Duration of Anti-PD-1 Therapy in Metastatic Melanoma
STOP-GAP
A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma
2 other identifiers
interventional
614
2 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2016
Longer than P75 for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2016
CompletedFirst Posted
Study publicly available on registry
July 1, 2016
CompletedStudy Start
First participant enrolled
October 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
April 14, 2026
December 1, 2025
11.2 years
June 29, 2016
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
7 years
Secondary Outcomes (6)
Progression-free survival using RECIST 1.1 / Immune-Related RECIST (irRECIST)
7 years
Response rate using RECIST 1.1 / Immune-Related RECIST (irRECIST)
7 years
Duration of response using RECIST 1.1 / Immune-Related RECIST (irRECIST)
7 years
Number and severity of adverse events using CTCAE v 4.0
7 years
Quality of Life measured by EORTC QLQ-C30
7 years
- +1 more secondary outcomes
Study Arms (2)
Arm 1: Intermittent PD-1 Inhibitor therapy
ACTIVE COMPARATORAny 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 COMPARATORAny PD-1 inhibitor that is commercially available, government approved and publicly funded. Dose as recommended by the manufacturer.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Coffs Habour Health Campus - NCCI
Coffs Harbour, New South Wales, 2450, Australia
Calvary Mater Newcastle Hospital
Waratah, New South Wales, 2298, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Cairns Hospital
Cairns, Queensland, 4870, Australia
Gold Coast University Hospital
Southport, Queensland, 4215, Australia
The Queen Elizabeth Hospital
Woodville, South A., 5011, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Mildura Base Public Hospital
Mildura, Victoria, 3500, Australia
Royal Brisbane and Womens Hospital
Herston, 4029, Australia
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
BCCA - Surrey
Surrey, British Columbia, V3V 1Z2, Canada
BCCA - Vancouver
Vancouver, British Columbia, V5Z 4E6, Canada
BCCA - Victoria
Victoria, British Columbia, V8R 6V5, Canada
Horizon Health Network
Fredericton, New Brunswick, E3B 5N5, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
Health Sciences North
Greater Sudbury, Ontario, P3E 5J1, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
Waterloo Regional Health Network (WRHN)
Kitchener, Ontario, N2G 1G3, Canada
London Health Sciences Centre Research Inc.
London, Ontario, N6A 5W9, Canada
Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario, L5M 2N1, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6, Canada
Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network
Toronto, Ontario, M5G 2M9, Canada
The Research Institute of the McGill University
Montreal, Quebec, H4A 3J1, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xinni Song
Ottawa Hospital Research Institute
- STUDY CHAIR
Tara Baetz
Cancer Centre of Southeastern Ontario at Kingston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2016
First Posted
July 1, 2016
Study Start
October 31, 2016
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2029
Last Updated
April 14, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share