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

Description

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.

Study Start Date

October, 30 2017

Estimated Completion Date

October 2024

Interventions

  • Drug: Cobimetinib
  • Drug: Pembrolizumab
  • Drug: Atezolizumab

Study ID

Hoffmann-La Roche -- CO39722

Status

Recruiting

Trial ID

NCT03273153

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

450

Sponsor

Hoffmann-La Roche

Inclusion Criteria

    Disease-Specific Inclusion Criteria
  • Histologically confirmed Stage IV (metastatic) or unresectable Stage IIIc (locally advanced) 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 participants to use an electronic device to report selected study outcomes

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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (204)

Study Location Distance Name Phone Email
Massachusetts General HospitalHematology Oncology - Boston, Massachusetts 2.8 miles None None None
Massachusetts General HospitalHematology Oncology - Boston, Massachusetts 2.8 miles None None None
Massachusetts General HospitalHematology Oncology - Boston, Massachusetts 2.8 miles None None None
Massachusetts General HospitalHematology Oncology - Boston, Massachusetts 2.8 miles None None None
Massachusetts General HospitalHematology Oncology - Boston, Massachusetts 2.8 miles None None None
Rhode Island Hospital - Providence, Rhode Island 41.0 miles None None None
Rhode Island Hospital - Providence, Rhode Island 41.0 miles None None None
Rhode Island Hospital - Providence, Rhode Island 41.0 miles None None None
DartmouthHitchcock Medical Center HematologyOncology - Lebanon, New Hampshire 105.5 miles None None None
DartmouthHitchcock Medical Center HematologyOncology - Lebanon, New Hampshire 105.5 miles None None None
DartmouthHitchcock Medical Center HematologyOncology - Lebanon, New Hampshire 105.5 miles None None None
DartmouthHitchcock Medical Center HematologyOncology - Lebanon, New Hampshire 105.5 miles None None None
DartmouthHitchcock Medical Center HematologyOncology - Lebanon, New Hampshire 105.5 miles None None None
Columbia University Medical Center - New York, New York 181.2 miles None None None
Columbia University Medical Center - New York, New York 181.2 miles None None None
Columbia University Medical Center - New York, New York 181.2 miles None None None
Columbia University Medical Center - New York, New York 181.2 miles None None None
Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles None None None
Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles None None None
Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles None None None
Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles None None None
Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles None None None
Morristown Medical Center - Morristown, New Jersey 206.3 miles None None None
Morristown Medical Center - Morristown, New Jersey 206.3 miles None None None
Morristown Medical Center - Morristown, New Jersey 206.3 miles None None None
Morristown Medical Center - Morristown, New Jersey 206.3 miles None None None
Morristown Medical Center - Morristown, New Jersey 206.3 miles None None None
St Lukes University Health network - Bethlehem, Pennsylvania 252.7 miles None None None
St Lukes University Health network - Bethlehem, Pennsylvania 252.7 miles None None None
St Lukes University Health network - Bethlehem, Pennsylvania 252.7 miles None None None
St Lukes University Health network - Bethlehem, Pennsylvania 252.7 miles None None None
St Lukes University Health network - Bethlehem, Pennsylvania 252.7 miles None None None
Thomas Jefferson University HospitalMedical Oncology - Philadelphia, Pennsylvania 269.5 miles None None None
Thomas Jefferson University HospitalMedical Oncology - Philadelphia, Pennsylvania 269.5 miles None None None
Thomas Jefferson University HospitalMedical Oncology - Philadelphia, Pennsylvania 269.5 miles None None None
Thomas Jefferson University HospitalMedical Oncology - Philadelphia, Pennsylvania 269.5 miles None None None
Thomas Jefferson University HospitalMedical Oncology - Philadelphia, Pennsylvania 269.5 miles None None None
Hillman Cancer CenterMedical Oncology - Pittsburgh, Pennsylvania 477.2 miles None None None
Hillman Cancer CenterMedical Oncology - Pittsburgh, Pennsylvania 477.2 miles None None None
Hillman Cancer CenterMedical Oncology - Pittsburgh, Pennsylvania 477.2 miles None None None
Hillman Cancer CenterMedical Oncology - Pittsburgh, Pennsylvania 477.2 miles None None None
Hillman Cancer CenterMedical Oncology - Pittsburgh, Pennsylvania 477.2 miles None None None
Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
University of Michigan Comprehensive Cancer Center Clinical Trials Office - Ann Arbor, Michigan 645.2 miles None None None
University of Michigan Comprehensive Cancer Center Clinical Trials Office - Ann Arbor, Michigan 645.2 miles None None None
University of Michigan Comprehensive Cancer Center Clinical Trials Office - Ann Arbor, Michigan 645.2 miles None None None
University of Michigan Comprehensive Cancer Center Clinical Trials Office - Ann Arbor, Michigan 645.2 miles None None None
University of Michigan Comprehensive Cancer Center Clinical Trials Office - Ann Arbor, Michigan 645.2 miles None None None
Forsythe Memorial Hospital Inc dba Novant Health Oncology Specialists - Winston-Salem, North Carolina 659.2 miles None None None
Forsythe Memorial Hospital Inc dba Novant Health Oncology Specialists - Winston-Salem, North Carolina 659.2 miles None None None
Forsythe Memorial Hospital Inc dba Novant Health Oncology Specialists - Winston-Salem, North Carolina 659.2 miles None None None
Forsythe Memorial Hospital Inc dba Novant Health Oncology Specialists - Winston-Salem, North Carolina 659.2 miles None None None
Forsythe Memorial Hospital Inc dba Novant Health Oncology Specialists - Winston-Salem, North Carolina 659.2 miles None None None
Parkview Physicians Group - Fort Wayne, Indiana 727.2 miles None None None
Parkview Physicians Group - Fort Wayne, Indiana 727.2 miles None None None
Parkview Physicians Group - Fort Wayne, Indiana 727.2 miles None None None
Parkview Physicians Group - Fort Wayne, Indiana 727.2 miles None None None
Parkview Physicians Group - Fort Wayne, Indiana 727.2 miles None None None
TriHealth Hatton Institute Surgical Education - Cincinnati, Ohio 737.4 miles None None None
TriHealth Hatton Institute Surgical Education - Cincinnati, Ohio 737.4 miles None None None
TriHealth Hatton Institute Surgical Education - Cincinnati, Ohio 737.4 miles None None None
TriHealth Hatton Institute Surgical Education - Cincinnati, Ohio 737.4 miles None None None
TriHealth Hatton Institute Surgical Education - Cincinnati, Ohio 737.4 miles None None None
UC Health Clinical Trials Office Division of HematologyOncology - Cincinnati, Ohio 737.6 miles None None None
UC Health Clinical Trials Office Division of HematologyOncology - Cincinnati, Ohio 737.6 miles None None None
UC Health Clinical Trials Office Division of HematologyOncology - Cincinnati, Ohio 737.6 miles None None None
UC Health Clinical Trials Office Division of HematologyOncology - Cincinnati, Ohio 737.6 miles None None None
UC Health Clinical Trials Office Division of HematologyOncology - Cincinnati, Ohio 737.6 miles None None None
Medical University of South Carolina - Charleston, South Carolina 821.2 miles None None None
Medical University of South Carolina - Charleston, South Carolina 821.2 miles None None None
Northwestern University - Chicago, Illinois 847.9 miles None None None
