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The objective of this study is to evaluate the safety, tolerability, and antitumor
activity of oleclumab (MEDI9447) in combination with or without durvalumab plus
chemotherapy in participants with metastatic pancreatic cancer.
Inclusion Criteria
Age >= 18
Written and signed informed consent must be obtained
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Weight >= 35 kg
Participants must have histologically or cytologically, confirmed pancreatic adenocarcinoma: Cohort A: Participants with previously untreated metastatic pancreatic adenocarcinoma (1L metastatic disease) not previously treated with systemic therapies Cohort B: Participants with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, oxaliplatin) 2L metastatic disease
Participants must have at least 1 measurable lesion according to RECIST v1.1
All Participants must consent to providing archival tumor specimens.
Exclusion Criteria
Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment.
Prior receipt of any immune-related therapy
Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed.
Participants with a history of venous thrombosis within the past 3 months
Participants with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 3 months prior to start of treatment
Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
Other invasive malignancy within 2 years
Any history of leptomeningeal disease or cord compression
Current or prior use of immunosuppressive medication within 14 days prior to the first dose.
Additional locations may be listed on ClinicalTrials.gov for NCT03611556.
Locations matching your search criteria
United States
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Temporarily closed to accrual
Name Not Available
North Carolina
Durham
Duke University Medical Center
Status: Active
Name Not Available
This is a Phase 1b/2, multicenter, open-label, dose-escalation, and dose-expansion study
to assess the safety, preliminary antitumor activity, immunogenicity, and
pharmacokinetics (PK) of oleclumab with or without durvalumab in combination with
chemotherapy administered in participants with metastatic pancreatic ductal
adenocarcinoma (PDAC). Participants with previously untreated metastatic PDAC (first-line
[1L] metastatic PDAC) will be enrolled in Cohort A. Participants with metastatic PDAC
previously treated with gemcitabine-based chemotherapy (without exposure to
5-fluorouracil [5-FU], capecitabine, or oxaliplatin; second-line [2L] metastatic PDAC)
will be enrolled in Cohort B. The study consists of 2 parts, dose escalation (Part 1) and
