Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
614 participants
INTERVENTIONAL
2016-10-31
2029-12-31
Brief Summary
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Detailed Description
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To-date, PD-1 inhibitors have been given to patients with melanoma continuously (non-stop), for as long as they remain beneficial, for up to a total duration of 2 years. The 2 year duration was chosen because doctors thought it was reasonable, and has been adopted as the standard or usual duration because it was shown to work in clinical trials. However, some recent observations suggest that PD-1 inhibitors may work just as well if they are given for a shorter time and/or in an intermittent schedule. Intermittent means to take breaks from receiving the drug when, and for as long as, the melanoma is better.
The investigators doing this study are interested to find out whether patients with melanoma live as long when the PD-1 inhibitors are given continuously (non-stop) or in an intermittent schedule (taking breaks). If the two ways of giving the treatment were to be shown to be just as good, benefits of an intermittent schedule may include less clinic visits and side effects, better quality of life, and less cost over time for the Health Care System. However, this is not known at present.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: Intermittent PD-1 Inhibitor therapy
Any PD-1 inhibitor that is commercially available, government approved and publicly funded. Dose as recommended by the manufacturer.
Intermittent PD-1 inhibitor therapy
Arm 2: Continuous PD-1 Inhibitor therapy
Any PD-1 inhibitor that is commercially available, government approved and publicly funded. Dose as recommended by the manufacturer.
Continuous PD-1 inhibitor therapy
Interventions
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Continuous PD-1 inhibitor therapy
Intermittent PD-1 inhibitor therapy
Eligibility Criteria
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Inclusion Criteria
* Eligible to receive treatment with a government approved and publically-funded PD-1 inhibitor, according to the guidance / indications described in the Product Monograph / Provincial Formulary.
* Patients must have evidence of unresectable / metastatic disease, that is considered evaluable by the investigator and can be followed, but measurable disease is not mandatory.
* Patients with brain metastases are allowed, provided they are stable according to the following definitions:
1. Without evidence of progression for at least four weeks prior to randomization and have no evidence of new or enlarging brain metastases.
2. Treated with surgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases.
3. Treated with stereotactic radiosurgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases.
* Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and health utility questionnaires in either English or French. The baseline assessment must be completed within required timelines, prior to randomization. Inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
* Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
* Patients must be randomized prior to the start of, or within 16 weeks from, the initiation of PD-1 inhibitor treatment. For patients who are being randomized before the start of treatment, the PD-1 inhibitor should be started within 5 working days after randomization. Patients who initiate treatment with combination anti-PD-1 and anti-CTLA-4 therapies who experience toxicity may be randomized at the time prior to starting single-agent PD-1 inhibitor. Repeat imaging must be done within 50 days prior to randomization to ensure the patient has no evidence of disease progression
Exclusion Criteria
* Patients with any contraindications to PD-1 inhibitors, as described in the Product Monograph or Provincial Formulary, and/or not eligible to receive anti-PD-1 therapy.
18 Years
ALL
No
Sponsors
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Melanoma and Skin Cancer Trials Limited
OTHER
Canadian Cancer Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Xinni Song
Role: STUDY_CHAIR
Ottawa Hospital Research Institute
Tara Baetz
Role: STUDY_CHAIR
Cancer Centre of Southeastern Ontario at Kingston
Locations
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Mildura Base Public Hospital
Victoria, Mildura, Australia
Coffs Habour Health Campus - NCCI
Coffs Harbour, New South Wales, Australia
Riverina Cancer Care Centre Wagga Wagga
Wagga Wagga, 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
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
Countries
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Central Contacts
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Facility Contacts
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Jose Leal
Role: primary
Karen Briscoe
Role: primary
Renuka Chittajallu
Role: primary
Ina Nordman
Role: primary
Matteo Carlino
Role: primary
Mary Wagih Azer
Role: primary
Megan Lyle
Role: primary
Marcin Dzienis
Role: primary
Rachel Roberts-thomson
Role: primary
Muhammad Alamgeer
Role: primary
Mark Shackleton
Role: primary
Melissa Eastgate
Role: primary
John Walker
Role: primary
Christopher Lee
Role: primary
Kerry J. Savage
Role: primary
Tara Baetz
Role: primary
M. Saleem Raza
Role: primary
Jason Yu
Role: primary
Lacey Pitre
Role: primary
Elaine McWhirter
Role: primary
Mihaela Mates
Role: primary
Gregory J. Knight
Role: primary
John Lenehan
Role: primary
Sudha Rajagopal
Role: primary
Rama Koneru
Role: primary
Xinni Song
Role: primary
Teresa M. Petrella
Role: primary
Marcus Butler
Role: primary
Catalin Mihalcioiu
Role: primary
Mussawar Iqbal
Role: primary
Tahir Abbas
Role: primary
Other Identifiers
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UQ-QMP-0001
Identifier Type: OTHER
Identifier Source: secondary_id
ME13
Identifier Type: -
Identifier Source: org_study_id