Dose starting at 4 mg daily (for patients randomized to the Dexamethasone arm).

Dose starting at 25 mg/day (a calculation of equipotent steroid equivalencies will be used).

Brain Metastases, Adult

The study intervention is defined as treatment with either prednisone or dexamethasone as palliative therapy for the control of neurological symptoms; patients with symptomatic brain metastases with a requirement for glucocorticoid therapy will be treated with an available, standard-of-care immune checkpoint inhibitor regimen.

Glucocorticoid therapy

Cross Cancer Institute

Accelerated Checkpoint Therapy for Any Steroid Dependent Patient With Brain Metastases

An Interventional, Randomized Phase II Study Investigating the Efficacy of Immune Checkpoint Inhibitors While Corticosteroid Therapy is Required for Patients With Symptomatic Brain Metastases.

Objective response rate will be determined utilizing RECIST 1.1 criteria. Baseline staging diagnostic imaging (CT and/or MRI studies) will be performed in advance of beginning treatment and repeated 6 weeks following treatment initiation and at 12 week intervals thereafter.

Defined as the time interval between first radiographic documentation of intracranial metastatic disease and initiation of systemic immunotherapy.

Secondary study outcomes include progression-free and overall survival (PFS, OS). PFS is defined as the time between the date of treatment initiation and the date of disease progression (determined utilizing RECIST 1.1 criteria) or death (whatever the cause), whichever occurs first. For participants who remain alive and whose disease has not progressed, PFS will be censored on the date of last visit/contact with disease assessments. PFS will be based on the disease assessment or date of death provided by the investigator. OS is defined as the time between the date of treatment initiation and the date of death (whatever the cause). For participants who remain alive OS will be censored on the date of last visit/contact with disease assessments. OS will be based on the date of death provided by the investigator.

An analysis of patient-reported quality of life will be conducted utilizing the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC Brain Cancer Module (EORTC QLQ-BN20) questionnaires). Quality of life questionnaires will be administered to participants following enrolment to study but prior to initiation of immunotherapy. Follow-up questionnaires will be administered as part of the standard of care immunotherapy pre-treatment starting 6 weeks from Cycle 1 and every 6 weeks thereafter until end of treatment. Quality of life questionnaires should be administered prior to investigator assessment at each indicated time-point.

The Common Terminology Criteria for Adverse Events (CTCAE, version 4.03) will be used to categorize treatment related and non-treatment related adverse events.

AHS Cancer Control Alberta

Open label, two cohort, permuted block randomization phase II study.

IMCgp100 will be injected cutaneously or subcutaneously into the metastasis, and peritumoral area if applicable

Melanoma

Advanced Disease

Unresectable

a monoclonal T cell receptor anti-CD3scFv fusion protein

IMCgp100 injection

Abramson Cancer Center of the University of Pennsylvania

IMCgp100 in Advanced Unresectable Melanoma

A Phase 0, Exploratory Study of the Pharmacodynamics of a Single Intratumoral Dose of IMCgp100, a Monoclonal Receptor Anti-CD3 scFv Fusion Protein, in Subjects With Advanced Unresectable Melanoma

To determine the safety and pharmacodynamic properties of single intratumoral doses of IMCgp100 in the setting of advanced unresectable melanoma.
Tumor Lesions, peripheral blood pre- and post-injection will be used to determine the safety and pharmacodynamic properties of single intratumoral doses of IMCgp100 in the setting of advanced unresectable melanoma

Will be used to determine the safety and tolerability of IMCgp100 at subtherapeutic doses.

will be used to determine the safety and tolerability of IMCgp100 at subtherapeutic doses.

will be used to determine the safety and tolerability of IMCgp 100 at subtherapeutic doses.

will be used to examine peripheral cytokine measurements as evidence of product immunoactivity and peripheral T and NK cell numbers, phenotype and activation marker status.

University of Pennsylvania

administered iv for 3 h every 21 days; dose reductions to 12 or 9 mg/m2 ZK-EPO were allowed in order to manage any treatment-related toxicity.

melanoma/seizures

Accelerated Checkpoint Therapy for Any Steroid Dependent Patient With Brain Metastases

IMCgp100 in Advanced Unresectable Melanoma

Epothilone in Recurrent Glioblastoma Patients

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