CLINICAL TRIAL

Cobimetinib for Melanoma

Metastatic
Recruiting · 18+ · All Sexes · Boston, MA

This study is evaluating whether a drug may help treat uveal melanoma.

See full description

About the trial for Melanoma

Eligible Conditions
Metastatic Melanoma · Melanoma

Treatment Groups

This trial involves 2 different treatments. Cobimetinib is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
IN10018
DRUG
Experimental Group 2
Cobimetinib
DRUG
+
IN10018
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobimetinib
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Written informed consent provided.
Histologically or cytologically confirmed metastatic uveal melanoma or Metastatic NRAS-mutant melanoma .
At least one measurable lesion can be accurately measured per RECIST 1.1 by investigator.
ECOG performance status of 0 or 1.
Adequate organ system functions as defined in the protocol
A male subject must agree to use contraception as detailed in protocol during the treatment period and through 30 days after the last dose of study treatment and must refrain from donating sperm during this period.
A female subject is eligible to participate if she is not pregnant, not breastfeeding.
Key
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Cobimetinib will improve 2 primary outcomes, 11 secondary outcomes, and 1 other outcome in patients with Melanoma. Measurement will happen over the course of Cycle 1 and Cycle 3.

Pharmacokinetics (PK) : Vd
CYCLE 1 AND CYCLE 3
Apparent volume of distribution(Vd)
CYCLE 1 AND CYCLE 3
Pharmacokinetics (PK) : CL/F
CYCLE 1 AND CYCLE 3
apparent clearance (CL/F)
CYCLE 1 AND CYCLE 3
Pharmacokinetics (PK) : Cmax
CYCLE 1 AND CYCLE 3
Peak Plasma Concentration (Cmax)
CYCLE 1 AND CYCLE 3
Pharmacokinetics (PK) : t1/2
CYCLE 1 AND CYCLE 3
Elimination half-life (t1/2)
CYCLE 1 AND CYCLE 3
Pharmacokinetics (PK) : AUC
CYCLE 1 AND CYCLE 3
Area under the plasma concentration versus time curve (AUC)
CYCLE 1 AND CYCLE 3
Pharmacokinetics (PK) : tmax
CYCLE 1 AND CYCLE 3
Time to Cmax (tmax)
CYCLE 1 AND CYCLE 3
See More

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes melanoma?

Melanomas mostly result from inheriting gene mutations. The most common gene mutations are found in the CDKN2 A gene. Other genes may be involved in melanoma genesis. Melanoma patients show alterations in the DNA base-sequence content of tumours. The mechanism whereby the DNA changes are induced is unclear, but the DNA sequence alterations in tumours are probably related to melanomagenesis through mechanisms such as epigenetic modifications. The mechanism of CDKN2A mutations causing tumours warrants further research.

Anonymous Patient Answer

What are the signs of melanoma?

Visual examination of the skin and any abnormalities like freckles, telangiectasis or nevi warrant further discussion. The presence of melanocytosis is not a guarantee of malignancy in melanoma. Clinicians should look carefully for melanoma and consider a dermoscopy if appropriate.

Anonymous Patient Answer

Can melanoma be cured?

For the past 40 years, advances in therapy have improved outcomes, but in only 2% to 3% of the time and many patients go years without relapse. The question then arises as to when melanoma is truly cured; and, if it's not now, when is its optimum time to start treatment to attempt a cure? A cure is truly possible, but one that we should strive for. This article will focus more on current and future treatment options and discuss aspects of the biology of melanoma that might lead to cures.

Anonymous Patient Answer

Does cobimetinib improve quality of life for those with melanoma?

Treatment with cobimetinib was associated with improvements in quality of life for patients with metastatic melanoma that were similar to those reported for patients on placebo. These data suggest that cobimetinib is an effective targeted therapy in metastatic melanoma with good tolerability.

Anonymous Patient Answer

What are common treatments for melanoma?

Many common modalities have been utilized to treat melanoma. They include surgical resection, elective radiation, topical therapy, chemotherapy, biologic therapy, and immunotherapy. Patients should expect to be hospitalized and treated at least temporarily while pursuing the best treatment in a clinical trial. Although many patients are managed by primary care physicians, some melanoma patients are managed by oncologists.

Anonymous Patient Answer

How many people get melanoma a year in the United States?

There were an estimated 40,000 new cases of cutaneous melanoma in 2014 in the USA. Melanogenesis is the cause of most cases. The highest rates (43%) of melanoma occurred in individuals younger than 55 during the early 1980s. A significant number of new cases occur among those with non-Hispanic black or Asian race.

Anonymous Patient Answer

What is melanoma?

Melanomas form through the growth of a pre-melanocyte; this is when the melanocyte comes into existence from a multipotent stem-cell. Most of the melanomas are not present at birth. We summarize information about the symptoms and signs of melanoma as well as the diagnosis and treatment options.

Anonymous Patient Answer

Who should consider clinical trials for melanoma?

Patients are at high risk as many are younger than 55, in a poorer socioeconomic class, live in urban centers, have poorer health, and present with worse disease characteristics than typical clinical trial candidates. However, there are no reliable data on the likelihood of these patients being eligible for melanoma clinical trials.

Anonymous Patient Answer

How does cobimetinib work?

A number of the targets, that were inhibited, are involved in tumor angiogenesis. There are a number of small molecule inhibitors that may lead to improved clinical outcomes. Cobimetinib has the added potential to block angiogenesis, leading to an increase in tumor burden. Results from a recent paper of this study indicate that further studies are needed to determine whether the anticancer efficacy of cobimetinib is mediated by a reduction of tumor angiogenesis or via direct cytostatic effects of the drug against the tumor cells.

Anonymous Patient Answer

How quickly does melanoma spread?

Melanoma can spread before or shortly after it is detected: as early as 10 years or as late as 30 years or more from when it first develops. In order for that detection to occur a lot of people (80-90%) have a family member with the disease or have had melanoma at some time. A person with an early detection would be able to have a treatment which might be curative.

Anonymous Patient Answer

What are the chances of developing melanoma?

Age at diagnosis (<39 and 40-64 years), black race, male gender and, if younger than 50 years, a family history for melanoma are associated with increased risk for developing primary melanoma, but are not significant predictors of the disease.

Anonymous Patient Answer

Does melanoma run in families?

The findings of a positive clustering of melanoma in families of melanoma-prone individuals suggests that there are genetic factors important to melanoma genesis that predispose families to development of the disease. Further studies are needed to define the genes and to understand the factors involved in the pathogenesis of melanoma in family members and their offspring.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Melanoma by sharing your contact details with the study coordinator.