Trial · NCT03611556
MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.
NCT03611556, Phase 1, Phase 2, Completed, MedImmune LLC; results first posted 2023-10-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study. Trials, record NCT03611556. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03611556
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.
- NCT number
- NCT03611556
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 213 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Carcinoma, Metastatic Pancreatic Adenocarcinoma
- Interventions
- Oleclumab, Durvalumab, Gemcitabine, Nab-paclitaxel, Oxaliplatin, Folinic acid, 5-FU
- First posted
- 2018-08-02
- Last updated
- 2023-10-03
- Other registries' IDs
- eudract:2018-001028-21
- Results first posted
- 2023-10-03
- Limitations and caveats
Dose escalation phase: Participants not enrolled in oleclumab 750 mg cohort. Dose expansion phase: Outcomes of mFOLFOX cohorts not included as enrollment was not opened. Non-compartmental PK data analysis were planned to be performed from each dose cohort if data allowed, but as sparse PK samples were collected, no non-compartmental PK parameters were calculated. Consequently, PK concentration time data only have been reported.
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | 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. |
| Primary | 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 | 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. |
| Primary | 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 vital signs (temperature, blood pressure, pulse rate, and respiratory rate) reported as TEAEs are reported. |
| Primary | 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 ECG parameters reported as TEAEs are reported. |
| Primary | Number of Participants With Abnormal Clinical Laboratory 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 are reported. |
| 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 | Baseline (Days -28 to -1) through 36.1 months (maximum observed duration) | 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. |
| Secondary | Number of Participants With TEAEs and TESAEs in Dose Expansion Phase | Day 1 through 172.1 weeks (maximum observed duration) | 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. |
| Secondary | Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Expansion Phase | Day 1 through 172.1 weeks (maximum observed duration) | Number of participants with abnormal vital signs (temperature, blood pressure, pulse rate, and respiratory rate) reported as TEAEs are reported. |
| Secondary | Number of Participants With Abnormal ECG Parameters Reported as TEAEs in Dose Expansion Phase | Day 1 through 172.1 weeks (maximum observed duration) | Number of participants with abnormal ECG parameters reported as TEAEs are reported. |
| Secondary | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Expansion Phase | Day 1 through 172.1 weeks (maximum observed duration) | Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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 | The DLT-evaluable population included all participants enrolled in the dose-escalation phase who received all planned doses of study drugs during the DLT evaluation period and completed the safety follow-up through the DLT evaluation period or experienced any DLT during the DLT-evaluation period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Escalation Phase | Day 1 through 65.7 weeks (maximum observed duration) | As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Dose Escalation Phase | Day 1 through 65.7 weeks (maximum observed duration) | As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Escalation Phase | Day 1 through 65.7 weeks (maximum observed duration) | As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Baseline (Days -28 to -1) through 36.1 months (maximum observed duration) | The intent-to treat (ITT) population included all participants who were randomized and received any study drugs and were analyzed according to randomized treatment assignment. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With TEAEs and TESAEs in Dose Expansion Phase | Day 1 through 172.1 weeks (maximum observed duration) | As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Expansion Phase | Day 1 through 172.1 weeks (maximum observed duration) | As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal ECG Parameters Reported as TEAEs in Dose Expansion Phase | Day 1 through 172.1 weeks (maximum observed duration) | As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Expansion Phase | Day 1 through 172.1 weeks (maximum observed duration) | As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group534
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase | Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | Any TEAEs | 7 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase | Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | Any TEAEs | 7 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase | Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX | Any TEAEs | 3 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase | Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX | Any TEAEs | 8 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase | Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | Any TESAEs | 4 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase | Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | Any TESAEs | 6 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase | Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX | Any TESAEs | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase | Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX | Any TESAEs | 4 | Participants | |
| Number of Participants With Dose-limiting Toxicities (DLTs) in Dose Escalation Phase | Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) in Dose Escalation Phase | Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | 0 | Participants |
1 to 10 of 534Source ClinicalTrials.gov
See all 534 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | 7 | |
| Overall Study | STARTED | Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | 7 | |
| Overall Study | STARTED | Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX | 3 | |
| Overall Study | STARTED | Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX | 8 | |
| Overall Study | STARTED | Dose-expansion, Gemcitabine + Nab-paclitaxel | 62 | |
| Overall Study | STARTED | Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel | 38 | |
| Overall Study | STARTED | Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | 70 | |
| Overall Study | COMPLETED | Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | 0 | |
| Overall Study | COMPLETED | Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | 0 | |
| Overall Study | COMPLETED | Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events3,248
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | 2 | 7 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | 2 | 7 | 13 |
| other | Neutropenia | Blood and lymphatic system disorders | Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX | 2 | 3 | 3 |
| other | Neutropenia | Blood and lymphatic system disorders | Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX | 1 | 8 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Dose-expansion, Gemcitabine + Nab-paclitaxel | 22 | 62 | 37 |
| other | Neutropenia | Blood and lymphatic system disorders | Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel | 14 | 38 | 25 |
| other | Neutropenia | Blood and lymphatic system disorders | Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | 16 | 70 | 36 |
| other | Asthenia | General disorders | Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | 2 | 7 | 2 |
| other | Asthenia | General disorders | Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | 2 | 7 | 2 |
| other | Asthenia | General disorders | Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX | 0 | 3 | 0 |
1 to 10 of 3,248Source ClinicalTrials.gov
See all 3,248 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | 7 | 7 |
| Total, all-cause mortality | Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | 7 | 7 |
| Total, all-cause mortality | Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX | 3 | 3 |
| Total, all-cause mortality | Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX | 8 | 8 |
| Total, all-cause mortality | Dose-expansion, Gemcitabine + Nab-paclitaxel | 47 | 62 |
| Total, all-cause mortality | Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel | 32 | 38 |
| Total, all-cause mortality | Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | 53 | 70 |
| Total, other adverse events | Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | 7 | 7 |
| Total, other adverse events | Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel | 7 | 7 |
| Total, other adverse events | Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX | 3 | 3 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT03611556/registered?page=2