A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
Status: | Recruiting |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/30/2019 |
Start Date: | July 5, 2017 |
End Date: | September 19, 2020 |
Contact: | Reference Study ID Number: WO39608 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global-roche-genentech-trials@gene.com |
Phone: | 888-662-6728 (U.S. and Canada) |
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
A Phase Ib/II, open-label, multicenter, randomized study designed to assess the safety,
tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based
treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma
(PDAC).
Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of patients who
have received no prior systemic therapy for metastatic PDAC, and Cohort 2 will consist of
patients who have received one line of prior systemic therapy for PDAC. In each cohort,
eligible patients will be assigned to one of several treatment arms.
tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based
treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma
(PDAC).
Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of patients who
have received no prior systemic therapy for metastatic PDAC, and Cohort 2 will consist of
patients who have received one line of prior systemic therapy for PDAC. In each cohort,
eligible patients will be assigned to one of several treatment arms.
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma
- For patients in Cohort 1: no prior systemic treatment for PDAC
- For patients in Cohort 2: disease progression during administration of either 5-FU− or
gemcitabine-based first-line chemotherapy
- Life expectancy greater than or equal to 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 RECIST v1.1
- 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, and agreement to refrain from
donating eggs, 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
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 (CT) scan
- Positive human immunodeficiency (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
We found this trial at
17
sites
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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