D6070C00005 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18-101Age 18-101

Pancreas<br/>CancersCancer LocationPancreas
Cancers

Systemic therapy | Stomach and upper gastrointestinal tractPancreas

Trial Overview Read MoreRead more

This phase I/II trial is evaluating two immunotherapy drugs (MEDI9447 and durvalumab) given alone or in combination, with chemotherapy, in patients with pancreatic cancer that has spread to other parts of the body.
 

This trial is treating patients with pancreatic cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

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

Commercial Sponsor

MedImmune, LLC

Summary

Participants in this trial will be randomised into one of 6 Arms of treatment, across two distinct cohorts. In cohort A, patients must have previously untreated metastatic pancreatic cancer (1st line metastatic disease). In Cohort B, patients with metastatic pancreatic cancer may have been previously treated with gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, oxaliplatin) 2nd line metastatic disease. Two Arms across Cohort A and B (Arm A1 and Arm B1) will act as a comparators to the trial treatment, in which participants will either receive gemcitabine and nab-paclitaxel or mFOLFOX chemotherapy. In Arm A2 participants will receive gemcitabine and nab-paclitaxel plus MEDI9447, and in Arm A3 participants will also receive durvalumab on top of the Arm A2 treatment. In Arm B2 participants will receive mFOLXFOX chemotherapy plus MEDI9447, and in Arm B3 participants will also receive durvalumab on top of the Arm B2 treatment. All treatment will be given until disease progression.

Recruiting Hospitals Read MoreRead more

Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Monash Health, Medical Oncology
Clayton
GI Research Study Coordinator
gi.oncresearch@monashhealth.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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