Northwestern University - Chicago, Illinois 847.9 miles None None None
Northwestern University - Chicago, Illinois 847.9 miles None None None
Northwestern University - Chicago, Illinois 847.9 miles None None None
Northwestern University - Chicago, Illinois 847.9 miles None None None
Oncology Specialists SC - Niles, Illinois 856.2 miles None None None
Oncology Specialists SC - Niles, Illinois 856.2 miles None None None
Oncology Specialists SC - Niles, Illinois 856.2 miles None None None
Oncology Specialists SC - Niles, Illinois 856.2 miles None None None
Oncology Specialists SC - Niles, Illinois 856.2 miles None None None
SCRI Tennessee Oncology Chattanooga - Chattanooga, Tennessee 917.3 miles None None None
SCRI Tennessee Oncology Chattanooga - Chattanooga, Tennessee 917.3 miles None None None
SCRI Tennessee Oncology Chattanooga - Chattanooga, Tennessee 917.3 miles None None None
Sarah Cannon Research Institute - Nashville, Tennessee 942.8 miles None None None
Sarah Cannon Research Institute - Nashville, Tennessee 942.8 miles None None None
Sarah Cannon Research Institute - Nashville, Tennessee 942.8 miles None None None
Vanderbilt University Medical Center Vanderbilt University - Nashville, Tennessee 944.2 miles None None None
Vanderbilt University Medical Center Vanderbilt University - Nashville, Tennessee 944.2 miles None None None
Vanderbilt University Medical Center Vanderbilt University - Nashville, Tennessee 944.2 miles None None None
Vanderbilt University Medical Center Vanderbilt University - Nashville, Tennessee 944.2 miles None None None
Vanderbilt University Medical Center Vanderbilt University - Nashville, Tennessee 944.2 miles None None None
SCRI Florida Cancer Specialists PAN - Tallahassee, Florida 1,096.9 miles None None None
SCRI Florida Cancer Specialists PAN - Tallahassee, Florida 1,096.9 miles None None None
SCRI Florida Cancer Specialists PAN - Tallahassee, Florida 1,096.9 miles None None None
SCRI Florida Cancer Specialists PAN - Tallahassee, Florida 1,096.9 miles None None None
SCRI Florida Cancer Specialists PAN - Tallahassee, Florida 1,096.9 miles None None None
Minnesota Oncology Edina - Edina, Minnesota 1,125.1 miles None None None
Minnesota Oncology Edina - Edina, Minnesota 1,125.1 miles None None None
Minnesota Oncology Edina - Edina, Minnesota 1,125.1 miles None None None
Minnesota Oncology Edina - Edina, Minnesota 1,125.1 miles None None None
Minnesota Oncology Edina - Edina, Minnesota 1,125.1 miles None None None
UF Health Cancer Center at Orlando Health - Orlando, Florida 1,125.5 miles None None None
UF Health Cancer Center at Orlando Health - Orlando, Florida 1,125.5 miles None None None
UF Health Cancer Center at Orlando Health - Orlando, Florida 1,125.5 miles None None None
UF Health Cancer Center at Orlando Health - Orlando, Florida 1,125.5 miles None None None
UF Health Cancer Center at Orlando Health - Orlando, Florida 1,125.5 miles None None None
Moffitt Cancer Center - Tampa, Florida 1,178.7 miles None None None
Moffitt Cancer Center - Tampa, Florida 1,178.7 miles None None None
Moffitt Cancer Center - Tampa, Florida 1,178.7 miles None None None
Moffitt Cancer Center - Tampa, Florida 1,178.7 miles None None None
Moffitt Cancer Center - Tampa, Florida 1,178.7 miles None None None
Florida Cancer Specialists - West Palm Beach, Florida 1,197.4 miles None None None
Florida Cancer Specialists - West Palm Beach, Florida 1,197.4 miles None None None
Florida Cancer Specialists - West Palm Beach, Florida 1,197.4 miles None None None
Florida Cancer Specialists - West Palm Beach, Florida 1,197.4 miles None None None
Florida Cancer Specialists - West Palm Beach, Florida 1,197.4 miles None None None
Florida Cancer Specialist North Region - Saint Petersburg, Florida 1,203.3 miles None None None
Florida Cancer Specialist North Region - Saint Petersburg, Florida 1,203.3 miles None None None
