AzTrials
AzTrials

Colorectal CancerPhase 3NCT02788279

A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370)

A Phase 3 study testing Atezolizumab (MPDL3280A), an Engineered Anti-PDL1 Antibody, Cobimetinib and Regorafenib in people with Colorectal Cancer, run by Hoffmann-La Roche at 73 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Atezolizumab (MPDL3280A), an Engineered Anti-PDL1 Antibody, Cobimetinib and Regorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
363 participants
Where
73 sitesin 11 countries
Study dates
5 Jul 2016to 26 Dec 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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

Trial locations and contacts

73 sites in 11 countries.

73 sites in 11 countries

United States17 sites

  • SCRI Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • North Shore Hem Onc Associates

    East Setauket, New York, 11733

  • Southdale Cancer Clinic U of M Medical Center, Fairview- Edina

    Edina, Minnesota, 55435

  • Florida Cancer Specialists; SCRI

    Fort Myers, Florida, 33901

  • Ingalls Cancer Research Center

    Harvey, Illinois, 60426

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

    Jacksonville, Florida, 32256

  • Sarah Cannon Research Inst.

    Nashville, Tennessee, 37203

  • Yale Cancer Center; Medical Oncology

    New Haven, Connecticut, 06520

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • INTEGRIS Cancer Inst of OK

    Oklahoma City, Oklahoma, 73142

  • University of Pittsburgh Cancer Institute; Division of Medical Oncology

    Pittsburgh, Pennsylvania, 15232

  • Medical Oncology Associates

    Spokane, Washington, 99208

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Florida Cancer Specialists.

    St. Petersburg, Florida, 33705

  • Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

Canada8 sites

  • Tom Baker Cancer Centre-Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute; Clinical Trials

    Edmonton, Alberta, T6G 1Z2

  • McGill University Health Center, Cedar Cancer Center

    Montreal, Quebec, H3G 1A4

  • Hopital du Sacre-Coeur

    Montreal, Quebec, J4B 5Z7

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • CHU de Québec

    Québec, Quebec, G1J 1Z4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Italy7 sites

  • Istit. Naz. per la Ricerca sul Cancro - Az. Osped. S. Martino

    Genoa, Liguria, 16132

  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

    Milan, Lombardy, 20133

  • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

    Milan, Lombardy, 20162

  • A.O. Universitaria Policlinico Di Modena; Oncologia

    Modena, Emilia-Romagna, 41100

  • Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica

    Naples, Campania, 80131

  • A.O. Universitaria Pisana; Oncologia

    Pisa, Tuscany, 56100

  • IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

    San Giovanni Rotondo, Apulia, 71013

Other trials in Italy

United Kingdom7 sites

  • Birmingham Heartlands Hospital; Dept of Oncology

    Birmingham, B9 5SS

  • Royal Marsden Hospital - Fulham; Oncology Department

    London, SW3 6JJ

  • The Christie; GI Research Office

    Manchester, M20 4BX

  • Churchill Hospital; Department of Oncology

    Oxford, OX3 7LE

  • Queen's Hospital

    Romford, RM7 0AG

  • Weston Park Hospital; Cancer Clinical Trials Centre

    Sheffield, S10 2SJ

  • Royal Marsden Hospital; Dept of Medical Oncology

    Sutton, SM2 5PT

Other trials in United Kingdom

Australia6 sites

  • Monash Medical Centre; Oncology

    Clayton, Victoria, 3168

  • Peninsula and South Eastern Haematology and Oncology Group

    Frankston, Victoria, 3199

  • Austin Health; Cancer Clinical Trial Centre

    Heidelberg, Victoria, 3084

  • Port Macquarie Base Hospital;North Coast Cancer Institute

    Port Macquarie, New South Wales, 2444

  • Northern Cancer Institute

    St Leonards, New South Wales, 2065

  • Sydney Adventist Hospital; Clinical Trial Unit

    Sydney, New South Wales, 2076

Other trials in Australia

South Korea6 sites

  • National Cancer Center

    Gyeonggi-do, 10408

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center - Oncology

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Yonsei University Health System/Severance Hospital

    Seoul, 120-752

Other trials in South Korea

Spain6 sites

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, 08035

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • Hospital Clinico San Carlos; Servicio de Oncologia

    Madrid, 28040

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Hospital de Navarra; Servicio de Oncologia

    Navarra, Navarre, 31008

  • Hospital Clínico Universitario de Valencia; Servicio de Oncología

    Valencia, 46010

Other trials in Spain

Belgium5 sites

  • Imeldaziekenhuis

    Bonheiden, 2820

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • GHdC Site Notre Dame

    Charleroi, 6000

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Poland5 sites

  • Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85-796

  • Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

    Gdansk, 80-214

  • Szpitale Pomorskie Sp. z o. o.

    Gdynia, 81-519

  • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

    Krakow, 31-531

  • Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii

    Lodz, 93-513

Other trials in Poland

Hong Kong3 sites

  • Queen Mary Hospital; Dept. of Clinical Oncology

    Hong Kong

  • Tuen Mun Hospital; Clinical Oncology

    Hong Kong

  • Prince of Wales Hosp; Dept. Of Clinical Onc

    Shatin

Other trials in Hong Kong

Russia3 sites

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, 163045

  • N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

    Moscow, 105229

  • BHI of Omsk region Clinical Oncology Dispensary

    Omsk, 644013

Other trials in Russia

About this study

Official 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

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.

Being tested
Atezolizumab (MPDL3280A), an Engineered Anti-PDL1 Antibody, Cobimetinib, Regorafenib
Keywords
Locally advanced or Metastatic colorectal adenocarcinoma
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atezolizumab (MPDL3280A), an Engineered Anti-PDL1 AntibodyDrug

    Participants will receive atezolizumab IV at 840 mg on Day 1 and Day 15 in a 28-day cycle as a combination therapy or at 1200 mg on Day 1 in a 21-day cycle as a monotherapy until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.

