NCT03611556

MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 101 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 1b/2, multicenter, open-label, dose-escalation, and dose-expansion study to assess the safety, preliminary antitumor activity, immunogenicity, and pharmacokinetics (PK) of oleclumab with or without durvalumab in combination with chemotherapy administered in participants with metastatic pancreatic ductal adenocarcinoma (PDAC). Participants with previously untreated metastatic PDAC (first-line \[1L\] metastatic PDAC) will be enrolled in Cohort A. Participants with metastatic PDAC previously treated with gemcitabine-based chemotherapy (without exposure to 5-fluorouracil \[5-FU\], capecitabine, or oxaliplatin; second-line \[2L\] metastatic PDAC) will be enrolled in Cohort B. The study consists of 2 parts, dose escalation (Part 1) and dose expansion (Part 2).

Conditions

• Carcinoma
• Metastatic Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Oleclumab	Participants will receive IV infusion of oleclumab as stated in arm description.
DRUG	Durvalumab	Participants will receive IV infusion of durvalumab as stated in arm description.
DRUG	Gemcitabine	Participants will receive IV infusion of gemcitabine as stated in arm description.
DRUG	Nab-paclitaxel	Participants will receive IV infusion of nab-paclitaxel as stated in arm description.
DRUG	Oxaliplatin	Participants will receive IV infusion of oxaliplatin as stated in arm description.
DRUG	Folinic acid	Participants will receive IV infusion of folinic acid as stated in arm description.
DRUG	5-FU	Participants will receive IV infusion of 5-FU as stated in arm description.

Timeline

• Start date: 2018-06-21
• Primary completion: 2022-07-22
• Completion: 2022-07-22
• First posted: 2018-08-02
• Last updated: 2023-10-03
• Results posted: 2023-10-03

Locations

27 sites across 4 countries: United States, Australia, Norway, Spain

Regulatory

• FDA-regulated drug study