A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC)

NCT02291289 | Completed Phase 2 Results DMC

• 2 other identifiers: MO291122014-001017-61
• Study Type: interventional
• Target: 1,044
• Locations: 21 countries
• Sites: 151

Brief Summary

This randomized, multi-center, active-controlled, open-label, parallel-group study will investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line mCRC. Participants with mCRC are eligible for entry and cannot have received any prior chemotherapy in the metastatic setting. The entire study duration is anticipated to be approximately 7.5 years.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS is defined as the time from randomization to the first occurrence of disease progression according to RECIST v1.1, or death from any cause, whichever occurs first. Progressive disease (PD) for target lesion: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/=5 mm. PD for non-target lesion: Unequivocal progression of existing non-target lesions.

  From randomization until disease progression or death from any cause, up to 5 years

Secondary Outcomes (7)

• Overall Survival (OS)

  From randomization until death from any cause, up to 5 years

• Percentage of Participants With Adverse Events

  From baseline until end of study (up to 5 years)

• Overall Response

  From randomization until disease progression, up to 5 years

• Disease Control Rate (DCR)

  From randomization until disease progression, up to 5 years

• Time to Treatment Response

  From randomization until disease progression or death from any cause, up to 5 years

Study Arms (13)

Cohort 1: Induction Phase (IP)

OTHER

Includes participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt). All participants will receive either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab.

Drug: FOLFOX induction regimen; Drug: Bevacizumab; Drug: 5-FU/LV

Cohort 2 (IP)

OTHER

Includes participants with BRAFwt. All participants will receive either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab.

Drug: FOLFOX induction regimen; Drug: Bevacizumab; Drug: 5-FU/LV

Cohort 3 (IP)

OTHER

Includes participants with human epidermal growth factor receptor 2 positive (HER2+). All participants will receive either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab.

Drug: FOLFOX induction regimen; Drug: Bevacizumab; Drug: 5-FU/LV

Cohort 4 (IP)

OTHER

Includes participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut). All participants will receive either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab.

Drug: FOLFOX induction regimen; Drug: Bevacizumab; Drug: 5-FU/LV

Cohort 1 (Maintenance Phase[MP]):5-FU/LV,cetuximab,vemurafenib

EXPERIMENTAL

Participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt) will receive 1600-2400 milligrams per square meter (mg/m\^2) 5-FU via 46-hour intravenous (IV) infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle with 500 mg/m\^2 cetuximab via infusion on Day 1 of every 2-week cycle and 960 milligrams (mg) vemurafenib twice daily (BID) by mouth.

Drug: Cetuximab; Drug: Vemurafenib; Drug: 5-FU/LV

Cohort 1 Control (MP): 5-FU/LV or capecitabin, bevacizumab

ACTIVE COMPARATOR

Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.

Drug: Fluoropyrimidine (5-FU/LV or capecitabine); Drug: Bevacizumab

Cohort 2 (MP):5-FU/LV or capecitabine,bevacizumab,atezolizumab

EXPERIMENTAL

Participants with BRAFwt will receive fluoropyrimidine (1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle.

Drug: Fluoropyrimidine (5-FU/LV or capecitabine); Drug: Atezolizumab; Drug: Bevacizumab

Cohort 2 Control (MP): 5-FU/LV or capecitabin, bevacizumab

ACTIVE COMPARATOR

Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.

Drug: Fluoropyrimidine (5-FU/LV or capecitabine); Drug: Bevacizumab

Cohort 3 (MP): capecitabine,trastuzumab,pertuzumab

EXPERIMENTAL

Participants with human epidermal growth factor receptor 2 positive (HER2+) will receive 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break with trastuzumab by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses, and pertuzumab by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses.

Drug: Trastuzumab; Drug: Pertuzumab; Drug: Capecitabine

Cohort 3 Control (MP): 5-FU/LV or capecitabin, bevacizumab

ACTIVE COMPARATOR

Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.

Drug: Fluoropyrimidine (5-FU/LV or capecitabine); Drug: Bevacizumab

Cohort 4 (MP): Cobimetinib,atezolizumab

EXPERIMENTAL

Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) will receive 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.

Drug: Atezolizumab; Drug: Cobimetinib

Cohort 4 Control (MP): 5-FU/LV or capecitabin, bevacizumab

ACTIVE COMPARATOR

Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.

Drug: Fluoropyrimidine (5-FU/LV or capecitabine); Drug: Bevacizumab

Early Progressing BRAFmut Cohort

OTHER

BRAFmut participants experiencing early disease progression during induction treatment will have the option of proceeding immediately to receive second-line treatment with 5-FU/LV, cetuximab and vemurafenib if their primary tumor is MSS, or with a fluoropyrimidine (5-FU/LV or capecitabine), bevacizumab, and atezolizumab if their primary tumor is MSI-H. This cohort will be followed for adverse events during the study, but is not part of the Maintenance Phase study objectives.

