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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02821013




Registration number
NCT02821013
Ethics application status
Date submitted
29/06/2016
Date registered
1/07/2016

Titles & IDs
Public title
Duration of Anti-PD-1 Therapy in Metastatic Melanoma
Scientific title
A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma
Secondary ID [1] 0 0
UQ-QMP-0001
Secondary ID [2] 0 0
ME13
Universal Trial Number (UTN)
Trial acronym
STOP-GAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable/Metastatic Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
7 years
Secondary outcome [1] 0 0
Progression-free survival using RECIST 1.1 / Immune-Related RECIST (irRECIST)
Timepoint [1] 0 0
7 years
Secondary outcome [2] 0 0
Response rate using RECIST 1.1 / Immune-Related RECIST (irRECIST)
Timepoint [2] 0 0
7 years
Secondary outcome [3] 0 0
Duration of response using RECIST 1.1 / Immune-Related RECIST (irRECIST)
Timepoint [3] 0 0
7 years
Secondary outcome [4] 0 0
Number and severity of adverse events using CTCAE v 4.0
Timepoint [4] 0 0
7 years
Secondary outcome [5] 0 0
Quality of Life measured by EORTC QLQ-C30
Timepoint [5] 0 0
7 years
Secondary outcome [6] 0 0
Economic evaluation consisting of both healthcare utilization and health utilities measured by the EQ-5D questionnaire
Timepoint [6] 0 0
7 years

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



* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
614
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
MilduraNSW,QLD,South A.VIC
Recruitment hospital [1] 0 0
Mildura Base Public Hospital - Victoria
Recruitment hospital [2] 0 0
Coffs Habour Health Campus - NCCI - Coffs Harbour
Recruitment hospital [3] 0 0
Riverina Cancer Care Centre Wagga Wagga - Wagga Wagga
Recruitment hospital [4] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [8] 0 0
Cairns Hospital - Cairns
Recruitment hospital [9] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [10] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [11] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [12] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [13] 0 0
Royal Brisbane and Womens Hospital - Herston
Recruitment postcode(s) [1] 0 0
3500 - Victoria
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4575 - Birtinya
Recruitment postcode(s) [7] 0 0
4102 - Brisbane
Recruitment postcode(s) [8] 0 0
4870 - Cairns
Recruitment postcode(s) [9] 0 0
4215 - Southport
Recruitment postcode(s) [10] 0 0
5011 - Woodville
Recruitment postcode(s) [11] 0 0
3168 - Clayton
Recruitment postcode(s) [12] 0 0
3004 - Melbourne
Recruitment postcode(s) [13] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
New Brunswick
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Canada
State/province [6] 0 0
Saskatchewan

Funding & Sponsors
Primary sponsor type
Other
Name
Canadian Cancer Trials Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Melanoma and Skin Cancer Trials Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Xinni Song
Address 0 0
Ottawa Hospital Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Janet Dancey
Address 0 0
Country 0 0
Phone 0 0
613-533-6430
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02821013