Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Melanoma

Neoplasm Metastasis

Brain Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Vemurafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Vemurafenib (960 mg twice a day) will be taken on Days 1 - 28 of each 28-day treatment cycle. The first dose of vemurafenib should be taken in the morning, and the second dose should be taken in the evening. Vemurafenib can be taken with or without a meal and should be taken with a glass of water.

Cobimetinib (60 mg once a day) will be taken on Days 1 - 21 of each 28-day treatment cycle. The cobimetinib tablet should be taken at approximately the same time each day in the morning with the vemurafenib dose, but no later than 4 hours after the scheduled time. Cobimetinib can be taken with or without a meal and should never be chewed, cut, or crushed and should be taken with a glass of water.

60mg once a day; will be taken on days 1-21 of each 28 day treatment cycle; will be taken in combination with Vemurafenib;

Cobimetinib

960mg twice a day; 28 day treatment cycle; will be taken in combination with Cobimetinib;

Melissa Burgess, MD

Richard Carvajal, MD

Anna Pavlick, MD

Mohammed Milhem, MD

Ravi Amaravadi, MD

Harriet Kluger, MD

The purpose of this study is to evaluate the effectiveness of the combination of vemurafenib with cobimetinib in patients with active melanoma brain metastases.

Phase II Study of Cobimetinib in Combination With Vemurafenib in Active Melanoma Brain Metastases

Change in overall size of the sum of diameters from baseline of up to 5 intracranial target lesions in response to study treatment, achieved by individual patients.

Response to study treatment achieved by individual patients as indicated by an overall change in size of the sum of diameters from baseline of up to 5 intracranial target lesions and up to 5 extracranial target lesions.

Time (number of months) from first documented evidence of overall Complete Response (CR) or Partial Response (PR) until time of first documented disease progression or death due to any cause (for individual patients). Progression as defined by RECIST 1.1 (Response Evaluation Criteria In Solid Tumors) is a ≥ 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.

Number of months of survival for individual patients.

Change in relative apparent diffusion coefficient (rADC) as measured by MRI as early predictor of response value/result for each patient

The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is used to measure general quality of life (QOL) that reflects symptoms or problems associated with brain malignancies across 5 scales. The brain subscale is usually used along with the core (general) questionnaire that includes 27 items. The measure yields information about total QOL, as well as information about the dimensions of physical well-being, social/family well-being, emotional well being, functional well-being, and disease-specific concerns. Patients rate all 5 items using a five-point Likert scale ranging from 0 "not at all" to 4 "very much." Overall, higher ratings suggest higher QOL. Items are totaled to produce the following subscales, along with an overall QOL score: physical well-being (7 items); social/family well-being (7 items); emotional well-being (6 items); functional well-being (7 items); and concerns relevant to patients with brain tumors (23 items). Scoring range is 0-200.

Genentech, Inc.

Assistant Professor

Vemurafenib (960 mg twice a day) taken on Days 1 - 28 of each 28-day treatment cycle. Cobimetinib (60 mg once a day) taken on Days 1 - 21 of each 28-day treatment cycle.

Cobimetinib in Combination With Vemurafenib

Patient 1

Patient 2

Patient 3

Patient 4

Patient 5

Age, Customized

Sex: Female, Male

Patient #1

Patient #2

Patient #4

Patient #5

Patients who received study treatment and were assessed by MRI every 8 weeks.

Objective Intracranial Response (OIRR)

Overall Response

Progression-free Survival (PFS)

Overall Survival (OS)

Patients for whom response duration data was obtainable in those that received MRI tumor assessments every 8 weeks.

Duration of Response

Data were not able to be collected and thus zero participants were analyzed for this outcome.

Immune Modulation in Peripheral Blood

Zero participants were analyzed for this outcome.

Early Markers of Progression in Peripheral Blood

Patient #1 - Cycle 1

Patient #1 - Cycle 2

Patient #1 - Cycle 3

Patient #1 - Cycle 4

Patient #2 - Cycle 1

Patient #2 - Cycle 2

Patient #2 - Cycle 3

Patient #2 - Cycle 4

Patient #4 - Cycle 1

Patient #4 - Cycle 2

Patient #4 - Cycle 3

Patient #4 - Cycle 4

Patient #4 - Cycle 5

Patient #4 - Cycle 6

Patient #5 - Cycle 1

Patient #5 - Cycle 2

Patient #5 - Cycle 3

Health-related Quality of Life as Measured by The Functional Assessment of Cancer Therapy (FACT) - Brain (FACT-Br)

Overall Study

Spots Global Cancer Trial Database for Phase II Study of Cobimetinib in Combination With Vemurafenib in Active Melanoma Brain Metastases

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial