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Clinical Trials/ACTRN12617000772347
ACTRN12617000772347
Completed
Phase 1

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

Peter MacCallum Cancer Centre0 sites52 target enrollmentStarted: May 26, 2017Last updated:
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Overview

Phase
Phase 1
Status
Completed
Sponsor
Peter MacCallum Cancer Centre
Enrollment
52
OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Non-randomised trial
Primary Purpose
Treatment
Masking
Open (masking not used)

Eligibility Criteria

Ages
18 Years to o limit (—)
Sex
All

Inclusion Criteria

  • •1\.Histologically confirmed unresectable or metastatic melanoma as per AJCC 7 staging system.
  • •2\.Age greater than or equal to 18 years
  • •3\.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\.
  • •4\.Patient willing and able to provide written informed consent.
  • •5\.No prior systemic therapy for unresectable or metastatic melanoma. Prior adjuvant or neoadjuvant melanoma therapy with a BRAF or MEK inhibitor is permitted if it was completed at least 6 months prior to allocation, and all related adverse events have either returned to baseline or resolved.
  • •6\.Willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
  • •7\.Measurable disease by CT or MRI per RECIST 1\.1 criteria.
  • •8\.Patients with asymptomatic brain metastasis may be considered for enrollment. These patients can have up to 3 lesions that are lesser than or equal to 1\.5 cm in diameter. The brain metastasis may be naïve to local therapy or have previously received local therapy (surgery, stereotactic radiotherapy/radiosurgery but not whole brain radiotherapy) and are stable. Asymptomatic from brain metastases at study entry implies that these patients are without corticosteroid, antiepileptics, analgesia or any other treatment for the management of neurological symptoms. Patients with completely resolved neurological symptoms are permitted.
  • •9\.At least 1 week since the completion of prior therapy, including surgery or radiotherapy.
  • •10\.Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomisation/registration

Exclusion Criteria

  • •1\.Patients are excluded if they have symptomatic, large volume brain metastases and/or any evidence of leptomeningeal disease. Large volume brain metastasis for this study is defined as more than 3 brain metastasis and/or any of the brain metastasis being greater than 1\.5 cm in dimension. Note: patients with larger brain metastasis (up to 3 cm) that has been adequately treated with prior surgery or stereotactic radiation are permitted to be enrolled as long as they have adequately recovered from the local therapy.
  • •2\.Neurological symptoms from brain metastases present at baseline (resolved neurological symptoms, prior to enrolment, are permitted).
  • •3\.Patients with uveal melanoma are excluded.
  • •4\.Prior exposure to a CTLA\-4 inhibitor (e.g. ipilimumab, tremelimumab), PD\-1 inhibitor (e.g. nivolumab, pembrolizumab), PD\-L1 inhibitor (e.g. MEDI\-4736\), PD\-L2 inhibitor, or any other antibody or drug specifically targeting T\-cell co\-stimulation or immune checkpoint pathways.
  • •5\.Prior systemic treatment for unresectable or metastatic melanoma.
  • •6\.Prior treatment with denosumab.
  • •7\.Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
  • •8\.Life expectancy of \= 6 months.
  • •9\.Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw.
  • •10\.Active dental condition, which requires major oral surgery. Patients who have undergone a tooth extraction in less than 4 weeks should be clinically reviewed to ensure they have healed well.

Investigators

Sponsor
Peter MacCallum Cancer Centre

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