MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.
Study identifier:D6070C00005
ClinicalTrials.gov identifier:NCT03611556
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official 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
Medical condition
Carcinoma
Phase
Phase 1/2
Healthy volunteers
No
Study drug
gemcitabine, nab-paclitaxel, oxaliplatin, leucovorin, 5-FU
Sex
All
Actual Enrollment
212
Study type
Interventional
Age
18 Years - 101 Years
Date
Study Start Date: 21 Jun 2018
Primary Completion Date: 22 Jul 2022
Study Completion Date: 22 Jul 2022
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2022 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Arm A1 gemcitabine and nab-paclitaxel | Combination Product: gemcitabine Subjects will receive gemcitabine in combination with nab-paclitaxel and with or without oleclumab and/or durvalumab until disease progression Combination Product: nab-paclitaxel Subjects will receive nab-paclitaxel in combination with gemcitabine and with or without oleclumab and/or durvalumab until disease progression |
| Experimental: Arm A2 oleclumab (MEDI9447), gemcitabine and nab-paclitaxel | Biological/Vaccine: oleclumab Subjects will receive oleclumab with or without durvalumab and in combination with chemotherapy viz. gemcitabine and nab-paclitaxel or mFOLFOX (5FU, leucovorin and oxaliplatin) until disease progression Other Name: MEDI9447 Combination Product: gemcitabine Subjects will receive gemcitabine in combination with nab-paclitaxel and with or without oleclumab and/or durvalumab until disease progression Combination Product: nab-paclitaxel Subjects will receive nab-paclitaxel in combination with gemcitabine and with or without oleclumab and/or durvalumab until disease progression |
| Experimental: Arm A3 oleclumab (MEDI9447), durvalumab (MEDI4736), and gemcitabine/nab-paclitaxel | Biological/Vaccine: oleclumab Subjects will receive oleclumab with or without durvalumab and in combination with chemotherapy viz. gemcitabine and nab-paclitaxel or mFOLFOX (5FU, leucovorin and oxaliplatin) until disease progression Other Name: MEDI9447 Biological/Vaccine: durvalumab Subjects will receive durvalumab with oleclumab and in combination with chemotherapy viz. gemcitabine and nab-paclitaxel or mFOLFOX (5FU, leucovorin and oxaliplatin) until disease progression Other Name: MEDI4736 Combination Product: gemcitabine Subjects will receive gemcitabine in combination with nab-paclitaxel and with or without oleclumab and/or durvalumab until disease progression Combination Product: nab-paclitaxel Subjects will receive nab-paclitaxel in combination with gemcitabine and with or without oleclumab and/or durvalumab until disease progression |
| Active Comparator: Arm B1 mFOLFOX (oxaliplatin, leucovorin, 5-FU) | Combination Product: oxaliplatin Subjects will receive oxaliplatin (as part of modified FOLFOX) in combination with or without oleclumab and/or durvalumab until disease progression Other Name: Modified FOLFOX (oxaliplatin, leucovorin, and 5-FU) Combination Product: leucovorin Subjects will receive leucovorin (as part of modified FOLFOX) in combination with or without oleclumab and/or durvalumab until disease progression Other Name: Modified FOLFOX (oxaliplatin, leucovorin, and 5-FU) Combination Product: 5-FU Subjects will receive a bolus of 5-FU followed by continuous 5-FU infusion (as part of modified FOLFOX) in combination with or without oleclumab and/or durvalumab until disease progression Other Name: Modified FOLFOX (oxaliplatin, leucovorin, and 5-FU) |
| Experimental: Arm B2 oleclumab (MEDI9447) and mFOLFOX (oxaliplatin, leucovorin, 5-FU) | Biological/Vaccine: oleclumab Subjects will receive oleclumab with or without durvalumab and in combination with chemotherapy viz. gemcitabine and nab-paclitaxel or mFOLFOX (5FU, leucovorin and oxaliplatin) until disease progression Other Name: MEDI9447 Combination Product: oxaliplatin Subjects will receive oxaliplatin (as part of modified FOLFOX) in combination with or without oleclumab and/or durvalumab until disease progression Other Name: Modified FOLFOX (oxaliplatin, leucovorin, and 5-FU) Combination Product: leucovorin Subjects will receive leucovorin (as part of modified FOLFOX) in combination with or without oleclumab and/or durvalumab until disease progression Other Name: Modified FOLFOX (oxaliplatin, leucovorin, and 5-FU) Combination Product: 5-FU Subjects will receive a bolus of 5-FU followed by continuous 5-FU infusion (as part of modified FOLFOX) in combination with or without oleclumab and/or durvalumab until disease progression Other Name: Modified FOLFOX (oxaliplatin, leucovorin, and 5-FU) |
| Experimental: Arm B3 oleclumab (MEDI9447), durvalumab (MEDI4736), and mFOLFOX (oxaliplatin, leucovorin, 5-FU) | Biological/Vaccine: oleclumab Subjects will receive oleclumab with or without durvalumab and in combination with chemotherapy viz. gemcitabine and nab-paclitaxel or mFOLFOX (5FU, leucovorin and oxaliplatin) until disease progression Other Name: MEDI9447 Biological/Vaccine: durvalumab Subjects will receive durvalumab with oleclumab and in combination with chemotherapy viz. gemcitabine and nab-paclitaxel or mFOLFOX (5FU, leucovorin and oxaliplatin) until disease progression Other Name: MEDI4736 Combination Product: oxaliplatin Subjects will receive oxaliplatin (as part of modified FOLFOX) in combination with or without oleclumab and/or durvalumab until disease progression Other Name: Modified FOLFOX (oxaliplatin, leucovorin, and 5-FU) Combination Product: leucovorin Subjects will receive leucovorin (as part of modified FOLFOX) in combination with or without oleclumab and/or durvalumab until disease progression Other Name: Modified FOLFOX (oxaliplatin, leucovorin, and 5-FU) Combination Product: 5-FU Subjects will receive a bolus of 5-FU followed by continuous 5-FU infusion (as part of modified FOLFOX) in combination with or without oleclumab and/or durvalumab until disease progression Other Name: Modified FOLFOX (oxaliplatin, leucovorin, and 5-FU) |
