CHARLI : A Phase Ib/II Trial of Ipilimumab-Nivolumab-Denosumab and Nivolumab-Denosumab in Patients with Unresectable Stage III and IV Melanoma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18+Age Over 18

Skin<br/>CancersCancer LocationSkin
Cancers

Systemic therapy | SkinMelanoma (Skin)

Trial Overview Read MoreRead more

This phase I/II trial is testing the addition of a new treatment (denosumab) to standard immunotherapies for patients with metastatic melanoma.
 

This trial is treating patients with melanoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Phase Ib/II Trial of Ipilimumab-Nivolumab-Denosumab and Nivolumab-Denosumab in Patients with Unresectable Stage III and IV Melanoma

Other Non-Commercial Sponsor

Peter MacCallum Cancer Centre

Summary

This is a randomised controlled trial. Patients in Arm A of the trial, will receive intravenous (IV) nivolumab (3 mg/kg IV) every 2 weeks for 4 doses and subcutaneous (SC) denosumab (120 mg) on D1, D8, D15 and D29. Thereafter, IV nivolumab (480 mg) and SC denosumab (120 mg) every 4 weeks for a total of 24 months Patients in Arm B will recieve ipilimumab (3 mg/kg) in combination with nivolumab (1 mg/kg IV) every 3 weeks for 4 doses, with SC denosumab (120 mg) given on D1, D8, D15, D29, D57. This will be followed by nivolumab 480 mg IV and denosumab 120 mg SC ever 4 weeks for a total of 24 months. Responses to treatment and progression will be regularly monitored until the last patient has been in survival follow-up for 5 years. Tumour and blood samples will also be taken to determine possible predictive biomarkers.

Recruiting Hospitals Read MoreRead more

Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Bendigo Hospital
Bendigo
Ms Amanda Rundle
arundle@bendigohealth.org.au
03 5454 8821

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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