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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
Active
Cancer Type
Pancreatic Cancer
Unknown Primary
Trial Phase
Phase I
Phase II
Eligibility
18 - 101 Years, Male and Female
Study Type
Treatment
NCD ID
NCT03611556
Protocol IDs
D6070C00005 (primary)
NCI-2018-01724
D6070C00005
Study Sponsor
MedImmune Inc

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 subjects with metastatic pancreatic cancer.

Objectives

This is a Phase 1b/2, multicenter, open-label, dose-escalation, and dose-expansion study to assess the safety, preliminary antitumor activity, immunogenicity, and PK of oleclumab with or without durvalumab in combination with chemotherapy administered in subjects with metastatic PDAC. Subjects with previously untreated metastatic PDAC (1L metastatic PDAC) with be enrolled in Cohort A. Subjects with metastatic PDAC previously treated with gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, or oxaliplatin, 2L metastatic PDAC) will be enrolled in Cohort B. The study consists of 2 parts, dose escalation (part 1) and dose expansion (Part 2).
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