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New treatment option for Unresectable/Metastatic Melanoma
Official title Duration of Anti-PD-1 Therapy in Metastatic Melanoma
ClinicalTrials.gov ID: NCT02821013
What this study is testing
What is Intermittent PD-1 inhibitor therapy?
Intermittent PD-1 inhibitor therapy is an investigational medicine, being studied as a potential treatment for unresectable/metastatic melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patients must have evidence of unresectable / metastatic disease, that is considered evaluable by the investigator and can be followed, but...
- Patients with brain metastases are allowed, provided they are stable according to the following definitions:
You likely can't join if
- Patients not willing to stop anti-PD-1 therapy, if assigned by chance 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...
See the full eligibility 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:
- 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...
- 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...
- Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients assigned by chance on this trial will be available for complete documentation of the treatment, adverse events...
- Patients must be assigned by chance prior to the start of, or within 16 weeks from, the initiation of PD-1 inhibitor treatment. For patients who are being assigned by chance before the start of treatment, the PD-1...
- Patients not willing to stop anti-PD-1 therapy, if assigned by chance 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.
The study team makes the final eligibility decision.
Where it's taking place
- Victoria, Mildura, Australia
- Coffs Harbour, New South Wales, Australia
- Waratah, New South Wales, Australia
- Westmead, New South Wales, Australia
- Birtinya, Queensland, Australia
- Cairns, Queensland, Australia
- Southport, Queensland, Australia
- Woodville, South A., Australia
- Clayton, Victoria, Australia
- Melbourne, Victoria, Australia
- Herston, Australia
- Edmonton, Alberta, Canada
- Surrey, British Columbia, Canada
- Vancouver, British Columbia, Canada
- Victoria, British Columbia, Canada
- Fredericton, New Brunswick, Canada
- Barrie, Ontario, Canada
- Greater Sudbury, Ontario, Canada
- Hamilton, Ontario, Canada
- Kingston, Ontario, Canada
+ 9 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Victoria, Mildura, Australia; Coffs Harbour, New South Wales, Australia; Waratah, New South Wales, Australia; Westmead, New South Wales, Australia; Birtinya, Queensland, Australia; Cairns, Queensland, Australia and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.