Clinical trial
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
Name
D6070C00005
Description
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.
Trial arms
Trial start
2018-06-21
Estimated PCD
2022-07-22
Trial end
2022-07-22
Status
Completed
Phase
Early phase I
Treatment
Oleclumab
Participants will receive IV infusion of oleclumab as stated in arm description.
Arms:
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + nab-paclitaxel, Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX, Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel, Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX, Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel, Dose-expansion, Oleclumab 3000 mg + Gemcitabine + nab-paclitaxel
Other names:
MEDI9447
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arm description.
Arms:
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + nab-paclitaxel, Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX, Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel, Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX, Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel
Other names:
MEDI4736
Gemcitabine
Participants will receive IV infusion of gemcitabine as stated in arm description.
Arms:
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + nab-paclitaxel, Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel, Dose-expansion, Gemcitabine + nab-paclitaxel, Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel, Dose-expansion, Oleclumab 3000 mg + Gemcitabine + nab-paclitaxel
Nab-paclitaxel
Participants will receive IV infusion of nab-paclitaxel as stated in arm description.
Arms:
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + nab-paclitaxel, Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel, Dose-expansion, Gemcitabine + nab-paclitaxel, Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel, Dose-expansion, Oleclumab 3000 mg + Gemcitabine + nab-paclitaxel
Oxaliplatin
Participants will receive IV infusion of oxaliplatin as stated in arm description.
Arms:
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX, Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX
Other names:
Modified FOLFOX (oxaliplatin, folinic acid, and 5-FU)
Folinic acid
Participants will receive IV infusion of folinic acid as stated in arm description.
Arms:
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX, Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX
Other names:
Modified FOLFOX (oxaliplatin, folinic acid, and 5-FU)
5-FU
Participants will receive IV infusion of 5-FU as stated in arm description.
Arms:
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX, Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX
Other names:
Modified FOLFOX (oxaliplatin, folinic acid, and 5-FU)
Size
213
Primary endpoint
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase
Day 1 through 65.7 weeks (maximum observed duration)
Number of Participants With Dose-limiting Toxicities (DLTs) in Dose Escalation Phase
From Day 1 to 28 days after the first dose of study drugs
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Escalation Phase
Day 1 through 65.7 weeks (maximum observed duration)
Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Dose Escalation Phase
Day 1 through 65.7 weeks (maximum observed duration)
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Escalation Phase
Day 1 through 65.7 weeks (maximum observed duration)
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
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
Eligibility criteria
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.
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 213, 'type': 'ACTUAL'}}
Updated at
2023-10-03
1 organization
7 products
1 abstract
2 indications
Organization
MedImmuneProduct
GemcitabineIndication
cancerIndication
Pancreatic CancerProduct
OleclumabProduct
DurvalumabProduct
Nab-paclitaxelProduct
OxaliplatinProduct
Folinic acidProduct
5-FUAbstract
Safety and clinical activity of oleclumab (O) ± durvalumab (D) + chemotherapy (CT) in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC): A phase 1b/2 randomized study.Org: Fred Hutchinson Cancer Center/Division of Hematology and Oncology, University of Virginia Comprehensive Cancer Center, University of Michigan Health System Comprehensive Cancer Center, Hospital Universitari Vall d'Hebron Research Institute, Roswell Park Cancer Institute,