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History of Changes for Study: NCT03611556
MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study
Latest version (submitted June 9, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 26, 2018 None (earliest Version on record)
2 August 30, 2018 Study Status and Contacts/Locations
3 October 8, 2018 Study Status and Contacts/Locations
4 November 8, 2018 Study Status and Contacts/Locations
5 December 18, 2018 Study Status and Contacts/Locations
6 January 17, 2019 Contacts/Locations and Study Status
7 February 15, 2019 Study Status and Contacts/Locations
8 March 20, 2019 Study Status and Contacts/Locations
9 April 19, 2019 Contacts/Locations and Study Status
10 May 21, 2019 Study Status
11 July 4, 2019 Study Status, Contacts/Locations and Study Design
12 August 8, 2019 Study Status and Contacts/Locations
13 September 9, 2019 Study Status and Contacts/Locations
14 October 11, 2019 Study Status and Contacts/Locations
15 October 25, 2019 Arms and Interventions, Contacts/Locations and Study Status
16 December 4, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
17 February 11, 2020 Study Status and Study Design
18 June 4, 2020 Study Status and IPDSharing
19 September 7, 2020 Study Status
20 December 7, 2020 Recruitment Status, Study Status and Contacts/Locations
21 December 21, 2020 Study Status and Study Identification
22 January 20, 2021 Study Status
23 February 19, 2021 Study Status and Contacts/Locations
24 March 19, 2021 Study Status and Contacts/Locations
25 April 16, 2021 Study Status
26 May 14, 2021 Study Status
27 June 11, 2021 Study Status
28 July 12, 2021 Study Status and Contacts/Locations
29 August 18, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
30 March 18, 2022 Study Status, Contacts/Locations and Study Design
31 June 9, 2022 Study Status
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Study NCT03611556
Submitted Date:  July 26, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: D6070C00005
Brief Title: MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study
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
Secondary IDs: D6070C00005 [Other Grant/Funding Number: MedImmune, LLC]
Open or close this module Study Status
Record Verification: July 2018
Overall Status: Recruiting
Study Start: June 21, 2018
Primary Completion: March 24, 2021 [Anticipated]
Study Completion: March 24, 2021 [Anticipated]
First Submitted: May 18, 2018
First Submitted that
Met QC Criteria:
July 26, 2018
First Posted: August 2, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
July 26, 2018
Last Update Posted: August 2, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: MedImmune LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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 subjects with metastatic pancreatic cancer.
Detailed Description: This is a Phase 1b/2, multicenter, open-label, dose-escalation, and dose-expansion study to assess the safety, preliminary antitumor activity, immunogenicity, and PK of oleclumab with or without durvalumab in combination with chemotherapy administered in subjects with metastatic PDAC. Subjects with previously untreated metastatic PDAC (1L metastatic PDAC) with be enrolled in Cohort A. Subjects with metastatic PDAC previously treated with gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, or oxaliplatin, 2L metastatic PDAC) will be enrolled in Cohort B. The study consists of 2 parts, dose escalation (part 1) and dose expansion (Part 2).
Open or close this module Conditions
Conditions: Carcinoma
Metastatic Pancreatic Adenocarcinoma
Keywords: MEDI9447
oleclumab
immunotherapy
pancreatic cancer
durvalumab
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 6
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 204 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Arm A1
gemcitabine and nab-paclitaxel
Drug: gemcitabine
Subjects will receive gemcitabine in combination with nab-paclitaxel and with or without oleclumab and/or durvalumab until disease progression
Drug: 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: oleclumab
Subjects will receive oleclumab with or without durvalumab and in combination with or without chemotherapy gemcitabine and nab-paclitaxel or mFOLFOX (oxaliplatin, leucovorin and 5FU) until disease progression
Other Names:
  • MEDI9447
Drug: gemcitabine
Subjects will receive gemcitabine in combination with nab-paclitaxel and with or without oleclumab and/or durvalumab until disease progression
Drug: 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: oleclumab
Subjects will receive oleclumab with or without durvalumab and in combination with or without chemotherapy gemcitabine and nab-paclitaxel or mFOLFOX (oxaliplatin, leucovorin and 5FU) until disease progression
Other Names:
  • MEDI9447
Biological: durvalumab
Subjects will receive durvalumab with or without oleclumab and in combination with chemotherapy gemcitabine and nab-paclitaxel or mFOLFOX (oxaliplatin, leucovorin and 5FU) until disease progression
Other Names:
  • MEDI4736
Drug: gemcitabine
Subjects will receive gemcitabine in combination with nab-paclitaxel and with or without oleclumab and/or durvalumab until disease progression
Drug: 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 in combination with or without oleclumab and/or durvalumab until disease progression
Other Names:
  • Modified FOLFOX (oxaliplatin, leucovorin, and 5-FU)
Combination Product: leucovorin
Subjects will receive leucovorin in combination with or without oleclumab and/or durvalumab until disease progression
Other Names:
  • 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 in combination with or without oleclumab and/or durvalumab until disease progression
Other Names:
  • Modified FOLFOX (oxaliplatin, leucovorin, and 5-FU)
Experimental: Arm B2
oleclumab (MEDI9447) and mFOLFOX (oxaliplatin, leucovorin, 5-FU)
Biological: oleclumab
Subjects will receive oleclumab with or without durvalumab and in combination with or without chemotherapy gemcitabine and nab-paclitaxel or mFOLFOX (oxaliplatin, leucovorin and 5FU) until disease progression
Other Names:
  • MEDI9447
Combination Product: oxaliplatin
Subjects will receive oxaliplatin in combination with or without oleclumab and/or durvalumab until disease progression
Other Names:
  • Modified FOLFOX (oxaliplatin, leucovorin, and 5-FU)
Combination Product: leucovorin
Subjects will receive leucovorin in combination with or without oleclumab and/or durvalumab until disease progression
Other Names:
  • 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 in combination with or without oleclumab and/or durvalumab until disease progression
Other Names:
  • Modified FOLFOX (oxaliplatin, leucovorin, and 5-FU)
Experimental: Arm B3
oleclumab (MEDI9447), durvalumab (MEDI4736), and mFOLFOX (oxaliplatin, leucovorin, 5-FU)
Biological: oleclumab
Subjects will receive oleclumab with or without durvalumab and in combination with or without chemotherapy gemcitabine and nab-paclitaxel or mFOLFOX (oxaliplatin, leucovorin and 5FU) until disease progression
Other Names:
  • MEDI9447
Biological: durvalumab
Subjects will receive durvalumab with or without oleclumab and in combination with chemotherapy gemcitabine and nab-paclitaxel or mFOLFOX (oxaliplatin, leucovorin and 5FU) until disease progression
Other Names:
  • MEDI4736
Combination Product: oxaliplatin
Subjects will receive oxaliplatin in combination with or without oleclumab and/or durvalumab until disease progression
Other Names:
  • Modified FOLFOX (oxaliplatin, leucovorin, and 5-FU)
Combination Product: leucovorin
Subjects will receive leucovorin in combination with or without oleclumab and/or durvalumab until disease progression
Other Names:
  • 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 in combination with or without oleclumab and/or durvalumab until disease progression
Other Names:
  • Modified FOLFOX (oxaliplatin, leucovorin, and 5-FU)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of Adverse Events as a measure of safety in dose escalation phase
[ Time Frame: From time of informed consent through treatment period and including the follow-up period 12 weeks after last dose of investigational product, approximately 1 year ]

The primary endpoint is safety as assessed by the presence of adverse events and serious adverse events
2. Objective Response (OR) rate as a measure of antitumor activity in dose expansion phase
[ Time Frame: From start of treatment until documentation of disease progression or initiation of subsequent anticancer therapy or study completion, about 2 years after the last subject dosed, which ever comes first ]

Best overall response of confirmed CR or confirmed PR according to RECIST version 1.1
3. Incidence of clinically significant ECG abnormalities as a measure of safety in dose escalation phase
[ Time Frame: From time of informed consent through treatment period and including the follow-up period 12 weeks after last dose of investigational product, approximately 1 year ]

12 lead ECGs will be measured to identify clinical significant abnormalities including ECGs that demonstrate a QTcF value >500ms, 2 additional 12-lead ECGs should be obtained over a 30 minute time period to confirm prolongation based on the average QTcF value
4. Incidence of clinically significant laboratory values as a measure of safety in dose escalation phase
[ Time Frame: From time of informed consent through treatment period and including the follow-up period 12 weeks after last dose of investigational product, approximately 1 year ]

Assess the presence of clinically significant laboratory values from baseline
Secondary Outcome Measures:
1. Incidence of Adverse Events as a measure of safety in dose expansion phase
[ Time Frame: From time of informed consent through treatment period and including the follow-up period 12 weeks after last dose of investigational product, approximately 1 year ]

Safety as assessed by the presence of adverse events and serious adverse events
2. Objective Response (OR) rate as a measure of antitumor activity in dose escalation phase
[ Time Frame: From start of treatment until documentation of disease progression or initiation of subsequent anticancer therapy or study completion, about 2 years after the last subject dosed, which ever comes first ]

Best overall response of confirmed CR or confirmed PR according to RECIST version 1.1 in Part 1 (dose escalation)
3. Overall Survival (OS)
[ Time Frame: From time randomization until death or study completion, about 2 years after the last subject dosed ]

The time from randomization until death due to any cause in Part 2 (dose expansion)
4. Progression-Free Survival (PFS)
[ Time Frame: From start of treatment until death or study completion, about 2 years after the last subject dosed, which ever comes first ]

