Atezolizumab for Melanoma

Phase-Based Estimates
2
Effectiveness
3
Safety
Sharett Institute - Hadassah Hebrew University Medical Center, Jerusalem, Israel
Melanoma
Atezolizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Melanoma

Study Summary

This study is evaluating whether a combination of drugs can improve the survival of people with melanoma.

See full description

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Atezolizumab will improve 1 primary outcome and 13 secondary outcomes in patients with Melanoma. Measurement will happen over the course of Pre-dose (0 hour) and 3 to 6 hours post dose on Day 15 of Cy 1 and 4 (1 Cy = 28 days).

2 years
Percentage of Participants Who Have Survived at 2 Years
Month 33
Percentage of Participants With Adverse Events and Serious Adverse Events
Month 33
Duration of Response, as Determined by Investigator Using RECIST v1.1
Overall Survival
Percentage of Participants With Objective Response, as Determined by Investigator Using RECIST v1.1
Progression-Free Survival (PFS), as Determined by Independent Review Committee Using RECIST v1.1
Progression-Free Survival (PFS), as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time to Deterioration in Global Health Status Using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Scale Score
Time to Deterioration in Physical Functioning Using EORTC QLQ-C30 Physical Functioning Scale Score
Day 28
Plasma Concentration of Cobimetinib Dose: 20/40 mg
Plasma Concentration of Cobimetinib Dose: 60 mg
Plasma Concentration of Vemurafenib
Month 33
Serum Concentration of Atezolizumab
Month 90
Percentage of Participants Positive for Anti-Drug Antibodies (ADA) to Atezolizumab

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

No Control Group
Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib Placebo
Placebo group

This trial requires 514 total participants across 2 different treatment groups

This trial involves 2 different treatments. Atezolizumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib PlaceboRun-In Period (Cycle 1=28 days): Participants will receive vemurafenib 960 mg (four, 240 mg tablets) PO BID along with cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21 followed by vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 22 to 28 and vemurafenib placebo (1 tablet) PO BID on Days 22 to 28. Triple Combination Period (Cycle 1 onwards): Participants will receive atezolizumab 840 mg IV infusion on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28 of each 28-day cycle. Study treatment will continue until investigator-determined disease progression, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurs first.
Atezolizumab Placebo + Cobimetinib + VemurafenibRun-In Period (Cycle1=28 days): Participants will receive vemurafenib 960 milligrams (mg) (four, 240 mg tablets) orally (PO) twice a day (BID) along with cobimetinib 60 mg (three, 20 mg tablets) PO once a day (QD) on Days 1 to 21 followed by vemurafenib 960 mg (four, 240 mg tablets) PO BID on Days 22 to 28. Triple Combination Period (Cycle 1 onwards): Participants will receive ATZ placebo by intravenous (IV) infusion on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21, and vemurafenib 960 mg (four, 240 mg tablets) PO BID on Days 1 to 28 of each 28-day cycle. Study treatment will continue until investigator-determined disease progression, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurs first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vemurafenib
FDA approved
Atezolizumab
FDA approved
Cobimetinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Closest Location

University of Alabama at Birmingham - Birmingham, AL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
patients were enrolled Patients with melanoma that has spread to other parts of the body (Stage IV) or is in a very advanced stage and cannot be surgically removed (Stage IIIc) were enrolled in the study. show original
Testing of tumor tissue for the BRAFv600 mutation can be done using a clinical mutation test that is approved by the local health authority. show original
This means that a fetus is considered viable if it has a life expectancy of at least 18 weeks. show original
For participants not receiving therapeutic anticoagulation: their International normalized ratio (INR) or activated partial thromboplastin time (aPTT) was less than or equal to (</=) 1.5*upper limit of normal (ULN) within 28 days prior to initiation of study treatment. show original
Subject to prior systemic anti-cancer therapy for melanoma (example: chemotherapy, hormonal therapy, targeted therapy, immunotherapy, or other biologic therapies), with the exception of adjuvant treatment with interferon (IFN), interleukin (IL)-2, or vaccine therapies or herbal therapies. show original
For participants receiving therapeutic anticoagulation: Their anticoagulant regimen must have been stable for the past 28 days, and their INR must have been stable during that time as well. show original
Females of child bearing potential and males with female partners must and use of contraceptive methods with a failure rate of less than or equal to (</=)1% per year is required during treatment and for 6 months post treatment. Males should not expose pregnant partners to sperm and refrain from donating sperm for 6 months post treatment. Women must refrain from donating eggs during this same period
This doctor has an ECOG performance status of 0 or 1, which means that they are in good health and are able to carry out normal activities. show original
Any measurable disease that is not located in the central nervous system. show original

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 are common treatments for melanoma?

