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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03611556
Registration number
NCT03611556
Ethics application status
Date submitted
18/05/2018
Date registered
2/08/2018
Date last updated
3/10/2023
Titles & IDs
Public title
MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.
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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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Secondary ID [1]
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D6070C00005
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Secondary ID [2]
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D6070C00005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma
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Metastatic Pancreatic Adenocarcinoma
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Oleclumab
Treatment: Drugs - Durvalumab
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Folinic acid
Treatment: Drugs - 5-FU
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.
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.
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.
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.
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.
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.
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.
Treatment: Drugs: Oleclumab
Participants will receive IV infusion of oleclumab as stated in arm description.
Treatment: Drugs: Durvalumab
Participants will receive IV infusion of durvalumab as stated in arm description.
Treatment: Drugs: Gemcitabine
Participants will receive IV infusion of gemcitabine as stated in arm description.
Treatment: Drugs: Nab-paclitaxel
Participants will receive IV infusion of nab-paclitaxel as stated in arm description.
Treatment: Drugs: Oxaliplatin
Participants will receive IV infusion of oxaliplatin as stated in arm description.
Treatment: Drugs: Folinic acid
Participants will receive IV infusion of folinic acid as stated in arm description.
Treatment: Drugs: 5-FU
Participants will receive IV infusion of 5-FU as stated in arm description.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase
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Assessment method [1]
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An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
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Timepoint [1]
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Day 1 through 65.7 weeks (maximum observed duration)
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Primary outcome [2]
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Number of Participants With Dose-limiting Toxicities (DLTs) in Dose Escalation Phase
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Assessment method [2]
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DLT: Any study drug related Grade (G)3 or higher toxicity including: any G4 immune-mediated AEs, >=G3 colitis/pneumonitis/interstitial lung disease (ILD), >=G3 nausea/vomiting/diarrhea that does not resolve to G2 or less within 3 days of maximal supportive care (MSC), G2 pneumonitis/ILD that does not resolve within 7 days of initiation of MSC, G4 anemia, G3 anemia with clinical sequelae/requires >2 units of red blood cells transfusion, G4 thrombocytopenia/neutropenia >=7 days, G3/4 thrombocytopenia with >=G3 hemorrhage, G4 febrile neutropenia (FN), G3 FN lasting >=5 days while receiving MSC, isolated G3 liver transaminase elevation (LTE)/ isolated G3 total bilirubin (TBL) that does not downgrade to G1 or less within 14 days of onset, isolated G4 LTE or TBL, elevated aspartate aminotransferase/alanine aminotransferase >3×upper limit of normal (ULN) and concurrent TBL >2×ULN without cholestasis or alternative explanations, any other toxicity judged as a DLT by Dose Escalation Committee.
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Timepoint [2]
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From Day 1 to 28 days after the first dose of study drugs
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Primary outcome [3]
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Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Escalation Phase
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Assessment method [3]
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Number of participants with abnormal vital signs (temperature, blood pressure, pulse rate, and respiratory rate) reported as TEAEs are reported.
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Timepoint [3]
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Day 1 through 65.7 weeks (maximum observed duration)
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Primary outcome [4]
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Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Dose Escalation Phase
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Assessment method [4]
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Number of participants with abnormal ECG parameters reported as TEAEs are reported.
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Timepoint [4]
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Day 1 through 65.7 weeks (maximum observed duration)
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Primary outcome [5]
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Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Escalation Phase
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Assessment method [5]
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0
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.
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Timepoint [5]
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Day 1 through 65.7 weeks (maximum observed duration)
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Primary outcome [6]
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Percentage of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Dose Expansion Phase
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Assessment method [6]
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The OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions (TLs) and non-target lesions (NTLs), any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters (SoD) of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported.
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Timepoint [6]
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Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
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Secondary outcome [1]
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Number of Participants With TEAEs and TESAEs in Dose Expansion Phase
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Assessment method [1]
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An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
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Timepoint [1]
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Day 1 through 172.1 weeks (maximum observed duration)
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Secondary outcome [2]
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Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Expansion Phase
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Assessment method [2]
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Number of participants with abnormal vital signs (temperature, blood pressure, pulse rate, and respiratory rate) reported as TEAEs are reported.
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Timepoint [2]
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0
Day 1 through 172.1 weeks (maximum observed duration)
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Secondary outcome [3]
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Number of Participants With Abnormal ECG Parameters Reported as TEAEs in Dose Expansion Phase
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Assessment method [3]
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0
Number of participants with abnormal ECG parameters reported as TEAEs are reported.
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Timepoint [3]
0
0
Day 1 through 172.1 weeks (maximum observed duration)
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Secondary outcome [4]
0
0
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Expansion Phase
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Assessment method [4]
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0
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.
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Timepoint [4]
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Day 1 through 172.1 weeks (maximum observed duration)
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Secondary outcome [5]
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Percentage of Participants With OR According to RECIST v1.1 in Dose Escalation Phase
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Assessment method [5]
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The OR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported.
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Timepoint [5]
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0
Baseline (Days -28 to -1) through 24.5 months (maximum observed duration)
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Secondary outcome [6]
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Percentage of Participants With Disease Control (DC) According to RECIST v1.1 in Dose Escalation Phase
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Assessment method [6]
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The DC is defined as confirmed CR, PR, or stable disease (SD) (maintained for >=8 weeks). The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis <10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from date of first documentation. The SD is defined as neither sufficient shrinkage of TLs to qualify for PR nor sufficient increase of TLs to qualify for progressive disease (PD), taking as reference the smallest SoD while on study, and no new lesions. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Percentage of participants with DC is reported.
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Timepoint [6]
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Baseline (Days -28 to -1) through 24.5 months (maximum observed duration)
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Secondary outcome [7]
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Number of Participants With Overall Survival Events in Dose Expansion Phase
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Assessment method [7]
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The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed using the Kaplan-Meier method. The number of participants with overall survival events (deaths) is reported.
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Timepoint [7]
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Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)
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Secondary outcome [8]
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Overall Survival in Dose Expansion Phase
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Assessment method [8]
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The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed using the Kaplan-Meier method.
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Timepoint [8]
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0
Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)
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Secondary outcome [9]
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Number of Participants With Progression-free Survival Events According to RECIST v1.1 in Dose Expansion Phase
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Assessment method [9]
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Progression-free survival (PFS) is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant received subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in sum of the diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of sum of the diameters, or unequivocal progression of existing non-target lesions, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST v1.1 assessment. The PFS is assessed using the Kaplan-Meier method. The number of participants with PFS events is reported.
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Timepoint [9]
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Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
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Secondary outcome [10]
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Progression-free Survival According to RECIST v1.1 in Dose Expansion Phase
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Assessment method [10]
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The PFS is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant received subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in sum of the diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of sum of the diameters, or unequivocal progression of existing non-target lesions, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST v1.1 assessment. The PFS is assessed using the Kaplan-Meier method.
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Timepoint [10]
0
0
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
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Secondary outcome [11]
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0
Duration of Response (DoR) According to RECIST v1.1 in Dose Expansion Phase
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Assessment method [11]
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The DoR is defined as the time from the first documentation of an OR until the first documentation of a PD or death due to any cause, whichever occurs first. The OR is defined as best overall response of confirmed CR or PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. The DoR is assessed using the Kaplan-Meier method.
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Timepoint [11]
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0
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
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Secondary outcome [12]
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0
Percentage of Participants With DC According to RECIST v1.1 in Dose Expansion Phase
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Assessment method [12]
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0
The DC is defined as confirmed CR, PR, or stable disease (SD) (maintained for >=8 weeks). The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis <10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from date of first documentation. The SD is defined as neither sufficient shrinkage of TLs to qualify for PR nor sufficient increase of TLs to qualify for PD, taking as reference the smallest SoD while on study, and no new lesions. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Percentage of participants with DC is reported.
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Timepoint [12]
0
0
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
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Secondary outcome [13]
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0
Percentage of Participants With OR According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase
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Assessment method [13]
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0
The OR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis <10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The OR is assessed by cluster of differentiation 73 (CD73) expression level either low or high at baseline. The CD73 low is defined as no CD73 expression in tumor cells or <50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in >=50% of tumor cells.
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Timepoint [13]
0
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Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
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Secondary outcome [14]
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Number of Participants With Overall Survival Events by CD73 Expression at Baseline in Dose Expansion Phase
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Assessment method [14]
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0
The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed by CD73 expression level either low or high at baseline using the Kaplan-Meier method. The CD73 low is defined as no CD73 expression in tumor cells or <50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in >=50% of tumor cells. The number of participants with overall survival events (deaths) is reported.
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Timepoint [14]
0
0
Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)
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Secondary outcome [15]
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0
Overall Survival by CD73 Expression at Baseline in Dose Expansion Phase
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Assessment method [15]
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0
The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed by CD73 expression level either low or high at baseline using the Kaplan-Meier method. The CD73 low is defined as no CD73 expression in tumor cells or <50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in >=50% of tumor cells.
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Timepoint [15]
0
0
Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)
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Secondary outcome [16]
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Number of Participants With Progression-free Survival Events According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase
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Assessment method [16]
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PFS: Time from randomization until first documentation of PD/death due to any cause, whichever occurred first, regardless of whether participant received subsequent anticancer treatment prior to progression. PD:>=20% increase in SoD of TLs and an absolute increase of >= 5 mm of SoD/unequivocal progression of existing NTLs/appearance of new lesion. Participants who had no documented progression and were still alive at the time of analysis were censored at time of latest date of assessment from their last evaluable RECIST v1.1 assessment. PFS is assessed by CD73 expression level either low/high at baseline using Kaplan-Meier method. CD73 low: No CD73 expression in tumor cells/<50% of tumor cells with 2+/3+ intensity. CD73 high: CD73 expression with 2+/3+ intensity in >=50% of tumor cells. Number of participants with PFS events is reported.