Florida Cancer Specialist North Region - Saint Petersburg, Florida 1,203.3 miles None None None
Florida Cancer Specialist North Region - Saint Petersburg, Florida 1,203.3 miles None None None
Florida Cancer Specialist North Region - Saint Petersburg, Florida 1,203.3 miles None None None
University of South Alabama Mitchell Cancer Institute - Mobile, Alabama 1,239.6 miles None None None
University of South Alabama Mitchell Cancer Institute - Mobile, Alabama 1,239.6 miles None None None
University of South Alabama Mitchell Cancer Institute - Mobile, Alabama 1,239.6 miles None None None
University of South Alabama Mitchell Cancer Institute - Mobile, Alabama 1,239.6 miles None None None
University of South Alabama Mitchell Cancer Institute - Mobile, Alabama 1,239.6 miles None None None
Memorial Healthcare System Office of Human Research - Hollywood, Florida 1,244.0 miles None None None
Memorial Healthcare System Office of Human Research - Hollywood, Florida 1,244.0 miles None None None
Memorial Healthcare System Office of Human Research - Hollywood, Florida 1,244.0 miles None None None
Memorial Healthcare System Office of Human Research - Hollywood, Florida 1,244.0 miles None None None
Memorial Healthcare System Office of Human Research - Hollywood, Florida 1,244.0 miles None None None
Mount Sinai Medical Center - Miami Beach, Florida 1,256.3 miles None None None
Mount Sinai Medical Center - Miami Beach, Florida 1,256.3 miles None None None
Mount Sinai Medical Center - Miami Beach, Florida 1,256.3 miles None None None
Mount Sinai Medical Center - Miami Beach, Florida 1,256.3 miles None None None
Mount Sinai Medical Center - Miami Beach, Florida 1,256.3 miles None None None
Highlands Oncology Group - Rogers, Arkansas 1,297.4 miles None None None
Baylor University Medical Center - Dallas, Texas 1,549.9 miles None None None
Baylor University Medical Center - Dallas, Texas 1,549.9 miles None None None
Baylor University Medical Center - Dallas, Texas 1,549.9 miles None None None
Baylor University Medical Center - Dallas, Texas 1,549.9 miles None None None
Baylor University Medical Center - Dallas, Texas 1,549.9 miles None None None
Texas Oncology PA Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Texas Oncology PA Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Texas Oncology PA Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Texas Oncology PA Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Texas Oncology PA Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Texas OncCentral Austin CA Ct - Austin, Texas 1,694.2 miles None None None
Texas OncCentral Austin CA Ct - Austin, Texas 1,694.2 miles None None None
Texas OncCentral Austin CA Ct - Austin, Texas 1,694.2 miles None None None
Texas OncCentral Austin CA Ct - Austin, Texas 1,694.2 miles None None None
Texas OncCentral Austin CA Ct - Austin, Texas 1,694.2 miles None None None
Univ of Colorado - Aurora, Colorado 1,759.8 miles None None None
Univ of Colorado - Aurora, Colorado 1,759.8 miles None None None
Univ of Colorado - Aurora, Colorado 1,759.8 miles None None None
Univ of Colorado - Aurora, Colorado 1,759.8 miles None None None
Univ of Colorado - Aurora, Colorado 1,759.8 miles None None None
Rocky Mountain Cancer Center Aurora - Aurora, Colorado 1,760.5 miles None None None
Rocky Mountain Cancer Center Aurora - Aurora, Colorado 1,760.5 miles None None None
Rocky Mountain Cancer Center Aurora - Aurora, Colorado 1,760.5 miles None None None
Rocky Mountain Cancer Center Aurora - Aurora, Colorado 1,760.5 miles None None None
Rocky Mountain Cancer Center Aurora - Aurora, Colorado 1,760.5 miles None None None
Huntsman Cancer Institute at The University of Utah - Salt Lake City, Utah 2,094.1 miles None None None
Huntsman Cancer Institute at The University of Utah - Salt Lake City, Utah 2,094.1 miles None None None
