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Duration of Anti-PD-1 Therapy in Metastatic Melanoma

PHASE3RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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. 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

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2016-10-31

Primary completion: 2027-12-31

Study completion finish: 2029-12-31

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT02821013

Intervention or treatment

DRUG: Intermittent PD-1 inhibitor therapy

DRUG: Continuous PD-1 inhibitor therapy

Conditions

• Unresectable/Metastatic Melanoma

Image related to Unresectable/Metastatic Melanoma

Condition: Unresectable/Metastatic Melanoma
DRUG: Intermittent PD-1 inhibitor therapy and other drugs
Waratah, New South Wales, Australia and more
Sponsor: Canadian Cancer Trials Group

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Calvary Mater Newcastle Hospital

Research sites nearby

Select from list below to view details:

Calvary Mater Newcastle Hospital
Waratah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/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.	DRUG: Intermittent PD-1 inhibitor therapy Not Specified
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.	DRUG: Continuous PD-1 inhibitor therapy Not Specified

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Overall survival	Not Specified	7 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Progression-free survival using RECIST 1.1 / Immune-Related RECIST (irRECIST)	Not Specified	7 years
Response rate using RECIST 1.1 / Immune-Related RECIST (irRECIST)	Not Specified	7 years
Duration of response using RECIST 1.1 / Immune-Related RECIST (irRECIST)	Not Specified	7 years
Number and severity of adverse events using CTCAE v 4.0	Not Specified	7 years
Quality of Life measured by EORTC QLQ-C30	Not Specified	7 years
Economic evaluation consisting of both healthcare utilization and health utilities measured by the EQ-5D questionnaire	Not Specified	7 years

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: Duration of Anti-PD-1 Therapy in Metastatic Melanoma