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Timepoint [16]
0
0
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
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Secondary outcome [17]
0
0
Progression-free Survival According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase
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Assessment method [17]
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0
The PFS is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant receives subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at time of analysis were censored at time of latest date of assessment from their last evaluable RECIST v1.1 assessment. PFS is assessed by CD73 expression level either low/high at baseline using Kaplan-Meier method. CD73 low: No CD73 expression in tumor cells/<50% of tumor cells with 2+/3+ intensity. CD73 high: CD73 expression with 2+/3+ intensity in >=50% of tumor cells.
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Timepoint [17]
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0
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
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Secondary outcome [18]
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Number of Participants With Positive Anti-drug Antibodies (ADA) to Oleclumab
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Assessment method [18]
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Number of participants with positive ADA to oleclumab are reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >= 2 post-baseline assessments (with <16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA positive titer that was boosted to a 4-fold or higher level following drug administration.
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Timepoint [18]
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Day 1 through 172.1 weeks (Pre-dose on Cycle [C] 1 Day [D] 1, C2D1, C3D1, Day 1 of every 3 cycles starting with C5, through 12 weeks post last dose of oleclumab)
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Secondary outcome [19]
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Number of Participants With Positive ADA to Durvalumab
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Assessment method [19]
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Number of participants with positive ADA to durvalumab are reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >= 2 post-baseline assessments (with <16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA positive titer that was boosted to a 4-fold or higher level following drug administration.
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Timepoint [19]
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Day 1 through 128 weeks (Pre-dose on C1D1, C2D1, C3D1, Day 1 of every 3 cycles starting with C5, through 12 weeks post last dose of durvalumab)
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Secondary outcome [20]
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Serum Concentrations of Oleclumab
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Assessment method [20]
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Serum concentrations of oleclumab are reported.
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Timepoint [20]
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Ten minutes (mins) (± 5 mins) post end of infusion (EOI), approximately 1 hour (+ 15 mins) after start of infusion on C1D1, C3D1, and C5D1; and pre-dose on C3D1 and C5D1
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Secondary outcome [21]
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0
Serum Concentrations of Durvalumab
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Assessment method [21]
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Serum concentrations of durvalumab are reported.
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Timepoint [21]
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0
Ten mins (± 5 mins) post EOI, approximately 1 hour (+ 15 mins) after start of infusion on C1D1 and C5D1; and pre-dose on C2D1 and C5D1
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Secondary outcome [22]
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0
Plasma Concentrations of Gemcitabine and Metabolite 2',2'-Difluorodeoxyuridine (dFdU)
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Assessment method [22]
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Plasma concentrations of gemcitabine and metabolite dFdU are reported.
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Timepoint [22]
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0
Ten mins (± 5 mins) post EOI, approximately 30-40 mins after start of infusion on C1D1 and C4D1; and pre-dose on C4D1
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Secondary outcome [23]
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0
Plasma Concentrations of Nab-paclitaxel
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Assessment method [23]
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Plasma concentrations of nab-paclitaxel are reported.
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Timepoint [23]
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0
Ten mins (± 5 mins) post EOI, approximately 30-40 mins after start of infusion on C1D1 and C4D1; and pre-dose on C4D1
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Eligibility
Key inclusion criteria
1. Age >= 18
2. Written and signed informed consent must be obtained
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
4. Weight >= 35 kg
5. 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
6. Participants must have at least 1 measurable lesion according to RECIST v1.1
7. All Participants must consent to providing archival tumor specimens.
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Minimum age
18
Years
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Maximum age
101
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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. Participants with a history of venous thrombosis within the past 3 months
5. Participants 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/06/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
22/07/2022
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Sample size
Target
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Accrual to date
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Final
213
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
0
0
Research Site - Blacktown
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Recruitment hospital [2]
0
0
Research Site - Clayton
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Recruitment hospital [3]
0
0
Research Site - Heidelberg
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Recruitment hospital [4]
0
0
Research Site - St Leonards
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Recruitment postcode(s) [1]
0
0
2148 - Blacktown
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Recruitment postcode(s) [2]
0
0
3168 - Clayton
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Recruitment postcode(s) [3]
0
0
3084 - Heidelberg
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Recruitment postcode(s) [4]
0
0
2065 - St Leonards
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Colorado
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Georgia
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Massachusetts
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Michigan
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Country [7]
0
0
United States of America
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State/province [7]
0
0
New York
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Country [8]
0
0
United States of America
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State/province [8]
0
0
North Carolina
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Ohio
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Pennsylvania
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Tennessee
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Texas
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Virginia
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Washington
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Wisconsin
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Country [16]
0
0
Norway
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State/province [16]
0
0
Oslo
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Country [17]
0
0
Spain
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State/province [17]
0
0
Barcelona
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Country [18]
0
0
Spain
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State/province [18]
0
0
Fuenlabrada
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Country [19]
0
0
Spain
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State/province [19]
0
0
Oviedo
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Country [20]
0
0
Spain
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State/province [20]
0
0
Pamplona
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
MedImmune LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The objective of this study is to evaluate the safety, tolerability, and antitumor activity
of oleclumab (MEDI9447) in combination with or without durvalumab plus chemotherapy in
participants with metastatic pancreatic cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03611556
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03611556
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