Metastatic germ cell tumors
Conditions
Sponsors
SGHL – SOCIEDADE GESTORA DO HOSPITAL DE LOURES, S.A - Hospital Beatriz Ângelo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: »» Male or female, aged 18 years. »» Metastatic GCT, seminoma or non-seminoma, previously treated with standard doublet or triplet cisplatin-containing chemotherapy for metastatic disease in: a. second or further relapse from primary testicular, retroperitoneal or ovarian GCT; b. first or further relapse of PMNSGCT; c. primary-refractory GCT (defined as progression within 8 weeks of finishing first-line chemotherapy for advanced GCT); or d. “late relapse” (> 2 years after cisplatinum-containing chemotherapy for metastatic GCT) that is not amenable to surgical resection. »» Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2. »» Evidence of recurrent disease by imaging (CT or MR) or rising tumor markers (aFP or HCG). NOTE: If a rising tumor marker is the only evidence of progressive disease, at least 2 consecutive rising values at least one week apart are needed and alternative causes of increased serum levels of these markers must be excluded (cross reaction with luteinizing hormone (LH) (that can be tested if needed by testosterone suppression of LH), liver disease, use of marijuana, or second primary tumor) »» Received initial cisplatin based combination therapy, such as BEP, EP, VIP, or similar regimens AND, for primary testicular or ovarian GCT, progression after at least one 'salvage' chemotherapy regimen (such as, TIP, VeIP, VIP or high dose chemotherapy with ASCT). 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 29 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: »» Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. »» History of allergy or hypersensitivity to study drug components. »» Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the patient to receive protocol therapy, or interfere with the interpretation of study results. »» Patients with an active, known or suspected autoimmune disease. »»»» Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical activity of nivolumab monotherapy, as measured by the investigator-assessed CBR, in patients with platinum-recurrent or platinum-refractory metastatic GCT. CBR is defined by sum of CRs, PRs and stable disease (SD) for at least 3 months, with stable or declining tumor markers (aFP and HCG), using Response Evaluation Criteria In Solid Tumors (RECIST 1.1);Secondary Objective: »»Determine CR plus marker-negative PR rate »»Evaluate overall survival rate (OS) »»Evaluate Progression Free Survival (PFS) »»Measure the duration of clinical response;Primary end point(s): clinical benefit rate (CBR);Timepoint(s) of evaluation of this end point: »»Serum tumor-specific markers every cycle: HCG, aFP and LDH »»Tumor Imaging Assessment: CT (every 10 weeks) and PET | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): »»Determine CR plus marker-negative PR rate »»Evaluate overall survival rate (OS) »»Evaluate Progression Free Survival (PFS) »»Measure the duration of clinical response;Timepoint(s) of evaluation of this end point: »»Serum tumor-specific markers every cycle: HCG, aFP and LDH »»Tumor Imaging Assessment: CT (every 10 weeks) and PET | — |
Countries
Portugal
Contacts
Public ContactRita Eça
SOCIEDADE GESTORA DO HOSPITAL DE LOURES, S.A - Hospital Beatriz Ângelo
Outcome results
None listed