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ANZMTG 01.17 STOP GAP Trial - Canadian Collaborative Group Protocol: STOP-GAP - A randomised phase III study of duration of anti-PD1 therapy in metastatic melanoma; this proposal is for a parallel sister protocol running in ANZ

Immunotherapies, in particular anti-PD-1 therapies, are now standard of care for patients with metastatic melanoma. Currently, trials involving anti-PD-1 therapies allow for indefinite treatment in the absence of toxicity or progression, or have built in stopping rules such as investigator’s choice, or at 24 months of treatment. However, physicians do not know what the optimal anti-PD-1 treatment duration is, and genuine uncertainty exists

STOP-GAP, an international, investigator-led, multicentre, randomised phase III trial, will be the first prospective trial to investigate interrupted versus continuous anti-PD-1 treatment for patients with metastatic melanoma.   
 
Study Status: In Development
ANZ Clinical Trials Registry Number: In Progress
ClinicalTrials.gov Identifier - NCT02821013
 
Study Chair:
A/Prof Victoria Atkinson
Princess Alexandra Hospital 
Phone: +61 2 9911 7386 
 
Documents (PDF downloads):
  • Trial Synopsis
  • Trial Protocol
  • Case Report Forms
  • Case Report Forms Completion Guidelines
  • Operations Manual
  • Trial Publications and Presentations
  • Site Contacts


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