A Study to Evaluate the Efficacy and Safety of Multiple Immunotherapy-Based Treatments Combinations in Patients with Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
- Conditions
- Pancreatic ductal adenocarcinomaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004126-42-ES
- Lead Sponsor
- F. Hoffman-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 185
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed metastatic PDAC
- Disease progression during or within 6 months after treatment with one line of 5-fluorouracil or gemcitabine-based chemotherapy in the metastatic setting
- 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 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 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120
- 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
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 (objective response) of immunotherapy-based treatment combinations<br>•To evaluate the safety of immunotherapy-based treatment combinations;Primary end point(s): 1.Objective response<br>2.Incidence, nature, and severity of adverse events and laboratory abnormalities <br>3.Change from baseline in vital signs and ECG parameters<br>4.Change from baseline in targeted clinical laboratory test results;Timepoint(s) of evaluation of this end point: 1-4. As defined in the study protocol;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<br>•To characterize the pharmacokinetic profile of drugs that are administered as part of an immunotherapy-based treatment combination<br>•To evaluate the immune response (immunogenicity) to drugs that are administered as part of an immunotherapy-based treatment combination
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1.Progression free survival<br>2.Overall survival<br>3.Overall survival at specific timepoints<br>4.Duration of response<br>5.Disease control<br>6.Plasma or serum concentration of each drug (as appropriate) at specified timepoints<br>7.For drugs for which anti-drug antibody (ADA) formation is measured: presence of ADAs during the study relative to the presence of ADAs at baseline;Timepoint(s) of evaluation of this end point: 1-7. As defined in the study protocol