Nivolumab Monotherapy or Nivolumab Plus Ipilimumab, for Unresectable Malignant Pleural Mesothelio… (NCT02716272) | Clinical Trial Compass
CompletedPhase 2
Nivolumab Monotherapy or Nivolumab Plus Ipilimumab, for Unresectable Malignant Pleural Mesothelioma (MPM) Patients
France125 participantsStarted 2016-03-24
Plain-language summary
The sponsor 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically proved diagnosis of unresectable malignant pleural Mesothelioma (MPM)
✓. Available (archival and/or fresh) pathological samples for centralized PD-L1 expression assessment by immunohistochemistry
✓. Age ≥ 18 years old; male and female
✓. ECOG Performance status 0-1
✓. Weight loss \< 10% during last 3 months
✓. Life expectancy \> 12 weeks
✓. Documented progression of the MPM, assessed by computed tomography (CT) -Scan.
✓. 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).
Exclusion criteria
✕. Patients with primitive peritoneal, pericardial, testis or tunica vaginalis mesothelioma
✕. Patients with a recent history of other malignancies except adequately treated non-melanoma skin cancer, and curatively treated in-situ cancer. Patients 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.
What they're measuring
1
Disease Control rate assessed by CT scan
Timeframe: 3-months
Trial details
NCT IDNCT02716272
SponsorIntergroupe Francophone de Cancerologie Thoracique
✕. Brain metastasis, except if surgically resected or treated with stereotaxic radiotherapy with no evolution within the 3 months before inclusion, and asymptomatic patient
✕. 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.
✕. 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.
✕. Live attenuated vaccination administered within 30 days prior to randomization.
✕. Known history of interstitial lung disease (asbestosis…) or CT-scan signs of interstitial lung disease.
✕. Subjects with an active, known or suspected autoimmune disease, including systemic lupus erythematosis or Wegener's granulomatosis. Subjects with type I diabetes mellitis, or hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, are permitted to enroll.