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Monoclonal Antibodies
Atezolizumab + Cobimetinib + Vemurafenib for Melanoma
Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Naive to prior systemic anti-cancer therapy for melanoma except adjuvant treatment with interferon (IFN), interleukin (IL)-2, or vaccine therapies or herbal therapies
Documentation of BRAFv600 mutation-positive status in melanoma tumor tissue through use of a clinical mutation test approved by the local health authority
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new combination cancer treatment in people who have melanoma that has spread or can't be removed by surgery.
Who is the study for?
This trial is for adults with untreated BRAFv600 mutation-positive advanced melanoma. They must be able to use effective contraception, have no other cancers or severe diseases, and not be pregnant or breastfeeding. Participants should have a life expectancy of at least 18 weeks and an ECOG status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of combining Atezolizumab (an immunotherapy drug) with Cobimetinib and Vemurafenib (targeted cancer therapies) versus placebo versions in patients who haven't had systemic anti-cancer treatment for their melanoma. It's a Phase III trial where participants are randomly assigned to either the drug combination or placebo group.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, high blood pressure due to Cobimetinib, skin rash from Vemurafenib, liver problems, fatigue, joint pain, sun sensitivity, and possible infusion-related reactions from Atezolizumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have melanoma and haven't had systemic anti-cancer treatments, except for certain adjuvant therapies.
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My melanoma has a BRAFv600 mutation.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer can be measured and is not in my brain or spinal cord.
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My melanoma is at an advanced stage and cannot be surgically removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival (PFS), as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Secondary outcome measures
Duration of Response, as Determined by Investigator Using RECIST v1.1
Overall Survival
Percentage of Participants Positive for Anti-Drug Antibodies (ADA) to Atezolizumab
+10 moreSide effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
2Treatment groups
Experimental Treatment
Group I: Atezolizumab Placebo + Cobimetinib + VemurafenibExperimental Treatment3 Interventions
Run-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.
Group II: Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib PlaceboExperimental Treatment4 Interventions
Run-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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobimetinib
2017
Completed Phase 3
~2660
Vemurafenib
2015
Completed Phase 3
~3100
Atezolizumab
2017
Completed Phase 3
~5860
Atezolizumab Placebo
2017
Completed Phase 3
~1960
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,540 Total Patients Enrolled
49 Trials studying Melanoma
57,990 Patients Enrolled for Melanoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
887,988 Total Patients Enrolled
50 Trials studying Melanoma
42,405 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart's pumping ability is below normal or less than 50%.You are allergic to certain biopharmaceutical drugs.I have not had cancer, other than BRAFv600 positive melanoma, in the last 3 years.I have a significant liver condition or an active liver infection.I am currently taking certain medications or have received specific vaccines.You have a history of eye problems that could make the study risky for you.I do not have any severe illnesses that are not under control besides cancer.You are expected to live for at least 18 weeks.I have had a stem cell or organ transplant in the past.You have a current or past autoimmune disease or immune system weakness.I have diabetes that is not well-managed.I have a history of nutrient absorption problems or significant metabolic issues.My blood thinner medication and INR levels have been stable for the last 28 days.My cancer has spread to my brain or its coverings.I will avoid exposing pregnant partners to sperm and not donate sperm for 6 months after treatment.I have melanoma and haven't had systemic anti-cancer treatments, except for certain adjuvant therapies.My melanoma is at an advanced stage and cannot be surgically removed.I am using or willing to use effective birth control during and for 6 months after treatment.I have not had a stroke or temporary paralysis in the last 6 months.My cancer can be measured and is not in my brain or spinal cord.My melanoma has a BRAFv600 mutation.I am fully active or restricted in physically strenuous activity but can do light work.I have a history of serious heart problems.I have active tuberculosis.If you are not taking blood thinners, your blood clotting tests should be within a certain range in the 28 days before starting the study treatment.I have not had severe bleeding in the last 4 weeks.I have untreated or worsening brain or spinal cord lesions.I have not had a traumatic injury or palliative radiotherapy in the last 2 weeks.I have not had major surgery in the last 4 weeks.I have a history of lung conditions or signs of lung inflammation.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib Placebo
- Group 2: Atezolizumab Placebo + Cobimetinib + Vemurafenib
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the government's official thoughts on Atezolizumab?
"Atezolizumab is classified as a Phase 3 medication, meaning that while there is data supporting its efficacy, multiple rounds of testing have also confirmed its safety. Our team rates it with a 3."
Answered by AI
What are Atezolizumab's most common indications?
"Atezolizumab is a medication that has been approved to treat small cell lung cancer, but it can also be used off-label to manage metastatic melanoma, non-small cell lung carcinoma, and unresectable melanoma."
Answered by AI
Is this a clinical trial that is breaking new ground?
"Global clinical trial data shows that there are 401 ongoing studies involving Atezolizumab across 74 countries and 1751 cities. The first Atezolizumab trial was sponsored by Hoffmann-La Roche in 2008. That study completed Phase 2 drug approval with 720 participants. Since then, 143 more trials have been conducted."
Answered by AI
How many people are currently enrolled in this clinical trial?
"Unfortunately, this study is not enrolling patients at the moment. However, it is important to note that this trial was originally posted on 1/13/2017 and was most recently edited on 10/4/2022. There are presently 781 clinical trials actively enrolling patients with melanoma and 401 trials for Atezolizumab actively enrolling patients."
Answered by AI
Would it be possible to get a list of the hospitals in this city where this clinical trial is taking place?
"To limit patient burden, the 15 sites for this trial are situated so that there is likely a location near you. The participating cities are Park Ridge, Tempe and Springdale among others."
Answered by AI
What other scientific research has been conducted using Atezolizumab?
"Currently, there are 401 active clinical trials studying Atezolizumab. Of these, 74 have progressed to Phase 3 testing. The majority of research locations for Atezolizumab are in Tampa, Florida; however, there are a total of 19939 sites running studies concerning this treatment across the world."
Answered by AI
Are patients still being accepted into this clinical trial?
"According to the latest information available on clinicaltrials.gov, this particular trial is not looking for patients at the moment. The study was first posted on 1/13/2017, with the last update coming on 10/4/2022. Even though this research isn't searching for participants right now, there are 1182 other studies that are currently doing so."
Answered by AI
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