Add answer

Patient-centred, psychosocial and supportive care is frequently utilized in the treatment of melanoma. It is very important to incorporate these treatments into the multidisciplinary treatment of the disease.

Unverified Answer

What is melanoma?

Add answer

Melanoma is a type of cancer that begins in the melanocytes of the skin. In many cases, it is not detected until it has invaded neighboring tissue, spread to other sites in the body, or has metastasized to local lymph nodes.\n

Unverified Answer

What causes melanoma?

Add answer

Melanoma is one of the most common skin cancers, and its incidence continues to rise in North America and Europe. Melanoma develops from melanocytes, and a mutation and a single growth stimulus can result in nevi (benign, borderline and [malignant melanoma](https://www.withpower.com/clinical-trials/malignant-melanoma)), which can spread to the skin and become metastasising tumors (melanoma). The most important risk factors for melanoma, in terms of the number of deaths, are: (i) age; (ii) occupation, e.g., in agricultural workers and exposure to chemicals in the workplace; (iii) skin colour; and (iv) gender.

Unverified Answer

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

Add answer

The prevalence of melanoma is declining over time, possibly because of increased awareness among the general public of melanoma risks associated with exposure to UV radiation. Results from a recent paper confirms a higher prevalence of melanoma in some populations than others, as do studies conducted elsewhere.

Unverified Answer

What are the signs of melanoma?

Add answer

Some signs of melanoma include moles that tend to grow quickly, itch, change in color, or may bleed. In some cases melanoma may be evident as an invasive tumor that looks like [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer). These signs may be present long before the cancer can even be diagnosed.

Unverified Answer

Can melanoma be cured?

Add answer

The evidence in the current literature does not support a causal connection of metastatic melanoma with any of the treatments listed herein, and in particular no evidence has shown a cure for metastatic melanoma. The only available evidence of efficacy is in the prevention setting as reported in a previous literature review. For this reason, we recommend that melanoma patients with metastatic disease and suitable for a systemic treatment, or those who are in remission for more than 6 months, should be offered adjuvant therapy with a curative intent.

Unverified Answer

Is atezolizumab safe for people?

Add answer

Atezolizumab was well tolerated, with no life-threatening or very serious allergic reactions reported and no fatalities were reported. Side effects were more common to other immune checkpoint inhibitors but were in general tolerable. No treatment interruptions by the patient was reported at this dose.

Unverified Answer

What are the common side effects of atezolizumab?

Add answer

Among all SAEs, skin reactions appear to occur in roughly the same frequency as those described in the clinical trials of the first-line treatment of metastatic renal cell carcinoma (33 vs 40%). The most common side effects were rash, swelling, pruritus, dyspnoea, and fatigue.

Unverified Answer

Have there been other clinical trials involving atezolizumab?

Add answer

At this time, there are only one or two ongoing clinical trials ongoing for this agent. These trials are either comparing it with interleukin-2 or interferon-α. Although the results are awaited, the safety profile and the efficacy of atezolizumab are comparable to those of other T-cell-based agents.

Unverified Answer

What is the average age someone gets melanoma?

Add answer

If the age is known, then the risks may change. For example, the risks of metastasizing melanoma are highest before 60 years of age. This may change how treatment options are viewed by treatment specialists, as it is known that older people have longer lifespans and are therefore more likely to live for the treatment. The average age of diagnosis differs by type of skin cancer. The average age of diagnosis in North America is about the age of 40. For people in the United Kingdom and Australia an average age of diagnosis is between 50 and 60 (see “Distribution” below). In the United States, the average age of diagnosis is about 60 years for melanoma.

Unverified Answer

How serious can melanoma be?

Add answer

Although melanoma is curable, it represents the deadliest type of cancer in some high-income, densely populated countries. In Australia and New Zealand, melanoma is the ninth-most common form of cancer in women and the fourth-most common in men. More than half of melanoma cases develop on areas of the skin formerly exposed to the sun, suggesting that a lifestyle factor such as excessive sun exposure is a leading risk factor for melanoma. In the US, melanoma is the second-most-common cancer among women after breast cancer.

Unverified Answer

What is the survival rate for melanoma?

Add answer

Survival from melanoma is low. Some of the treatment decisions that are made, or not made, are based on how far metastatic melanoma has spread when it is diagnosed. Survival has improved dramatically in recent years with early detection of melanoma patients and improved treatment options.

Unverified 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.