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NCT04854499 : A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Head and Neck<br/>CancersCancer LocationHead and Neck
Cancers

Systemic therapy,Treatment | Head and neckHead and neck

Trial Overview Read MoreRead more

This phase II study is assessing how safe and effective different combinations of immunotherapy (magrolimab, pembrolizumab, and zimberelimab) is, with or without chemotherapy (5-FU + platinum chemotherapy, or docetaxel) in people with head and neck squamous cell carcinoma .
 

This trial is treating patients with head and neck squamous cell carcinoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • 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 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

Commercial Sponsor

Gilead Sciences, Inc.

Summary

This study consists of a Safety Run-in and Phase 2 Cohorts. The primary objective of the safety run-in cohorts are to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of magrolimab in combination with pembrolizumab + 5-fluorouracil (5-FU) + platinum chemotherapy, and docetaxel in combination with magrolimab. In Safety Run-in Cohort 1, participants will receive magrolimab + pembrolizumab + 5-FU + platinum chemotherapy, all administered intravenously. In Safety Run-in Cohort 2, participants will receive magrolimab + docetaxel, both administered intravenously. In the Pre-expansion Safety Run-in Cohort, participants will receive magrolimab + pembrolizumab, both administered intravenously. The objective of the Phase 2 cohorts are to evaluate the effectiveness of these treatments. In the Phase 2 Cohort 1 (Arm A), participants will receive magrolimab + pembrolizumab + 5-FU + platinum chemotherapy, all administered intravenously. In the Phase 2 Cohort 1 (Arm B), participants will receive pembrolizumab + 5-FU + platinum chemotherapy. In the Phase 2 Cohort 1 (Arm C), participants will receive magrolimab + zimberelimab + 5-FU + platinum chemotherapy. In the Phase 2 Cohort 2, participants will receive magrolimab + pembrolizumab. In the Phase 2 Cohort 3, participants will receive magrolimab + docetaxel.

Recruiting Hospitals Read MoreRead more

Austin Health
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

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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