Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18 - 101
Clinical summary
Summary
Participants in this trial will be randomised into one of 6 Arms of treatment, across two distinct cohorts. In cohort A, patients must have previously untreated metastatic pancreatic cancer (1st line metastatic disease). In Cohort B, patients with metastatic pancreatic cancer may have been previously treated with gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, oxaliplatin) 2nd line metastatic disease. Two Arms across Cohort A and B (Arm A1 and Arm B1) will act as a comparators to the trial treatment, in which participants will either receive gemcitabine and nab-paclitaxel or mFOLFOX chemotherapy. In Arm A2 participants will receive gemcitabine and nab-paclitaxel plus MEDI9447, and in Arm A3 participants will also receive durvalumab on top of the Arm A2 treatment. In Arm B2 participants will receive mFOLXFOX chemotherapy plus MEDI9447, and in Arm B3 participants will also receive durvalumab on top of the Arm B2 treatment. All treatment will be given until disease progression.
Conditions
This trial is treating people with pancreatic cancer
Eligibility
Inclusion
- 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
- 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
MedImmune, LLC
Scientific Title
A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) With or Without Durvalumab in Combination With Chemotherapy in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma
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