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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

No Placebo-Only Group

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 weeks3 visits

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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

Nab-paclitaxel

2014

Completed Phase 3

~1950

Folinic acid

2018

Completed Phase 3

~1860