Pancreatic Ductal Adenocarcinoma MedDRA version: 20.0 Level: LLT Classification code 10051971 Term: Pancreatic adenocarcinoma System Organ Class: 100000004864
Conditions
Sponsors
MedImmune, LLC
Eligibility
Sex/Gender
All
Inclusion 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 Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 122 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 82
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of oleclumab plus durvalumab in combination with chemotherapy administered in subjects with metastatic PDAC. To evaluate the preliminary antitumor activity of oleclumab with or without durvalumab in combination with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel administered in subjects with 1L metastatic PDAC. To evaluate the preliminary antitumor activity of oleclumab with or without durvalumab in combination with mFOLFOX compared to mFOLFOX administered in subjects with 2L metastatic PDAC.;Secondary Objective: To assess the safety and tolerability of oleclumab with or without durvalumab in combination with chemotherapy administered in subjects with metastatic PDAC. To evaluate the preliminary antitumor activity of oleclumab with or without durvalumab in combination with chemotherapy administered in subjects with 1L metastatic PDAC and in subjects with 2L metastatic PDAC. To evaluate the preliminary antitumor activity of oleclumab with or without durvalumab in combination with chemotherapy compared to chemotherapy alone in the population defined by CD73 expression. To determine the PK profile of oleclumab and durvalumab in combination with chemotherapy administered in subjects with metastatic PDAC.;Primary end point(s): 1. Incidence of adverse events as a measure of safety of oleclumab plus durvalumab in combination with chemotherapy in dose escalation as assessed by the presence of adverse events (AEs), serious adverse events (SAEs), dose limiting toxicities (DLTs) and clinically meaningful changes from baseline of laboratory and physical assessments 2. Objective response rate as a measure of antitumor activity of oleclumab with or without durvalumab in combination with chemotherapy in dose expansion according to RECIST v1.1;Timepoint(s) of evaluation of this end point: 1. Safety assessment from time of informed consent through 12 weeks after last dose of investigational product 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Incidence of adverse events (AEs), serious adverse events (SAEs), and clinically meaningful changes from baseline of laboratory and physical assessments in dose expansion 2. Objective response rate (OR) and disease control (DC) according to RECIST v1.1 in dose escalation 3. Overall Survival (OS); Progression Free Survival (PFS), Duration of Response (DoR), and Disease Control (DC), defined as complete response (CR), partial response (PR) or stable disease (SD) according to RECIST v1.1 in dose expansion 4. Overall Survival (OS); Objective Response (OR) and Progression-Free Survival (PFS) according to RECIST v1.1 by CD73 expression at baseline 5. Immunogenicity. Development of detectable anti-drug antibody(ADA) to oleclumab (MEDI9447) and durvalumab 6. Pharmacokinetic. Measure of serum Oleclumab (MEDI9447), durvalumab and selected chemotherapies and /or their metabolites;Timepoint(s) of evaluation of this end point: 1. From time of informed consent through 12 weeks after last dose of investigational product 2. During treatment through study completion, about 2 years after the last subject dosed 3. During treatment through study completion, about 2 years after the last subject dosed 4. From time of screening through study completion, about 2 years after the last subject dosed 5. From start of treatment through 12 weeks post last dose of investigational product 6. During treatment through 12 weeks post last dose of investigational product and through the first 12 weeks of treatment for chemotherapies | — |
Countries
Australia, Norway, Spain, United States
Contacts
Public ContactClinical Trial Enquiries
MedImmune LLC
Outcome results
None listed