Phase 2
Completed N=195
MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.
Carcinoma · Pancreatic Cancer
Source: ClinicalTrials.gov NCT03611556 ↗
Enrolled (actual)
195
Serious AEs
55.9%
Results posted
Oct 2023
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase — 7; 7; 3; 8 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase |
7; 7; 3; 8; 4; 6 | — |
| PRIMARY Number of Participants With Dose-limiting Toxicities (DLTs) in Dose Escalation Phase |
0; 0; 0; 1 | — |
| PRIMARY Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Escalation Phase |
3; 3; 0; 1; 1; 0 | — |
| PRIMARY Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Dose Escalation Phase |
0; 1; 0; 0; 0; 1 | — |
| PRIMARY Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Escalation Phase |
3; 3; 1; 0; 2; 2 | — |
| PRIMARY 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 |
29.0; 21.1; 32.9 | 0.3614 |
| SECONDARY Number of Participants With TEAEs and TESAEs in Dose Expansion Phase |
62; 37; 70; 34; 24; 37 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Expansion Phase |
0; 0; 1; 15; 12; 21 | — |
| SECONDARY Number of Participants With Abnormal ECG Parameters Reported as TEAEs in Dose Expansion Phase |
0; 1; 0; 2; 3; 3 | — |
| SECONDARY Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Expansion Phase |
17; 14; 28; 0; 1; 3 | — |
| SECONDARY Percentage of Participants With OR According to RECIST v1.1 in Dose Escalation Phase |
0; 14.3; 0; 12.5 | — |
| SECONDARY Percentage of Participants With Disease Control (DC) According to RECIST v1.1 in Dose Escalation Phase |
42.9; 71.4; 66.7; 62.5 | — |
| SECONDARY Number of Participants With Overall Survival Events in Dose Expansion Phase |
47; 32; 53 | — |
| SECONDARY Overall Survival in Dose Expansion Phase |
10.8; 8.9; 12.9 | — |
| SECONDARY Number of Participants With Progression-free Survival Events According to RECIST v1.1 in Dose Expansion Phase |
43; 32; 51 | — |
| SECONDARY Progression-free Survival According to RECIST v1.1 in Dose Expansion Phase |
6.7; 5.6; 7.5 | — |
| SECONDARY Duration of Response (DoR) According to RECIST v1.1 in Dose Expansion Phase |
7.2; 12.9; 9.5 | — |
| SECONDARY Percentage of Participants With DC According to RECIST v1.1 in Dose Expansion Phase |
66.1; 73.7; 75.7 | — |
| SECONDARY Percentage of Participants With OR According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase |
23.9; 22.2; 31.4; 43.8; 18.2; 36.8 | — |
| SECONDARY Number of Participants With Overall Survival Events by CD73 Expression at Baseline in Dose Expansion Phase |
37; 22; 39; 10; 10; 14 | — |
| SECONDARY Overall Survival by CD73 Expression at Baseline in Dose Expansion Phase |
9.9; 7.9; 12.1; 22.2; 16.0; 16.1 | — |
| SECONDARY Number of Participants With Progression-free Survival Events According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase |
35; 23; 39; 8; 9; 12 | — |
| SECONDARY Progression-free Survival According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase |
5.6; 5.2; 5.5; 10.5; 7.6; 10.9 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies (ADA) to Oleclumab |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Positive ADA to Durvalumab |
0; 0; 0; 0; 2; 1 | — |
| SECONDARY Serum Concentrations of Oleclumab |
297.6; 710.2; 412.7; 734.6; 704.4; 725.9 | — |
| SECONDARY Serum Concentrations of Durvalumab |
292.5; 374.5; 309.0; 380.7; 345.8; 35.97 | — |
| SECONDARY Plasma Concentrations of Gemcitabine and Metabolite 2',2'-Difluorodeoxyuridine (dFdU) |
3194; 4659; 3301; 3315; 4086; NA | — |
| SECONDARY Plasma Concentrations of Nab-paclitaxel |
1711; 2685; 2381; 2711; 2611; NA | — |
Eligibility Criteria
Inclusion Criteria
- Age >= 18
- Written and signed informed consent must be obtained
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Weight >= 35 kg
- 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
- Participants must have at least 1 measurable lesion according to RECIST v1.1
- All Participants must consent to providing archival tumor specimens.
Exclusion Criteria
- 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.
- Prior receipt of any immune-related therapy
- Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed.
- Participants with a history of venous thrombosis within the past 3 months
- Participants with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 3 months prior to start of treatment
- Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
- Other invasive malignancy within 2 years
- Any history of leptomeningeal disease or cord compression
- Current or prior use of immunosuppressive medication within 14 days prior to the first dose.
Data sourced from ClinicalTrials.gov (NCT03611556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.