EUCTR2018-001028-21-NO
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- MedImmune, LLC
- Enrollment
- 195
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \= 18
- •2\. Written and signed informed consent must be obtained
- •3\. ECOG Performance Status 0 or 1
- •4\. Weight \= 35 kg
- •5\. Subjects must have histologically or cytologically confirmed pancreatic adenocarcinoma:
- •Cohort A: Subjects with previously untreated metastatic pancreatic adenocarcinoma (1 line metastatic disease) not previously treated with systemic therapies.
- •Cohort B: Subjects with metastatic pancreatic adenocarcinoma previously treated with gemcitabine\-based chemotherapy (without exposure to 5\-FU, capecitabine, oxaliplatin) 2 line metastatic adenocarcinoma
- •6\. Subjects must have at least 1 measurable lesion according to RECIST v1\.1
- •7\. All subjects must consent to providing archival tumor specimens
- •Are the trial subjects under 18? no
Exclusion Criteria
- •1\. 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.
- •2\. Prior receipt of any immune\-related therapy
- •3\. Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed
- •4\. Subjects with a history of venous thrombosis within the past 3 months
- •5\. Subjects with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 3 months prior to start of treatment
- •6\. Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
- •7\. Other invasive malignancy within 2 years.
- •8\. Any history of leptomeningeal disease or cord compression.
- •9\. Current or prior use of immunosuppressive medication within 14 days prior to the first dose
Outcomes
Primary Outcomes
Not specified
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