Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

M20-732 : A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination With Modified FOLFIRINOX (mFFX) With or Without Budigalimab Compared to mFFX in Subjects With Untreated Metastatic Pancreatic Adenocarcinoma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18-75Age 18-75

Pancreas<br/>CancersCancer LocationPancreas
Cancers

Systemic therapy | Stomach and upper gastrointestinal tractPancreas

Trial Overview Read MoreRead more

This Phase II trial is evaluating how safe and effective a targeted therapy (ABBV-927) is when combined with chemotherapy (mFFX) both with or without another targeted therapy (budigalimab), compared to mFFX alone, in adults with untreated metastatic pancreatic cancer.
 

This trial is treating patients with pancreatic cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.
  • 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 had certain treatments, surgical procedures or drugs.

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

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination With Modified FOLFIRINOX (mFFX) With or Without Budigalimab Compared to mFFX in Subjects With Untreated Metastatic Pancreatic Adenocarcinoma

Commercial Sponsor

AbbVie

Summary

This randomised, open-label trial has two phases. In the first phase (dose escalation), participants will receive escalating doses of ABBV-927 (administered intravenously [IV]), in combination with modified FOLFIRINOX (mFFX) (IV) and budigalimab (IV). The second phase has three cohorts. In Phase 2 Cohort A, participants will receive mFFX (via IV) monotherapy, on Day 1 and Day 15 of each 28 day cycle. In Phase 2 Cohort B, participants will receive mFFX (via IV) on Day 1 and Day 15, in combination with ABBV-927 (via IV) in each 28 day cycle. In Phase 2 Cohort C Expansion, participants will receive mFFX (via IV) on Day 1 and Day 15, in combination with ABBV-927 (via IV) and budigalimab (via IV) in each 28 day cycle.

Recruiting Hospitals Read MoreRead more

Austin Health
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
0436386758

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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