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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
Females of childbearing potential and males with female partners must use contraceptive methods with a failure rate of </=1% per year 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Pivotal Trial

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 below
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I am using or willing to use effective birth control during and for 6 months after treatment.
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I will avoid exposing pregnant partners to sperm and not donate sperm for 6 months after treatment.
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My melanoma is at an advanced stage and cannot be surgically removed.
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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 blood thinner medication and INR levels have been stable for the last 28 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
27%
Fatigue
25%
Decreased appetite
24%
Cough
19%
Dyspnoea
19%
Asthenia
18%
Constipation
18%
Pyrexia
18%
Nausea
16%
Diarrhoea
13%
Arthralgia
12%
Vomiting
12%
Anaemia
11%
Back pain
11%
Musculoskeletal pain
11%
Rash
10%
Headache
9%
Oedema peripheral
9%
Weight decreased
9%
Chest pain
9%
Insomnia
9%
Pruritus
9%
Pain in extremity
8%
Dizziness
7%
Upper respiratory tract infection
7%
Aspartate aminotransferase increased
7%
Myalgia
7%
Haemoptysis
6%
Influenza like illness
6%
Nasopharyngitis
6%
Alanine aminotransferase increased
6%
Bronchitis
6%
Productive cough
5%
Musculoskeletal chest pain
5%
Depression
5%
Dry skin
4%
Abdominal pain
4%
Urinary tract infection
4%
Neuropathy peripheral
4%
Paraesthesia
3%
Stomatitis
3%
Dysgeusia
3%
Pneumonia
2%
Malaise
2%
Pleural effusion
2%
Neutropenia
1%
Lacrimation increased
1%
Respiratory tract infection
1%
Sepsis
1%
Pneumonitis
1%
Mucosal inflammation
1%
Bone pain
1%
Pulmonary embolism
1%
Peripheral sensory neuropathy
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab
Docetaxel

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
Atezolizumab
2016
Completed Phase 3
~6040
Atezolizumab Placebo
2017
Completed Phase 3
~1960
Cobimetinib
2015
Completed Phase 3
~2620
Vemurafenib
2015
Completed Phase 3
~3120

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,421 Previous Clinical Trials
1,080,124 Total Patients Enrolled
49 Trials studying Melanoma
57,990 Patients Enrolled for Melanoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,194 Previous Clinical Trials
886,666 Total Patients Enrolled
50 Trials studying Melanoma
42,468 Patients Enrolled for Melanoma

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02908672 — Phase 3
Melanoma Research Study Groups: Atezolizumab Placebo + Cobimetinib + Vemurafenib, Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib Placebo
Melanoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT02908672 — Phase 3
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02908672 — Phase 3

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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~64 spots leftby Feb 2025