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

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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

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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