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Duration of Anti-PD-1 Therapy in Metastatic Melanoma

ConditionUnresectable/Metastatic Melanoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Without evidence of progression for at least four weeks prior to randomization and have no evidence of new or enlarging brain metastases.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intermittent PD-1 inhibitor therapy

    Drug

  • Continuous PD-1 inhibitor therapy

    Drug

Treatment groups

614 Participants
are divided into 2 treatment groups
Group A: Arm 1: Intermittent PD-1 Inhibitor therapyActive comparator 1 intervention
Group B: Arm 2: Continuous PD-1 Inhibitor therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

Time frame
7 years

Secondary outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Canadian Cancer Trials Group

Lead sponsor

Melanoma and Skin Cancer Trials Limited

Collaborator

Source ClinicalTrials.gov
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