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Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel for Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by MedImmune LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights

Study Summary

This trial is testing a new cancer drug, oleclumab, to see if it is safe and effective when used with other treatments for pancreatic cancer.

Eligible Conditions
  • Cancer
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Escalation Phase
Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Dose Escalation Phase
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Escalation Phase
+3 more
Secondary outcome measures
Duration of Response (DoR) According to RECIST v1.1 in Dose Expansion Phase
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Expansion Phase
Number of Participants With Abnormal ECG Parameters Reported as TEAEs in Dose Expansion Phase
+20 more

Trial Design

7Treatment groups
Experimental Treatment
Active Control
Group I: Dose-expansion, Oleclumab 3000 mg + Gemcitabine + nab-paclitaxelExperimental Treatment3 Interventions
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.
Group II: Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxelExperimental Treatment4 Interventions
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.
Group III: Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOXExperimental Treatment5 Interventions
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.
Group IV: Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxelExperimental Treatment4 Interventions
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.
Group V: Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOXExperimental Treatment5 Interventions
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.
Group VI: Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + nab-paclitaxelExperimental Treatment4 Interventions
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.
Group VII: Dose-expansion, Gemcitabine + nab-paclitaxelActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oleclumab
2015
Completed Phase 2
~880
Nab-paclitaxel
2014
Completed Phase 3
~2030
Folinic acid
2012
Completed Phase 3
~1290
Oxaliplatin
2011
Completed Phase 4
~2560
Durvalumab
2017
Completed Phase 2
~3870
Gemcitabine
2017
Completed Phase 3
~2070
5-FU
2014
Completed Phase 3
~3420

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Who is running the clinical trial?

MedImmune LLCLead Sponsor
347 Previous Clinical Trials
793,696 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.
2018. "MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03611556.
~31 spots leftby Apr 2025
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