MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.

Completed · Phase 1/Phase 2

Conditions studied: Carcinoma, Metastatic Pancreatic Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT03611556

Run by

MedImmune LLC

People needed

213

Starts

2018-06-21

Expected to finish

2022-07-22

Last updated by the study team

2023-10-03

Who can join

Age: 18 and older, up to 101. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — La Jolla, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Fort Myers, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Buffalo, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Dallas, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Charlottesville, Virginia, United States
• Research Site — Seattle, Washington, United States
• Research Site — Madison, Wisconsin, United States
• Research Site — Blacktown, Australia
• Research Site — Clayton, Australia
• Research Site — Heidelberg, Australia
• Research Site — St Leonards, Australia
• Research Site — Oslo, Norway
• Research Site — Barcelona, Spain
• Research Site — Fuenlabrada, Spain

Full record on ClinicalTrials.gov

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