with or without
intensity modulated radiotherapy, or non-palliative RT
-) Prior intraoperative or intracavitary chemotherapy for pleural
mesothelioma
-) 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 costimulation
or checkpoint pathways.
-) History of chronic inflammatory or autoimmune disease
-) Concurrent or prior malignancy requiring or anticipated to require
concurrent intervention
-) Subjects with interstitial lung disease that is symptomatic or may
interfere with the detection or management of
suspected drug-related pulmonary toxicity.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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