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Melanoma Metastasized to the Brain and Steroids

NCT03563729 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-07-13

No results posted yet for this study

Summary

This clinical trial is to clarify whether treatment with a checkpoint inhibitor alone (pembrolizumab) or two in combination (ipilimumab and nivolumab), results in clinical benefit for MM patients with brain metastases and in need of steroid treatment. Patients will be treated in four arms depending on steroid dose level at inclusion (\> 10 \< 25 mg prednisolone or \> 25 mg prednisolone) and treatment (pembrolizumab alone or the combination of ipilimumab and nivolumab).

Conditions

  • Malignant Melanoma

Interventions

DRUG

Pembrolizumab Injection [Keytruda]

Alone

DRUG

Ipilimumab Injection [Yervoy]

In combination with nivolumab.

DRUG

Nivolumab Injection [Opdivo]

In combination with ipilimumab.

DRUG

Encorafenib

In combination with binimetinib

DRUG

Binimetinib

In combination with encorafenib

DRUG

Dabrafenib

In combination with dabrafenib

DRUG

Trametinib

In combination with trametinib

Sponsors & Collaborators

  • Inge Marie Svane

    lead OTHER

Principal Investigators

  • Troels H Borch, PhD · Center for Cancer Immune Therapy, Department of Hematology and Department of Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-06
Primary Completion
2024-06-01
Completion
2028-06-06

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

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 NCT03563729 on ClinicalTrials.gov