Unresectable/Metastatic MelanomaPhase 3STOP-GAPNCT02821013
Duration of Anti-PD-1 Therapy in Metastatic Melanoma
A Phase 3 study testing Intermittent PD-1 inhibitor therapy and Continuous PD-1 inhibitor therapy in people with Unresectable/Metastatic Melanoma, run by Canadian Cancer Trials Group at 30 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable/Metastatic Melanoma
- What is being tested?
- Intermittent PD-1 inhibitor therapy and Continuous PD-1 inhibitor therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 30 sitesin 2 countries
- Study dates
- 31 Oct 2016to 31 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
30 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
30 sites in 2 countries
Canada19 sites, 19 recruiting
- Recruiting
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2
Jason Yu, 705 728-9090
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
John Walker, 780 432-8340
- Recruiting
Horizon Health Network
Fredericton, New Brunswick, E3B 5N5
M. Saleem Raza, 506 447-4095
- Recruiting
Health Sciences North
Greater Sudbury, Ontario, P3E 5J1
Lacey Pitre, 705 522-6237
- Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
Elaine McWhirter, 905 387-9495 ext. 64609
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Mihaela Mates, 613 549-2631 ext. 77725
- Recruiting
Waterloo Regional Health Network (WRHN)
Kitchener, Ontario, N2G 1G3
Gregory J. Knight, 519 749-4370 ext. 5262
- Recruiting
London Health Sciences Centre Research Inc.
London, Ontario, N6A 5W9
John Lenehan, 519 685-8640
- Recruiting
Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Sudha Rajagopal, 905 813-1100 ext. 5135
- Recruiting
The Research Institute of the McGill University
Montreal, Quebec, H4A 3J1
Catalin Mihalcioiu, 514 934-1934
- Recruiting
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Rama Koneru, 905 576-8711
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Xinni Song, 613 737-7700 ext. 70208
- Recruiting
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Mussawar Iqbal, 306 766-2691
- Recruiting
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Tahir Abbas, 306 655-2710
- Recruiting
BCCA - Surrey
Surrey, British Columbia, V3V 1Z2
Christopher Lee, 604 930-4017
- Recruiting
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Teresa M. Petrella, 416 480-5145
- Recruiting
University Health Network
Toronto, Ontario, M5G 2M9
Marcus Butler, 416 946-4501 ext. 5485
- Recruiting
BCCA - Vancouver
Vancouver, British Columbia, V5Z 4E6
Kerry J. Savage, 604 877-6000 ext. 2641
- Recruiting
BCCA - Victoria
Victoria, British Columbia, V8R 6V5
Tara Baetz
Australia11 sites, 11 recruiting
- Recruiting
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
Mary Wagih Azer, 7 520-0200 ext. 651
- Recruiting
Cairns Hospital
Cairns, Queensland, 4870
Megan Lyle
- Recruiting
Monash Medical Centre
Clayton, Victoria, 3168
Muhammad Alamgeer
- Recruiting
Coffs Habour Health Campus - NCCI
Coffs Harbour, New South Wales, 2450
Karen Briscoe
- Recruiting
Royal Brisbane and Womens Hospital
Herston, 4029
Melissa Eastgate
- Recruiting
Alfred Hospital
Melbourne, Victoria, 3004
Mark Shackleton
- Recruiting
Gold Coast University Hospital
Southport, Queensland, 4215
Marcin Dzienis
- Recruiting
Mildura Base Public Hospital
Victoria, Mildura, 3500
Jose Leal
- Recruiting
Calvary Mater Newcastle Hospital
Waratah, New South Wales, 2298
Ina Nordman
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Matteo Carlino
- Recruiting
The Queen Elizabeth Hospital
Woodville, South A., 5011
Rachel Roberts-thomson
About this study
Official title: A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma
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.
Read the detailed description
The standard or usual treatment for this disease is to receive treatment with a class of agents known as PD-1 inhibitors, or also with the names anti-PD-1 therapy, immunotherapy and checkpoint inhibitors. PD-1 inhibitors turn on the immune system, so that it can fight the cancer cells in the body. Clinical trials have shown that PD-1 inhibitors (such as pembrolizumab and nivolumab) can shrink tumours and extend the life of patients with melanoma.
