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 co-stimulation 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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