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Duration of Anti-PD-1 Therapy in Metastatic Melanoma (STOP-GAP)

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ClinicalTrials.gov Identifier: NCT02821013
Recruitment Status : Recruiting
First Posted : July 1, 2016
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
Australia and New Zealand Melanoma Trials Group
Information provided by (Responsible Party):
Canadian Cancer Trials Group

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.

Condition or disease Intervention/treatment Phase
Unresectable/Metastatic Melanoma Other: Intermittent PD-1 inhibitor therapy Other: Continuous PD-1 inhibitor therapy Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 614 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma (STOP-GAP)
Study Start Date : July 4, 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
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.
Other: Intermittent PD-1 inhibitor therapy
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.
Other: Continuous PD-1 inhibitor therapy



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 7 years ]

Secondary Outcome Measures :
  1. Progression-free survival using RECIST 1.1 / Immune-Related RECIST (irRECIST) [ Time Frame: 7 years ]
  2. Response rate using RECIST 1.1 / Immune-Related RECIST (irRECIST) [ Time Frame: 7 years ]
  3. Duration of response using RECIST 1.1 / Immune-Related RECIST (irRECIST) [ Time Frame: 7 years ]
  4. Number and severity of adverse events using CTCAE v 4.0 [ Time Frame: 7 years ]
  5. Quality of Life measured by EORTC QLQ-C30 [ Time Frame: 7 years ]
  6. Economic evaluation consisting of both healthcare utilization and health utilities measured by the EQ-5D questionnaire [ Time Frame: 7 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821013


Contacts
Contact: Janet Dancey 613-533-6430 jdancey@ctg.queensu.ca

Locations
Australia, Queensland
Princess Alexandria Hospital Not yet recruiting
Brisbane, Queensland, Australia
Contact: Victoria Atkinson         
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: John Walker    780 432-8340      
Canada, British Columbia
BCCA - Fraser Valley Cancer Centre Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Contact: Christopher Lee    604 930-4017      
BCCA - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Kerry J. Savage    604 877-6000 ext 2641      
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Ralph P.W. Wong    204 235-3044      
Canada, New Brunswick
Horizon Health Network Recruiting
Fredericton, New Brunswick, Canada, E3B 5N5
Contact: M. Saleem Raza    506 447-4095      
Canada, Ontario
Royal Victoria Regional Health Centre Recruiting
Barrie, Ontario, Canada, L4M 6M2
Contact: Jason Yu    705 728-9090      
Juravinski Cancer Centre at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Elaine McWhirter    905 387-9495 ext 64609      
Kingston Health Sciences Centre Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Tara Baetz    613 544-2630      
Grand River Regional Cancer Centre Recruiting
Kitchener, Ontario, Canada, N2G 1G3
Contact: Gregory J. Knight    519 749-4370 ext 5262      
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 5W9
Contact: John Lenehan    519 685-8640      
Trillium Health Partners - Credit Valley Hospital Recruiting
Mississauga, Ontario, Canada, L5M 2N1
Contact: Sudha Rajagopal    905 813-1100 ext 5135      
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Xinni Song    613 737-7700 ext 70208      
Health Sciences North Recruiting
Sudbury, Ontario, Canada, P3E 5J1
Contact: Lacey Pitre    705 522-6237      
Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Teresa M. Petrella    416 480-4662      
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Marcus Butler    416 946-4501 ext 5485      
Canada, Quebec
The Research Institute of the McGill University Not yet recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Catalin Mihalcioiu    514 934-1934      
Canada, Saskatchewan
Allan Blair Cancer Centre Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Mussawar Iqbal    306 766-2691      
Saskatoon Cancer Centre Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Tahir Abbas    306 655-2710      
Sponsors and Collaborators
Canadian Cancer Trials Group
Australia and New Zealand Melanoma Trials Group
Investigators
Study Chair: Xinni Song Ottawa Hospital Research Institute
Study Chair: Tara Baetz Cancer Centre of Southeastern Ontario at Kingston

Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT02821013     History of Changes
Other Study ID Numbers: ME13
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas