Malignant Pleural Mesothelioma MedDRA version: 20.0 Level: PT Classification code 10059518 Term: Pleural mesothelioma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Opdivo
Product Name: Nivolumab
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Institut für Klinische Krebsforschung IKF GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fully-informed written consent 2. Males and females = 18 years of age 3. Histologically proven initial diagnosis of malignant pleural mesothelioma of epithelioid subtype (patients can also be included if biphasic histologic subtype has been identified during surgery) 4. Postoperative stage I-III (TNM 8th Edition; pT1-pT4, pN0-pN2, cM0). Patients are only included with a completeness of cytoreduction score (CC score) =65 years) yes F.1.3.1 Number of subjects for this age range 62
Exclusion criteria
Exclusion criteria: 1. Metastatic disease. 2. Patients for which surgery was scheduled as a cytoreductive surgery with curative intent but was then defined as palliative P/D by the operating surgeon. 3. Previous drug therapy against MPM. 4. A continuous post-operative hospitalization > 6 weeks due to surgery-related complications. 5. 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. 6. Inadequate hematological, renal and hepatic functions including the following: a. WBC 1.5 x ULN unless creatinine clearance = 45 mL/min (measured or calculated using the Cockroft-Gault formula). For application of cisplatin, creatinine clearance must be = 60 mL/min. (measured or calculated using the Cockroft-Gault formula). f. AST/ALT >3.0 x ULN g. Total bilirubin >1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent). 11. Any serious or uncontrolled medical disorder or active infection that, in the opinion of the Investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive study drug. 12. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or compliance with the study protocol. 13. Pregnant or breast-feeding women. 14. Positive testing for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. 15. Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV). 16. Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that the medical monitor be consulted prior to signing informed consent. 17. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this clinical trial is to determine if addition of nivolumab to adjuvant chemotherapy and subsequent administration of nivolumab mono-agent as maintenance therapy will improve TNT in stage I to stage III MPM patients that were previously subject to extended P/D ± HITOC. Primary Endpoint The primary efficacy endpoint is: • Time-to-next-treatment (TNT) The safety endpoints are Safety and tolerability.;Secondary Objective: The secondary endpoints will include: • Progression-free-survival (PFS) • Overall survival (OS) • Proportion of patients with Treatment Beyond Progressoin (TBP), duration of TBP in this population • Quality of life (QoL, based on LCSS-Meso and EQ-5D) Exploratory Endpoints • Biomarker exploration ;Primary end point(s): The primary efficacy endpoint is: • Time-to-next-treatment (TNT) The safety endpoints are Safety and tolerability ;Timepoint(s) of evaluation of this end point: After LPLV / at end of trial. Safety and tolerability will be monitored continously, final analysis will be done at the end of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression-free-survival (PFS) • Overall survival (OS) • Proportion of patients with Treatment Beyond Progressoin (TBP), duration of TBP in this population • Quality of life (QoL, based on LCSS-Meso and EQ-5D) • Biomarker exploration ;Timepoint(s) of evaluation of this end point: After LPLV / at end of trial | — |
Countries
Germany
Contacts
Public ContactIKF
Institut für Klinische Krebsforschung IKF GmbH
Outcome results
None listed