A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus–Pancreatic Cancer)
- Conditions
- Pancreatic ductal adenocarcinoma (PDAC)MedDRA version: 21.0Level: LLTClassification code: 10033604Term: Pancreatic cancer Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-511271-15-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 282
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 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, 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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy 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, To evaluate the safety of immunotherapy-based treatment combinations;Primary end point(s): 1. Objective response
- Secondary Outcome Measures
Name Time Method Secondary end point(s):1. Progression free survival;Secondary end point(s):2. Overall survival;Secondary end point(s):3. Overall survival at specific timepoints;Secondary end point(s):4. Duration of response;Secondary end point(s):5. Disease control;Secondary end point(s):6. Incidence, nature, and severity of adverse events and laboratory abnormalities;Secondary end point(s):7. Change from baseline in vital signs and ECG parameters;Secondary end point(s):8. Change from baseline in targeted clinical laboratory test results