Pancreatic ductal adenocarcinoma
Conditions
Sponsors
F. Hoffman-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >= 18 years - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Histologically or cytologically confirmed metastatic PDAC - For patients in Cohort 1: no prior systemic treatment for PDAC - For patients in Cohort 2: disease progression during administration of either of 5-fluorouracil or gemcitabine-based first-line chemotherapy in the metastatic or locally advanced setting and, for patients treated in the locally advanced setting, occurrence of metastasis within 6 months after initiation of chemotherapy - Life expectancy >=3 months - Availability of a representative tumor specimen that is suitable for determination of programmed death ligand 1 (PD-L1) and/or additional biomarker status via central testing - Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 - Adequate hematologic and end-organ function test results - Tumor accessible for biopsy - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive, and agreement to refrain from donating eggs, measures as outlined for each specific treatment arm - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm 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 165 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 305
Exclusion criteria
Exclusion criteria: - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. - History of leptomeningeal disease - Active or history of autoimmune disease or immune deficiency - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan - Positive HIV test at screening or at any time prior to screening - Active hepatitis B or C virus infection or active tuberculosis - Severe infection within 4 weeks prior to initiation of study treatment - Prior allogeneic stem cell or solid organ transplantation - History of malignancy other than pancreatic carcinoma within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the efficacy (objective response) of immunotherapy-based treatment combinations •To evaluate the safety of immunotherapy-based treatment combinations ;Secondary Objective: •To evaluate the efficacy (progression free survival, overall survival, overall survival at specific timepoints, duration of response, and disease control) of immunotherapy-based treatment combinations ;Primary end point(s): 1.Objective response 2.Incidence, nature, and severity of adverse events and laboratory abnormalities 3.Change from baseline in vital signs and ECG parameters 4.Change from baseline in targeted clinical laboratory test results ;Timepoint(s) of evaluation of this end point: 1-4. Up to approximately 3-5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Progression free survival 2. Overall survival 3. Overall survival at specific timepoints 4. Duration of response 5. Disease control ;Timepoint(s) of evaluation of this end point: 1-2, 4-5 up to approximately 3-5 years 3. Month 6 | — |
Countries
Germany, Korea, Republic of, Spain, United States
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd
Outcome results
None listed