MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.
Study identifier:D6070C00005
ClinicalTrials.gov identifier:NCT03611556
EudraCT identifier:2018-001028-21
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
Oleclumab, Durvalumab, Gemcitabine, Nab-paclitaxel, Oxaliplatin, Folinic acid, 5-FU
Sex
All
Actual Enrollment
213
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 2023 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + nab-paclitaxel Participants with 1L metastatic disease will receive intravenous (IV) infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then every 4 weeks (Q4W) in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met. | Drug: Oleclumab Participants will receive IV infusion of oleclumab as stated in arm description. Other Name: MEDI9447 Drug: Durvalumab Participants will receive IV infusion of durvalumab as stated in arm description. Other Name: MEDI4736 Drug: Gemcitabine Participants will receive IV infusion of gemcitabine as stated in arm description. Drug: Nab-paclitaxel Participants will receive IV infusion of nab-paclitaxel as stated in arm description. |
| Experimental: Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel Participants with 1L metastatic disease will receive IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met. | Drug: Oleclumab Participants will receive IV infusion of oleclumab as stated in arm description. Other Name: MEDI9447 Drug: Durvalumab Participants will receive IV infusion of durvalumab as stated in arm description. Other Name: MEDI4736 Drug: Gemcitabine Participants will receive IV infusion of gemcitabine as stated in arm description. Drug: Nab-paclitaxel Participants will receive IV infusion of nab-paclitaxel as stated in arm description. |
| Experimental: Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX Participants with 2L metastatic disease will receive IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met. | Drug: Oleclumab Participants will receive IV infusion of oleclumab as stated in arm description. Other Name: MEDI9447 Drug: Durvalumab Participants will receive IV infusion of durvalumab as stated in arm description. Other Name: MEDI4736 Drug: Oxaliplatin Participants will receive IV infusion of oxaliplatin as stated in arm description. Other Name: Modified FOLFOX (oxaliplatin, folinic acid, and 5-FU) Drug: Folinic acid Participants will receive IV infusion of folinic acid as stated in arm description. Other Name: Modified FOLFOX (oxaliplatin, folinic acid, and 5-FU) Drug: 5-FU Participants will receive IV infusion of 5-FU as stated in arm description. Other Name: Modified FOLFOX (oxaliplatin, folinic acid, and 5-FU) |
| Experimental: Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX Participants with 2L metastatic disease will receive IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met. | Drug: Oleclumab Participants will receive IV infusion of oleclumab as stated in arm description. Other Name: MEDI9447 Drug: Durvalumab Participants will receive IV infusion of durvalumab as stated in arm description. Other Name: MEDI4736 Drug: Oxaliplatin Participants will receive IV infusion of oxaliplatin as stated in arm description. Other Name: Modified FOLFOX (oxaliplatin, folinic acid, and 5-FU) Drug: Folinic acid Participants will receive IV infusion of folinic acid as stated in arm description. Other Name: Modified FOLFOX (oxaliplatin, folinic acid, and 5-FU) Drug: 5-FU Participants will receive IV infusion of 5-FU as stated in arm description. Other Name: Modified FOLFOX (oxaliplatin, folinic acid, and 5-FU) |
| Active Comparator: Dose-expansion, Gemcitabine + nab-paclitaxel Participants with 1L metastatic disease will receive IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met. | Drug: Gemcitabine Participants will receive IV infusion of gemcitabine as stated in arm description. Drug: Nab-paclitaxel Participants will receive IV infusion of nab-paclitaxel as stated in arm description. |
| Experimental: Dose-expansion, Oleclumab 3000 mg + Gemcitabine + nab-paclitaxel Participants with 1L metastatic disease will receive IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met. | Drug: Oleclumab Participants will receive IV infusion of oleclumab as stated in arm description. Other Name: MEDI9447 Drug: Gemcitabine Participants will receive IV infusion of gemcitabine as stated in arm description. Drug: Nab-paclitaxel Participants will receive IV infusion of nab-paclitaxel as stated in arm description. |
| Experimental: Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel Participants with 1L metastatic disease will receive IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met. | Drug: Oleclumab Participants will receive IV infusion of oleclumab as stated in arm description. Other Name: MEDI9447 Drug: Durvalumab Participants will receive IV infusion of durvalumab as stated in arm description. Other Name: MEDI4736 Drug: Gemcitabine Participants will receive IV infusion of gemcitabine as stated in arm description. Drug: Nab-paclitaxel Participants will receive IV infusion of nab-paclitaxel as stated in arm description. |
