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

Who is this study for? Patients with Unresectable/Metastatic Melanoma
What treatments are being studied? PD-1 Inhibitor Therapy
Status: Recruiting
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed melanoma that is unresectable / metastatic (stage III or stage IV).

• 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:

‣ Without evidence of progression for at least four weeks prior to randomization and have no evidence of new or enlarging brain metastases.

⁃ Treated with surgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases.

⁃ 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

Locations
Other Locations
Australia
Sunshine Coast University Hospital
RECRUITING
Birtinya
Cairns Hospital
RECRUITING
Cairns
Monash Medical Centre
RECRUITING
Clayton
Coffs Habour Health Campus - NCCI
RECRUITING
Coffs Harbour
Royal Brisbane and Womens Hospital
RECRUITING
Herston
Alfred Hospital
RECRUITING
Melbourne
Gold Coast University Hospital
RECRUITING
Southport
Mildura Base Public Hospital
RECRUITING
Victoria
Riverina Cancer Care Centre Wagga Wagga
NOT_YET_RECRUITING
Wagga Wagga
Calvary Mater Newcastle Hospital
RECRUITING
Waratah
Westmead Hospital
RECRUITING
Westmead
The Queen Elizabeth Hospital
RECRUITING
Woodville
Canada
Royal Victoria Regional Health Centre
RECRUITING
Barrie
Cross Cancer Institute
RECRUITING
Edmonton
Horizon Health Network
RECRUITING
Fredericton
Health Sciences North
RECRUITING
Greater Sudbury
Juravinski Cancer Centre at Hamilton Health Sciences
RECRUITING
Hamilton
Kingston Health Sciences Centre
RECRUITING
Kingston
Waterloo Regional Health Network (WRHN)
RECRUITING
Kitchener
London Health Sciences Centre Research Inc.
RECRUITING
London
Trillium Health Partners - Credit Valley Hospital
RECRUITING
Mississauga
The Research Institute of the McGill University
RECRUITING
Montreal
Lakeridge Health Oshawa
RECRUITING
Oshawa
Ottawa Hospital Research Institute
RECRUITING
Ottawa
Allan Blair Cancer Centre
RECRUITING
Regina
Saskatoon Cancer Centre
RECRUITING
Saskatoon
BCCA - Surrey
RECRUITING
Surrey
Odette Cancer Centre
RECRUITING
Toronto
University Health Network
RECRUITING
Toronto
BCCA - Vancouver
RECRUITING
Vancouver
BCCA - Victoria
RECRUITING
Victoria
Contact Information
Primary
Janet Dancey
jdancey@ctg.queensu.ca
613-533-6430
Time Frame
Start Date: 2016-10-31
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 614
Treatments
Active_comparator: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Melanoma and Skin Cancer Trials Limited
Leads: Canadian Cancer Trials Group

This content was sourced from clinicaltrials.gov