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.

NCT04674683 : A Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined With Nivolumab Versus Placebo With Nivolumab in Patients With Unresectable or Metastatic Melanoma Not Previously Treated With PD-1 or PD-L1 Inhibitors

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

12+Age Over 12

Skin<br/>CancersCancer LocationSkin
Cancers

Systemic therapy | SkinMelanoma (Skin)

Trial Overview Read MoreRead more

This Phase III trial is trying to understand how effective a new anti-cancer drug (HBI-8000) is in combination with immunotherapy (Nivolumab) in people with advanced melanoma.
 

This trial is treating patients with melanoma.

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 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

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

Scientific Title

A Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined With Nivolumab Versus Placebo With Nivolumab in Patients With Unresectable or Metastatic Melanoma Not Previously Treated With PD-1 or PD-L1 Inhibitors

Commercial Sponsor

HUYA Bioscience International

Summary

This is a multicentre, randomised, double-blind, placebo-controlled trial with Experimental and Placebo Comparator arms. All Eligible patients will be randomized to either the Experimental or Placebo Comparator arm at a 1:1 ratio. Study treatment will be initiated within 3 days of randomization. In both arms of the trial, treatment cycles consist of 28 days.

Recruiting Hospitals Read MoreRead more

Ballarat Hospital
Ballarat
Ms Carmel Goss
CarmelG@bhs.org.au
03 5320 4735

Goulburn Valley Health
Shepparton
Ms Carole Mott
oncologyclinicaltrials@gvhealth.org.au
(03) 5832 3777

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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