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
- Unresectable/Metastatic Melanoma
- Being tested
- Intermittent PD-1 inhibitor therapy, Continuous PD-1 inhibitor therapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent PD-1 inhibitor therapyDrug
Continuous PD-1 inhibitor therapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Intermittent PD-1 Inhibitor therapy | Active comparator | Any PD-1 inhibitor that is commercially available, government approved and publicly funded. Dose as recommended by the manufacturer. Receives: Drug: Intermittent PD-1 inhibitor therapy |
| Arm 2: Continuous PD-1 Inhibitor therapy | Active comparator | Any PD-1 inhibitor that is commercially available, government approved and publicly funded. Dose as recommended by the manufacturer. Receives: Drug: Continuous PD-1 inhibitor therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 7 years
Secondary outcomes (6)
Progression-free survival using RECIST 1.1 / Immune-Related RECIST (irRECIST)
Measured: 7 years
Response rate using RECIST 1.1 / Immune-Related RECIST (irRECIST)
Measured: 7 years
Duration of response using RECIST 1.1 / Immune-Related RECIST (irRECIST)
Measured: 7 years
Number and severity of adverse events using CTCAE v 4.0
Measured: 7 years
Quality of Life measured by EORTC QLQ-C30
Measured: 7 years
Economic evaluation consisting of both healthcare utilization and health utilities measured by the EQ-5D questionnaire
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study start31 Oct 2016
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable/Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 614 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- Melanoma and Skin Cancer Trials Limited
- Responsible party
- Sponsor
- Investigators
- Xinni Song, Study chair, Ottawa Hospital Research InstituteTara Baetz, Study chair, Cancer Centre of Southeastern Ontario at Kingston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821013
- Sponsor's protocol ID
- ME13
- Other IDs
- UQ-QMP-0001
- Acronym
- STOP-GAP
- Status last verified
- Dec 2025
- First submitted
- 29 Jun 2016
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT02821013
- Acronym / sponsor ID
- STOP-GAP / ME13
- Conditions
- Unresectable/Metastatic Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 614 participants (estimated)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Collaborators
- Melanoma and Skin Cancer Trials Limited
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The standard or usual treatment for this disease is to receive treatment with a class of agents known as PD-1 inhibitors, or also with the names anti-PD-1 therapy, immunotherapy and checkpoint inhibitors. PD-1 inhibitors turn on the immune system, so that it can fight the cancer cells in the body. Clinical trials have shown that PD-1 inhibitors (such as pembrolizumab and nivolumab) can shrink tumours and extend the life of patients with melanoma.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Intermittent PD-1 Inhibitor therapy | Active comparator | Drug: Intermittent PD-1 inhibitor therapyAny PD-1 inhibitor that is commercially available, government approved and publicly funded. Dose as recommended by the manufacturer. |
| Arm 2: Continuous PD-1 Inhibitor therapy | Active comparator | Drug: Continuous PD-1 inhibitor therapyAny PD-1 inhibitor that is commercially available, government approved and publicly funded. Dose as recommended by the manufacturer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent PD-1 inhibitor therapy | Drug | Arm 1: Intermittent PD-1 Inhibitor therapy |
| Continuous PD-1 inhibitor therapy | Drug | Arm 2: Continuous PD-1 Inhibitor therapy |
Primary outcome
Overall survival
Time frame: 7 years
6 secondary outcomes
Progression-free survival using RECIST 1.1 / Immune-Related RECIST (irRECIST)
Time frame: 7 years
Response rate using RECIST 1.1 / Immune-Related RECIST (irRECIST)
Time frame: 7 years
Duration of response using RECIST 1.1 / Immune-Related RECIST (irRECIST)
Time frame: 7 years
Number and severity of adverse events using CTCAE v 4.0
Time frame: 7 years
Quality of Life measured by EORTC QLQ-C30
Time frame: 7 years
Economic evaluation consisting of both healthcare utilization and health utilities measured by the EQ-5D questionnaire
Time frame: 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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A Study of ST-1898 for Unresectable or Metastatic Melanoma
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BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
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A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal or Acral Melanoma Who Had Not Previously Received Systemic Therapy
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A Beta-only IL-2 ImmunoTherapY Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xinni Song study chair
Ottawa Hospital Research Institute
Tara Baetz study chair
Cancer Centre of Southeastern Ontario at Kingston
30 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intermittent PD-1 inhibitor therapy and Continuous PD-1 inhibitor therapy in people with Unresectable/Metastatic Melanoma, run by Canadian Cancer Trials Group at 30 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janet Dancey (613-533-6430, jdancey@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.