The time from randomization until the first documentation of disease progression or death due to any cause, whichever occurs first in Part 2 (dose expansion)
5. Duration of Response (DoR)
[ Time Frame: From time of informed consent through study completion, about 2 years after the last subject dosed ]

The duration from the first documentation of OR to the first documented disease progression or death due to any cause, whichever occurs first in Part 2 (dose expansion)
6. Disease control (DC)
[ Time Frame: During treatment through study completion, about 2 years after the last subject dosed ]

CR, PR, or SD (if subjects maintain SD for ≥ 8 weeks [± 3 days]) in Part 1 (dose escalation) in Part 2 (dose expansion)
7. Development of detectable anti-drug antibody (ADA) to oleclumab (MEDI9447)
[ Time Frame: From start of treatment through 12 weeks post last dose of investigational product ]

Immunogenicity of oleclumab
8. Development of detectable anti-drug antibody(ADA) to durvalumab
[ Time Frame: From start of treatment through 12 weeks post last dose of investigational product ]

Immunogenicity of durvalumab
9. Serum oleclumab (MEDI9447) concentration levels
[ Time Frame: During treatment through 12 weeks post last dose of investigational product ]

Pharmacokinetics of oleclumab
10. Serum durvalumab concentration levels
[ Time Frame: During treatment through 12 weeks post last dose of investigational product ]

Pharmacokinetics of durvalumab
11. Area under the curve (AUC) of selected chemo-therapies and /or their metabolites
[ Time Frame: From start of treatment through the first 16 weeks of treatment ]

Pharmacokinetics of gemcitabine and nab paclitaxel and their metabolites
12. Maximun serum concentration (Cmax) of selected chemo-therapies and /or their metabolites
[ Time Frame: From start of treatment through the first 16 weeks of treatment ]

Pharmacokinetics of gemcitabine and nab paclitaxel and their metabolites
13. Incidence of clinically significant ECG abnormalities as a measure of safety in dose expansion phase
[ Time Frame: From time of informed consent through treatment period and including the follow-up period 12 weeks after last dose of investigational product, approximately 1 year ]

12 lead ECGs will be measured to identify clinical significant abnormalities including ECGs that demonstrate a QTcF value >500ms, 2 additional 12-lead ECGs should be obtained over a 30 minute time period to confirm prolongation based on the average QTcF value
14. Incidence of clinically significant laboratory values as a measure of safety in dose expansion phase
[ Time Frame: From time of informed consent through treatment period and including the follow-up period 12 weeks after last dose of investigational product, approximately 1 year ]

Assess the presence of clinically significant laboratory values from baseline
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 101 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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 (1st 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) 2nd line metastatic disease

  6. Subjects must have at least 1 measurable lesion according to RECIST v1.1
  7. All subjects must consent to providing archival tumor specimens

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
Open or close this module Contacts/Locations
Central Contact Person: AstraZeneca Clinical Study Information Center
Telephone: 1-877-240-9479
Email: information.center@astrazeneca.com
Locations: United States, California
Research Site
[Not yet recruiting]
La Jolla, California, United States, 92093
United States, Colorado
Research Site
[Not yet recruiting]
Aurora, Colorado, United States, 80045
United States, Georgia
Research Site
[Not yet recruiting]
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Research Site
[Not yet recruiting]
Boston, Massachusetts, United States, 02215
United States, New York
Research Site
[Not yet recruiting]
Buffalo, New York, United States, 14263
United States, North Carolina
Research Site
[Not yet recruiting]
Durham, North Carolina, United States, 27710
United States, Ohio
Research Site
[Not yet recruiting]
Cincinnati, Ohio, United States, 45219
Research Site
[Not yet recruiting]
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Research Site
[Not yet recruiting]
Philadelphia, Pennsylvania, United States, 19106
Research Site
[Not yet recruiting]
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Research Site
[Recruiting]
Nashville, Tennessee, United States, 37203
United States, Texas
Research Site
[Not yet recruiting]
Dallas, Texas, United States, 75200
Research Site
[Not yet recruiting]
Houston, Texas, United States, 77030
United States, Washington
Research Site
[Not yet recruiting]
Seattle, Washington, United States, 98109
United States, Wisconsin
Research Site
[Not yet recruiting]
Madison, Wisconsin, United States, 53792
Australia
Research Site
[Not yet recruiting]
Blacktown, Australia, 2148
Research Site
[Not yet recruiting]
Clayton, Australia, 3168
Research Site
[Not yet recruiting]
Heidelberg, Australia, 3084
Research Site
[Not yet recruiting]
St Leonards, Australia, 2065
Norway
Research Site
[Not yet recruiting]
Oslo, Norway, N-0379
Spain
Research Site
[Not yet recruiting]
Barcelona, Spain, 08035
Research Site
[Not yet recruiting]
Madrid, Spain, 28942
Research Site
[Not yet recruiting]
Pamplona, Spain, 31008
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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