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Can taking drug breaks work as well as continuous treatment for melanoma?

NCT ID NCT02821013

Disease control Sponsor: Canadian Cancer Trials Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether taking a standard immunotherapy drug (PD-1 inhibitor) on an intermittent schedule works as well as taking it continuously for people with advanced melanoma that cannot be removed by surgery. About 614 participants will be randomly assigned to one of the two schedules. The main goal is to see if overall survival is similar between the groups, while also checking side effects and quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 614 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2016

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Unresectable/metastatic melanoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Allan Blair Cancer Centre

    RECRUITING

    Regina, Saskatchewan, S4T 7T1, Canada

  • BCCA - Surrey

    RECRUITING

    Surrey, British Columbia, V3V 1Z2, Canada

  • BCCA - Vancouver

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • BCCA - Victoria

    RECRUITING

    Victoria, British Columbia, V8R 6V5, Canada

  • Cairns Hospital

    RECRUITING

    Cairns, Queensland, 4870, Australia

  • Calvary Mater Newcastle Hospital

    RECRUITING

    Waratah, New South Wales, 2298, Australia

  • Coffs Habour Health Campus - NCCI

    RECRUITING

    Coffs Harbour, New South Wales, 2450, Australia

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Gold Coast University Hospital

    RECRUITING

    Southport, Queensland, 4215, Australia

  • Health Sciences North

    RECRUITING

    Greater Sudbury, Ontario, P3E 5J1, Canada

  • Horizon Health Network

    RECRUITING

    Fredericton, New Brunswick, E3B 5N5, Canada

  • Juravinski Cancer Centre at Hamilton Health Sciences

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • Kingston Health Sciences Centre

    RECRUITING

    Kingston, Ontario, K7L 2V7, Canada

  • Lakeridge Health Oshawa

    RECRUITING

    Oshawa, Ontario, L1G 2B9, Canada

  • London Health Sciences Centre Research Inc.

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Mildura Base Public Hospital

    RECRUITING

    Victoria, Mildura, 3500, Australia

  • Monash Medical Centre

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Odette Cancer Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Ottawa Hospital Research Institute

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • Royal Brisbane and Womens Hospital

    RECRUITING

    Herston, 4029, Australia

  • Royal Victoria Regional Health Centre

    RECRUITING

    Barrie, Ontario, L4M 6M2, Canada

  • Saskatoon Cancer Centre

    RECRUITING

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • Sunshine Coast University Hospital

    RECRUITING

    Birtinya, Queensland, 4575, Australia

  • The Queen Elizabeth Hospital

    RECRUITING

    Woodville, South A., 5011, Australia

  • The Research Institute of the McGill University

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Trillium Health Partners - Credit Valley Hospital

    RECRUITING

    Mississauga, Ontario, L5M 2N1, Canada

  • University Health Network

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Waterloo Regional Health Network (WRHN)

    RECRUITING

    Kitchener, Ontario, N2G 1G3, Canada

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia