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Anti-PD 1 Brain Collaboration for Patients With Melanoma Brain Metastases

NCT02374242 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-12-10

No results posted yet for this study

Summary

The purpose of this research project is to test the effectiveness of nivolumab versus nivolumab together with ipilimumab for the treatment of melanoma brain metastases.

Patients are eligible to join this study if they are aged 18 years or above and have been diagnosed with melanoma with brain metastases.

Conditions

Interventions

DRUG

Nivolumab

Nivolumab is a fully human monoclonal antibody directed against the negative immunoregulatory human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1/PCD-1) with immunopotentiation activity.

DRUG

Ipilimumab

Ipilimumab is a recombinant, human monoclonal antibody that binds to the cytotoxic T lymphocyte-associated antigen 4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Ipilimumab binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation. The mechanism of action of ipilimumab's effect in patients with melanoma is indirect, possibly through T-cell mediated anti-tumour immune responses.

Sponsors & Collaborators

  • Melanoma and Skin Cancer Trials Limited

    collaborator OTHER

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Melanoma Institute Australia

    lead OTHER

Principal Investigators

  • Georgina Long · Melanoma Institute Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-04
Primary Completion
2017-09-04
Completion
2028-12-31

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02374242 on ClinicalTrials.gov