Evaluation of 2nd or 3rd line treatment by Nivolumab monotherapy or Nivolumab plus Ipilimumab, for unresectable Mesothelioma patients

Phase 1

• Conditions: Malignant Pleural Mesothelioma; MedDRA version: 18.1Level: LLTClassification code 10035605Term: Pleural mesothelioma malignant advancedSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004475-75-FR
• Lead Sponsor: IFCT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-14
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 114

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
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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified