A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:December 11, 2017
End Date:September 17, 2024
Contact:Reference Study ID Number: CO39722 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:+1 888-662-6728

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A Phase III, Open-Label, Multicenter, Two Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced BRAF V600 Wild-Type Melanoma

This is a Phase III, multicenter, open-label, randomized study designed to evaluate the
efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with
pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma.


Inclusion Criteria:

Disease-Specific Inclusion Criteria

- Histologically confirmed locally advanced and unresectable or metastatic melanoma

- Naive to prior systemic anti-cancer therapy for melanoma

- Documentation of BRAFV600 wild-type status in melanoma tumor tissue through use of a
clinical mutation test approved by the local health authority

- A representative, formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a
paraffin block (preferred) or 20 slides containing unstained, freshly cut, serial
sections must be submitted along with an associated pathology report prior to study
entry. If 20 slides are not available or the tissue block is not of sufficient size,
the patient may still be eligible for the study, after discussion with and approval by
the Medical Monitor

- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
v1.1

- Age >=18 years at time of signing Informed Consent Form

- Ability to comply with the study protocol, in the investigator's judgment

- Histologically or cytologically confirmed BRAFV600 wild-type melanoma

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Life expectancy >=3 months

- Adequate hematologic and end-organ function

- For women of childbearing potential: agreement to remain abstinent or use at least two
forms of effective contraceptive with a failure rate of < 1% per year during the
treatment period and for at least 3 months after the last dose of cobimetinib and at
least 5 months after the last dose of atezolizumab or pembrolizumab

- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
contraceptive measures (e.g. condom), and agreement to refrain from donating sperm,
for at least 3 months after the last dose of cobimetinib

- Willingness and ability of patients to report selected study outcomes (e.g., GHS and
HRQoL) using an electronic device or paper backup questionnaires.

Exclusion Criteria:

General Exclusion Criteria

- Inability to swallow medications

- Malabsorption condition that would alter the absorption of orally administered
medications

- Pregnancy, breastfeeding, or intention of becoming pregnant during the study

- History of severe hypersensitivity reactions to components of the cobimetinib,
atezolizumab, or pembrolizumab formulations

- Current or recent treatment with therapeutic antibiotics, live attenuated vaccines or
systemic immunostimulatory/immunosuppresive medication

- Any serious medical condition or abnormality in clinical laboratory tests that, in the
investigator's judgment, precludes the patient's safe participation in and completion
of the study Cancer-Related Exclusion Criteria

- Ocular melanoma

- Major surgery or radiotherapy within 21 days prior to Day 1 of Cycle 1 or anticipation
of needing such procedure while receiving study treatment

- Uncontrolled tumor-related pain

- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated
drainage more than once every 28 days

- Active or untreated central nervous system (CNS) metastases Exclusions Related to
Cardiovascular Disease

- Unstable angina, new-onset angina within last 3 months, myocardial infarction within
the last 6 months prior to Day 1 of Cycle 1, or current congestive heart failure
classified as New York Heart Association Class II or higher

- Left ventricular ejection fraction (LVEF) below institutional lower limit of normal or
<50%, whichever is lower

- Poorly controlled hypertension, defined as sustained, uncontrolled, non-episodic
baseline hypertension consistently above 159/99 mmHg despite optimal medical
management

- History or presence of an abnormal electrocardiogram (ECG) that is clinically
significant in the investigator's opinion, including complete left bundle branch
block, second- or third degree heart block, or evidence of prior myocardial infarction
Exclusions Related to Infections

- HIV infection

- Active tuberculosis infection

- Severe infections within 4 weeks prior to Day 1 of Cycle 1, including, but not limited
to, hospitalization for complications of infection, bacteremia, or severe pneumonia

- Signs or symptoms of clinically relevant infection within 2 weeks prior to Day 1 of
Cycle 1

- Treatment with oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1

- Active or chronic viral hepatitis B or C infection Exclusions Related to Ocular
Disease

- Known risk factors for ocular toxicity Exclusions Related to Autoimmune Conditions and
Immunomodulatory Drugs

- Active or history of autoimmune disease or immune deficiency

- Prior allogeneic stem cell or solid organ transplantation

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced or
idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan

- Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1,
Cycle 1 Exclusions Related to Other Medical Conditions or Medications

- Active malignancy (other than melanoma) or a prior malignancy within the past 3 years

- Any Grade >=3 hemorrhage or bleeding event within 28 days of Day 1 of Cycle 1

- History of stroke, reversible ischemic neurological defect, or transient ischemic
attack within 6 months prior to Day 1

- Proteinuria >3.5 gm/24 hr

- Consumption of foods, supplements, or drugs that are strong or moderate CYP3A4 enzyme
inducers or inhibitors at least 7 days prior to Day 1 of Cycle 1 and during study
treatment
We found this trial at
57
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Tampa, Florida 33612
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Aurora, Colorado 80012
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Aurora, Colorado 80045
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6204 Balcones Drive
Austin, Texas 78731
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Bethlehem, Pennsylvania
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55 Fruit Street
Boston, Massachusetts 02114
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450 Brookline Avenue
Boston, Massachusetts 02215
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Cairns, Queensland
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Chandler, Arizona 85224
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Chattanooga, Tennessee 37404
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303 East Superior Street
Chicago, Illinois 60611
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375 Dixmyth Ave
Cincinnati, Ohio 45220
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Cleveland, Ohio 44111
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11123 Parkview Plaza Drive
Fort Wayne, Indiana 46845
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Fort Worth, Texas 76104
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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3501 Johnson Street
Hollywood, Florida 33021
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1515 Holcombe Boulevard
Houston, Texas 77030
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44151 15th Street West
Lancaster, California 93534
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1 Medical Center Drive
Lebanon, New Hampshire 03756
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11818 Wilshire Boulevard
Los Angeles, California 90025
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Los Angeles, California 90033
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6780 Mayfield Rd
Mayfield Heights, Ohio 44124
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Miami Beach, Florida 33140
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910 East 26th Street
Minneapolis, Minnesota 55404
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1660 Springhill Avenue
Mobile, Alabama 36604
(251) 665-8000
University of South Alabama Mitchell Cancer Institute USA Mitchell Cancer Institute (MCI) is located in...
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1 Medical Center Drive
Morgantown, West Virginia 26506
304-598-4800
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Morristown, New Jersey 07962
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
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1215 21st Avenue South
Nashville, Tennessee 37232
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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520 Superior Avenue
Newport Beach, California 92663
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Niles, Illinois 60714
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101 The City Drive South
Orange, California 92868
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801 North Flamingo Road
Pembroke Pines, Florida 33028
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925 Chestnut Street
Philadelphia, Pennsylvania 19107
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5115 Centre Avenue
Pittsburgh, Pennsylvania 15232
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Rogers, Arkansas 72758
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4501 X Street
Sacramento, California 95817
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1201 5th Avenue North
Saint Petersburg, Florida 33705
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
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Stanford, California 94305
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Tucson, Arizona 85724
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West Palm Beach, Florida 33401
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3333 Silas Creek Parkway
Winston-Salem, North Carolina 27103
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