Huntsman Cancer Institute at The University of Utah - Salt Lake City, Utah 2,094.1 miles None None None
Huntsman Cancer Institute at The University of Utah - Salt Lake City, Utah 2,094.1 miles None None None
Huntsman Cancer Institute at The University of Utah - Salt Lake City, Utah 2,094.1 miles None None None
University of Arizona Cancer Center - Tucson, Arizona 2,281.2 miles None None None
Arizona Oncology Associates PC HAL - Chandler, Arizona 2,292.9 miles None None None
Arizona Oncology Associates PC HAL - Chandler, Arizona 2,292.9 miles None None None
Arizona Oncology Associates PC HAL - Chandler, Arizona 2,292.9 miles None None None
Arizona Oncology Associates PC HAL - Chandler, Arizona 2,292.9 miles None None None
Arizona Oncology Associates PC HAL - Chandler, Arizona 2,292.9 miles None None None
City of Hope Comprehensive Cancer Center - Duarte, California 2,578.2 miles None None None
University of California at Irvine Medical Center Department of Oncology - Orange, California 2,585.0 miles None None None
University of California at Irvine Medical Center Department of Oncology - Orange, California 2,585.0 miles None None None
University of California at Irvine Medical Center Department of Oncology - Orange, California 2,585.0 miles None None None
University of California at Irvine Medical Center Department of Oncology - Orange, California 2,585.0 miles None None None
University of California at Irvine Medical Center Department of Oncology - Orange, California 2,585.0 miles None None None
USC Norris Cancer Center - Los Angeles, California 2,593.7 miles None None None
USC Norris Cancer Center - Los Angeles, California 2,593.7 miles None None None
USC Norris Cancer Center - Los Angeles, California 2,593.7 miles None None None
The Angeles Clinic and Research Institute W LA Office - Los Angeles, California 2,606.1 miles None None None
The Angeles Clinic and Research Institute W LA Office - Los Angeles, California 2,606.1 miles None None None
The Angeles Clinic and Research Institute W LA Office - Los Angeles, California 2,606.1 miles None None None
The Angeles Clinic and Research Institute W LA Office - Los Angeles, California 2,606.1 miles None None None
The Angeles Clinic and Research Institute W LA Office - Los Angeles, California 2,606.1 miles None None None
UC Davis Cancer Center Oncology - Sacramento, California 2,628.4 miles None None None
UC Davis Cancer Center Oncology - Sacramento, California 2,628.4 miles None None None
UC Davis Cancer Center Oncology - Sacramento, California 2,628.4 miles None None None
UC Davis Cancer Center Oncology - Sacramento, California 2,628.4 miles None None None
UC Davis Cancer Center Oncology - Sacramento, California 2,628.4 miles None None None
Stanford Comprehensive Cancer Center - Stanford, California 2,694.5 miles None None None
Stanford Comprehensive Cancer Center - Stanford, California 2,694.5 miles None None None
Stanford Comprehensive Cancer Center - Stanford, California 2,694.5 miles None None None
California Pacific Medical Center Research Institute - San Francisco, California 2,698.0 miles None None None
California Pacific Medical Center Research Institute - San Francisco, California 2,698.0 miles None None None
California Pacific Medical Center Research Institute - San Francisco, California 2,698.0 miles None None None
St Marys Medical Center - San Francisco, California 2,701.0 miles None None None
St Marys Medical Center - San Francisco, California 2,701.0 miles None None None
St Marys Medical Center - San Francisco, California 2,701.0 miles None None None
St Marys Medical Center - San Francisco, California 2,701.0 miles None None None
St Marys Medical Center - San Francisco, California 2,701.0 miles None None None

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