RecruitingPhase 3NCT02821013

Duration of Anti-PD-1 Therapy in Metastatic Melanoma

A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma

Sponsor

Canadian Cancer Trials Group

Enrollment

614 participants

Start Date

Oct 31, 2016

Study Type

INTERVENTIONAL

Conditions

Unresectable/Metastatic Melanoma

Summary

The purpose of this study is to compare the effects on patients with metastatic melanoma of taking a government approved and paid-for PD-1 inhibitor intermittently, with taking the same type of agent continuously. Researchers want to see if the two ways of giving this type of treatment work equally well in extending the life of patients with melanoma, or not.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how long patients with advanced melanoma — a serious skin cancer that has spread to other parts of the body — should continue receiving a type of immunotherapy drug called a PD-1 inhibitor, which works by helping the immune system attack cancer cells. **You may be eligible if...** - You are 18 years or older - You have been confirmed by biopsy to have melanoma that cannot be surgically removed or has spread to other organs (stage III or IV) - You qualify to receive a government-funded PD-1 inhibitor drug based on your provincial guidelines - Your cancer can be monitored by your doctor, even if it is not strictly measurable by standard criteria - If your cancer has spread to the brain, those spots must have been stable for at least 4 weeks **You may NOT be eligible if...** - You do not qualify for publicly funded PD-1 inhibitor therapy - Your brain metastases are active or unstable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntermittent PD-1 inhibitor therapy

DRUGContinuous PD-1 inhibitor therapy

Locations(30)

Coffs Habour Health Campus - NCCI

Coffs Harbour, New South Wales, Australia

Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Cairns Hospital

Cairns, Queensland, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

The Queen Elizabeth Hospital

Woodville, South A., Australia

Monash Medical Centre

Clayton, Victoria, Australia

Alfred Hospital

Melbourne, Victoria, Australia

Mildura Base Public Hospital

Mildura, Victoria, Australia

Royal Brisbane and Womens Hospital

Herston, Australia

Cross Cancer Institute

Edmonton, Alberta, Canada

BCCA - Surrey

Surrey, British Columbia, Canada

BCCA - Vancouver

Vancouver, British Columbia, Canada

BCCA - Victoria

Victoria, British Columbia, Canada

Horizon Health Network

Fredericton, New Brunswick, Canada

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Health Sciences North

Greater Sudbury, Ontario, Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Waterloo Regional Health Network (WRHN)

Kitchener, Ontario, Canada

London Health Sciences Centre Research Inc.

London, Ontario, Canada

Trillium Health Partners - Credit Valley Hospital

Mississauga, Ontario, Canada

Lakeridge Health Oshawa

Oshawa, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Odette Cancer Centre

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

The Research Institute of the McGill University

Montreal, Quebec, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT02821013