A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab... | Not Recruiting
A Study to Investigate Efficacy and... | Not Recruiting
A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370)

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Medical Conditions
  • Colorectal Cancer
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT02788279
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
This is a Phase III, multicenter, open-label, three-arm, randomized study in participants with unresectable locally advanced or metastatic colorectal cancer (CRC) who have received at least two prior regimens of cytotoxic chemotherapy for metastatic disease. The study compares regorafenib, a standard of care therapy in this setting, to cobimetinib plus atezolizumab and atezolizumab monotherapy.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Atezolizumab (MPDL3280A), an Engineered Anti-PDL1 Antibody, Drug : Cobimetinib, Drug : Regorafenib

Study Arm Groups : Atezolizumab, Cobimetinib + Atezolizumab, Cobimetinib + Atezolizumab, Regorafenib

Intervention Type
See Interventions above
Primary Outcome Measures
    Overall Survival (OS); Baseline up to death due to any cause (up to approximately 3 years)
Secondary Outcome Measures
    Progression-Free Survival (PFS) According to RECIST Version 1.1; From randomization up to disease progression or death due to any cause (up to approximately 3 years); Percentage of Participants with Investigator-Assessed Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.1; From randomization up to disease progression or death due to any cause (up to approximately 3 years); Duration of Response (DOR) According to RECIST Version 1.1; From first occurrence of CR or PR up to disease progression or death due to any cause (up to approximately 3 years); Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life-C30 Questionnaire (EORTC QLQ-C30) Physical Functioning Sub-scale Score at the End of the Study; Baseline, end of the study (up to approximately 3 years); Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life-C30 Questionnaire (EORTC QLQ-C30) Global Quality of Life Sub-scale Score at the End of the Study; Baseline, end of the study (up to approximately 3 years); Percentage of Participants with Adverse Events (AEs); Baseline up to end of the study (up to approximately 3 years); Plasma Concentration of Cobimetinib; Predose (0 hours) and 3 to 6 hours after dose on Day 15 of Cycles 1 and 4 (1 cycle = 28 days); Serum Concentration of Atezolizumab; Pre-infusion (0 hours) on Day 1 of Cycle 1 up to approximately 3 years. Detailed time frame is explained in the outcome measure description field.; Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Atezolizumab; Pre-infusion (0 hours) on Day 1 of Cycles 1 to 4, 8, and every 8 cycles thereafter; at treatment discontinuation; 120 days after treatment discontinuation (up to approximately 3 years) (1 cycle = 28 days); EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire Score; At the end of the study (up to approximately 3 years)
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
360
Participant Inclusion Criteria
    Inclusion Criteria:

    Disease-specific inclusion criteria:

    - Histologically confirmed adenocarcinoma originating from the colon or rectum (Stage 4 American Joint Committee on Cancer [AJCC] 7th edition)

    - Experienced disease progression or was intolerant to at least two systemic chemotherapy regimens for metastatic colorectal cancer that must have included fluroropyrimidines, irinotecan, and oxaliplatin; adjuvant regimen can be considered as one chemotherapy regimen for metastatic disease if the participant had disease recurrence within 6 months of completion; disease progression must have occurred within 3 months of the last systemic therapy administration

    General inclusion criteria:

    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    - Anticipated life expectancy greater than or equal to (>=) 3 months

    - Adequate hematologic and end organ function

    - Women of childbearing potential must agree to appropriately use an effective form of contraception (failure rate of less than [<] 1 percent [%] per year) during the treatment period, within 5 months after the last dose of atezolizumab, and within 3 months after the last dose of cobimetinib and regorafenib

    - Men must agree not to donate sperm or have intercourse with a female partner without using appropriate barrier contraception during the treatment period and for 3 months after the last dose of either cobimetinib or regorafenib

    - Provide an archival or newly obtained tumor tissue sample

    Exclusion Criteria:

    - After the approximate 5% cap for microsatellite (MSI)-high participants is reached, only MSI-stable participants will be eligible

    - Once the 50% cap for wild-type RAS has been reached, only extended RAS-mutant participants will be eligible

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

    - Treatment with any anti-cancer agent within 14 days prior to Cycle 1 Day 1

    - Uncontrolled tumor-related pain. Participants requiring narcotic pain medication must be on a stable regimen at study entry

    - Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage more than once every 28 days. Indwelling drainage catheters (e.g., PleurX®) are allowed

    - Active or untreated central nervous system (CNS) metastases are excluded

    - Prior therapy with any cancer immunotherapy, MEK inhibitor, or regorafenib

    - Participants with active malignancy (other than CRC) or a prior malignancy within the past 3 years are excluded. Participants with completely resected cutaneous melanoma (early stage), basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in-situ, breast carcinoma in-situ, and localized prostate cancer are eligible

    - Unstable angina, new onset angina within last 3 months, myocardial infarction within last 6 months and current congestive heart failure New York Heart Association Class II or higher

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

    - Poorly controlled hypertension, defined as a blood pressure consistently above 150/90 millimeters of Mercury (mmHg) despite optimal medical management

    - Human immunodeficiency virus (HIV) infection

    - Active tuberculosis infection

    - Severe infections within 2 weeks prior to Cycle 1 Day 1

    - Active or chronic viral hepatitis B or C infection

    - History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for central serous retinopathy, retinal vein occlusion, or neovascular macular degeneration

    - Participants will be excluded if they currently have any of the risk factors as defined in the study protocol for retinal vein occlusion

    - History of autoimmune disease

    - History of idiopathic pulmonary fibrosis, organizing pneumonia, bronchiolitis obliterans, drug-induced pneumonitis, or idiopathic pneumonitis

    - History of organ transplantation including allogeneic bone marrow transplantation

    - Inability to swallow medications

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

    - Pregnant, lactating, breastfeeding, or intending to become pregnant during the study

    - Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation of a live attenuated vaccine will be required during the study
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
GSK Investigational Site
Bordesley Green
B9 5SS
Manchester
M20 4BX
Maidstone Hospital
Maidstone
England
ME16 9QQ
Royal Marsden - Surrey
Sutton
England
SM2 5PT
St. James University Hospital, Department of Neurology
Leeds
LS9 7TF
Romford
Essex
RM7 0AG
Oxford
OX3 7LJ
Royal Marsden Hospital - Sutton
London
England
SW3 6JJ
Sheffield
S10 2SJ
Scarborough General Hospital
Scarborough
England
YO12 6QL
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Belgium, Canada, Germany, Hong Kong, Italy, Korea, Republic of, Poland, Russian Federation, Spain, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase III, Open-Label, Multicenter, Three-Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy vs. Regorafenib in Patients With Previously Treated Unresectable Locally Advanced or Metastatic Colorectal Adenocarcinoma
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
GO30182
Sponsor(s)
Hoffmann-La Roche
Key Dates

Recruitment Start Date

Jul 2016

Recruitment End Date

Feb 2019

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

27 May 2016

Date updated in source

26 Sep 2017