  • CobimetinibDrug

    Participants will receive cobimetinib 60 mg orally on Days 1 to 21 in a 28-day cycle as a combination therapy until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.

  • RegorafenibDrug

    Participants will receive regorafenib 160 mg orally on Days 1 to 21 in a 28-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.

Study groups in NCT02788279
Study groupRoleWhat they receive
AtezolizumabExperimentalParticipants will receive atezolizumab monotherapy 1200 milligrams (mg) intravenous (IV) on Day 1 in a 21-day cycle until disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
Receives: Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PDL1 Antibody
Cobimetinib + AtezolizumabExperimentalParticipants will receive cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 in a 28-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
Receives: Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PDL1 Antibody; Drug: Cobimetinib
RegorafenibActive comparatorParticipants will receive regorafenib 160 mg orally on Days 1 to 21 in a 28-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
Receives: Drug: Regorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall survival is defined as the time (in months) between the date of randomization and the date of death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.

    Measured: From randomization up to death due to any cause (up to approximately 20 months)

Secondary outcomes (9)

  1. Progression-Free Survival (PFS) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.

    Measured: From randomization up to disease progression or death due to any cause (up to approximately 20 months)

  2. Percentage of Participants With Investigator-Assessed Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.1

    PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Objective response and its 95% CI were calculated using the Clopper-Pearson method.

    Measured: From randomization up to death due to any cause (up to approximately 20 months)

  3. Duration of Response (DOR) According to RECIST Version 1.1

    DOR is defined as the period measured from the date of the first occurrence of a CR or PR (whichever status is recorded first) until the first date that progressive disease or death is documented. Disease progression was determined on the basis of investigator assessment with use of RECIST v1.1. Median DOR was estimated using the Kaplan-Meier method, and the 95% CI was calculated using the method of Brookmeyer and Crowley.

    Measured: From first occurrence of CR or PR up to disease progression or death due to any cause (up to approximately 20 months)

  4. 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

    The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.

    Measured: Baseline, end of the study (up to approximately 2.5 years)

  5. 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

    The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.

    Measured: Baseline, end of the study (up to approximately 2.5 years)

  6. Percentage of Participants With Adverse Events (AEs)

    Measured: Baseline, end of the study (up to approximately 2.5 years)

  7. Plasma Concentration of Cobimetinib

    Measured: Predose (0 hours) and 3 to 6 hours after dose on Day 15 of Cycles 1 and 4 (1 cycle = 28 days) (up to approximately 2.5 years).

  8. Serum Concentration of Atezolizumab

    Pre-infusion (0 hours) on Day 1 of Cycles 1 to 4; 30 minutes post-infusion on Day 1 of Cycles 1 and 4; pre-infusion (0 hours) on Day 1 of Cycle 8 and every 8 cycles thereafter; at treatment discontinuation; 120 days after treatment discontinuation (up to approximately 2.5 years) (1 cycle = 28 days)

    Measured: Pre-infusion (0 hours) on Day 1 of Cycle 1 up to approximately 2.5 years. Detailed time frame is explained in the outcome measure description field.

  9. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab

    Measured: 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 2.5 years) (1 cycle = 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2016 (estimated)
  2. Study start5 Jul 2016
  3. Primary completion9 Mar 2018
  4. Study completion26 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
363 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02788279
Sponsor's protocol ID
GO30182
Other IDs
2016-000202-11, 2016
Status last verified
Nov 2019
First submitted
27 May 2016
Last updated
11 Dec 2019

Publications

  • Taraborrelli L, Senbabaoglu Y, Wang L, Lim J, Blake K, Kljavin N, Gierke S, Scherl A, Ziai J, McNamara E, Owyong M, Rao S, Calviello AK, Oreper D, Jhunjhunwala S, Argiles G, Bendell J, Kim TW, Ciardiello F, Wongchenko MJ, de Sauvage FJ, de Sousa E Melo F, Yan Y, West NR, Murthy A. Tumor-intrinsic expression of the autophagy gene Atg16l1 suppresses anti-tumor immunity in colorectal cancer. Nat Commun. 2023 Sep 23;14(1):5945. doi: 10.1038/s41467-023-41618-7.

    PubMed 37741832

  • Barteselli G, Goodman GR, Patel Y, Caro I, Xue C, McCallum S. Characterization of Serous Retinopathy Associated with Cobimetinib: Integrated Safety Analysis of Four Studies. Drug Saf. 2022 Dec;45(12):1491-1499. doi: 10.1007/s40264-022-01248-2. Epub 2022 Oct 30.

    PubMed 36310331

  • Eng C, Kim TW, Bendell J, Argiles G, Tebbutt NC, Di Bartolomeo M, Falcone A, Fakih M, Kozloff M, Segal NH, Sobrero A, Yan Y, Chang I, Uyei A, Roberts L, Ciardiello F; IMblaze370 Investigators. Atezolizumab with or without cobimetinib versus regorafenib in previously treated metastatic colorectal cancer (IMblaze370): a multicentre, open-label, phase 3, randomised, controlled trial. Lancet Oncol. 2019 Jun;20(6):849-861. doi: 10.1016/S1470-2045(19)30027-0. Epub 2019 Apr 16.

    PubMed 31003911

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab (MPDL3280A), an Engineered Anti-PDL1 Antibody, Cobimetinib and Regorafenib in people with Colorectal Cancer, run by Hoffmann-La Roche at 73 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Canada, Italy, United Kingdom, Australia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From randomization up to death due to any cause (up to approximately 20 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02788279, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.

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