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NCT05330429 : A Phase 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Bevacizumab and FOLFIRI Versus Bevacizumab and FOLFIRI in Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Bowel<br/>CancersCancer LocationBowel
Cancers

Systemic therapy,Treatment | Bowel (colorectum)Colon,Colorectum,Rectum

Trial Overview Read MoreRead more

This phase II study is seeking to determine how safe and tolerable, and what the best dose level is, of targeted therapy (magrolimab) in addition to further targeted therapy (bevacizumab) plus combination chemotherapy (FOLFIRI) in people with advanced, metastatic bowel cancer who have had previous treatment.
 

This trial is treating patients with cancer of the bowel, colon or rectum.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • 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.

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 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Bevacizumab and FOLFIRI Versus Bevacizumab and FOLFIRI in Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)

Commercial Sponsor

Gilead Sciences, Inc.

Summary

This study has two parts. Part 1 (safety run-in) is evaluating how safe and tolerable, and determine the recommended Phase 2 dose (RP2D), of magrolimab + FOLFIRI. Participants in this cohort will receive magrolimab in de-escalating doses to establish the RP2D, in combination with bevacizumab (5mg/kg every 2 weeks) + FOLFIRI (irinotecan 180mg/m^2 + leucovorin 400mg/m^2 + fluorouracil 400mg/m^2 bolus followed by 2400mg/m^2 continuous on Days 1, 2, 15 and 16 of a 28-day cycle). Part 2 (randomised cohort) is further evaluating the effectiveness of this treatment. The second part has an Experimental Arm and an Active Comparator Arm. In the Experimental Arm, participants will receive the RP2D determined in the safety run-in cohort of magrolimab in combination with bevacizumab (5 mg/kg every 2 weeks) + FOLFIRI (irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous on Days 1, 2, 15, and 16 of a 28-Day Cycle). Additional dose expansion cohorts of magrolimab in combination with bevacizumab and FOLFIRI may be opened at the sponsor's discretion. In the Active Comparator Arm, participants will receive bevacizumab (5 mg/kg every 2 weeks) + FOLFIRI (irinotecan 180 mg/m^2 +leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous on Days 1, 2, 15, and 16 of a 28-Day Cycle). All treatments will be administered intravenously.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Medical Oncology
Prahran
Ms Anne Everts
a.everts@alfred.org.au
03 9076 0566

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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