Recruiting
Phase 3

Anti-PD-1 Therapy

Sponsor:

Canadian Cancer Trials Group

Code:

NCT02821013

Conditions

Unresectable/Metastatic Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intermittent PD-1 inhibitor therapy

Continuous PD-1 inhibitor therapy

Study Details

Brief 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.

Conditions

Unresectable/Metastatic Melanoma

Study ID

NCT02821013

Start date

Oct 31, 2016

Status verified date

Dec, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Minimum age 18 or as specified in the Product Monograph and eligible for public funding.

Inclusion Criteria:

  • 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:

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 not willing to stop anti-PD-1 therapy, if randomized to the intermittent arm.
  • 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.

Study Design

Enrollment

614 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Intermittent PD-1 inhibitor therapy

Continuous PD-1 inhibitor therapy

Primary outcome measure

  • Overall survival [ Time Frame: 7 years ]

Central Contacts and Locations

Central contacts

Janet Dancey

613-533-6430jdancey@ctg.queensu.ca

Locations

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Contacts

John Walker

780 432-8340

BCCA - Surrey

Recruiting

Surrey, British Columbia, Canada, V3V 1Z2

Contacts

Christopher Lee

604 930-4017

BCCA - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Kerry J. Savage

604 877-6000

BCCA - Victoria

Recruiting

Victoria, British Columbia, Canada, V8R 6V5

Horizon Health Network

Recruiting

Fredericton, New Brunswick, Canada, E3B 5N5

Contacts

M. Saleem Raza

506 447-4095

Royal Victoria Regional Health Centre

Recruiting

Barrie, Ontario, Canada, L4M 6M2

Contacts

Jason Yu

705 728-9090

Health Sciences North

Recruiting

Greater Sudbury, Ontario, Canada, P3E 5J1

Contacts

Lacey Pitre

705 522-6237

Juravinski Cancer Centre at Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

Elaine McWhirter

905 387-9495

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Mihaela Mates

613 549-2631

Waterloo Regional Health Network (WRHN)

Recruiting

Kitchener, Ontario, Canada, N2G 1G3

Contacts

Gregory J. Knight

519 749-4370

London Health Sciences Centre Research Inc.

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

John Lenehan

519 685-8640

Trillium Health Partners - Credit Valley Hospital

Recruiting

Mississauga, Ontario, Canada, L5M 2N1

Contacts

Sudha Rajagopal

905 813-1100

Lakeridge Health Oshawa

Recruiting

Oshawa, Ontario, Canada, L1G 2B9

Contacts

Rama Koneru

905 576-8711

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Xinni Song

613 737-7700

Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Teresa M. Petrella

416 480-5145

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Marcus Butler

416 946-4501

The Research Institute of the McGill University

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Catalin Mihalcioiu

514 934-1934

Allan Blair Cancer Centre

Recruiting

Regina, Saskatchewan, Canada, S4T 7T1

Contacts

Mussawar Iqbal

306 766-2691

Saskatoon Cancer Centre

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 4H4

Contacts

Tahir Abbas

306 655-2710

More Information

Sponsor

Canadian Cancer Trials Group

Last update posted

Jun 9, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Cancer Trials Group on 2026-06-09.