Drug: Cetuximab; Drug: Fluoropyrimidine (5-FU/LV or capecitabine); Drug: Atezolizumab; Drug: Vemurafenib; Drug: Bevacizumab; Drug: 5-FU/LV

Interventions

Cetuximab DRUG

500 mg/m\^2 via IV infusion on Day 1 of every 2-week cycle

Cohort 1 (Maintenance Phase[MP]):5-FU/LV,cetuximab,vemurafenib; Early Progressing BRAFmut Cohort

FOLFOX induction regimen DRUG

Administered per the Investigator's discretion in accordance with locally approved prescribing information.

Cohort 1: Induction Phase (IP); Cohort 2 (IP); Cohort 3 (IP); Cohort 4 (IP)

Fluoropyrimidine (5-FU/LV or capecitabine) DRUG

Per Investigator's discretion: 5-FU 1600-2400 mg/m\^2 administered via 46-hour IV infusion on Day 1 of every 2-week cycle and LV 400 mg/m\^2 administered via a 2-hour infusion on Day 1 every 2 weeks or 1000 mg/m\^2 twice-daily capecitabine (BID) by mouth given days 1-14 every 2 weeks. The chosen fluoropyrimidine should be administered in accordance with local prescribing information.

Cohort 1 Control (MP): 5-FU/LV or capecitabin, bevacizumab; Cohort 2 (MP):5-FU/LV or capecitabine,bevacizumab,atezolizumab; Cohort 2 Control (MP): 5-FU/LV or capecitabin, bevacizumab; Cohort 3 Control (MP): 5-FU/LV or capecitabin, bevacizumab; Cohort 4 Control (MP): 5-FU/LV or capecitabin, bevacizumab; Early Progressing BRAFmut Cohort

Atezolizumab DRUG

800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle, or a fixed dose of 840 mg

Also known as: MPDL3280A, RO5541267

Cohort 2 (MP):5-FU/LV or capecitabine,bevacizumab,atezolizumab; Cohort 4 (MP): Cobimetinib,atezolizumab; Early Progressing BRAFmut Cohort

Vemurafenib DRUG

960 mg vermurafenib BID by mouth

Also known as: RO5185426

Cohort 1 (Maintenance Phase[MP]):5-FU/LV,cetuximab,vemurafenib; Early Progressing BRAFmut Cohort

Bevacizumab DRUG

5 mg/kg bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle per local prescribing information

Also known as: RO4876646

Cohort 1 Control (MP): 5-FU/LV or capecitabin, bevacizumab; Cohort 1: Induction Phase (IP); Cohort 2 (IP); Cohort 2 (MP):5-FU/LV or capecitabine,bevacizumab,atezolizumab; Cohort 2 Control (MP): 5-FU/LV or capecitabin, bevacizumab; Cohort 3 (IP); Cohort 3 Control (MP): 5-FU/LV or capecitabin, bevacizumab; Cohort 4 (IP); Cohort 4 Control (MP): 5-FU/LV or capecitabin, bevacizumab; Early Progressing BRAFmut Cohort

Trastuzumab DRUG

Initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses by IV infusion on Day 1 of every 3-week treatment cycle

Also known as: RO0452317

Cohort 3 (MP): capecitabine,trastuzumab,pertuzumab

Pertuzumab DRUG

Initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses by IV infusion on Day 1 of each 3-week treatment cycle

Also known as: RO4368451

Cohort 3 (MP): capecitabine,trastuzumab,pertuzumab

Cobimetinib DRUG

60 mg orally once daily for 3 weeks followed by a 1-week treatment break

Also known as: RO5514041

Cohort 4 (MP): Cobimetinib,atezolizumab

5-FU/LV DRUG

1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle until disease progression per the Investigator's assessment using modified Response Evaluation Criteria in Solid Tumors or death from any cause, whichever occurs first. The fluoropyrimidine should be administered in accordance with local prescribing information.

Cohort 1 (Maintenance Phase[MP]):5-FU/LV,cetuximab,vemurafenib; Cohort 1: Induction Phase (IP); Cohort 2 (IP); Cohort 3 (IP); Cohort 4 (IP); Early Progressing BRAFmut Cohort

Capecitabine DRUG

1000 mg/m\^2 twice-daily capecitabine (BID) by mouth given days 1-14 every 2 weeks. The fluoropyrimidine should be administered in accordance with local prescribing information.

Cohort 3 (MP): capecitabine,trastuzumab,pertuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG PS of less than or equal to (\<=) 2
• At least 16 weeks of life expectancy at time of entry into the study
• Histologically confirmed colorectal cancer (CRC) with mCRC confirmed radiologically
• Measureable, unresectable disease according to RECIST 1.1
• No prior chemotherapy for CRC in the metastatic setting
• Archival tumor formalin-fixed paraffin-embedded tissue block from the primary tumor obtained at the time of the initial diagnosis is available
• Adequate hematological, liver and renal function
• Agreement to use highly effective measures of contraception

You may not qualify if:

• Less than 6 months from completion of any prior neoadjuvant or adjuvant chemotherapy, radiotherapy
• Prior or current treatment with bevacizumab or any other anti-angiogenic drug (vascular endothelial growth factor or vascular endothelial growth factor receptor therapies or tyrosine kinase inhibitors)
• Current or recent (within 10 days of study enrollment) use of aspirin (more than \[\>\] 325 milligrams per day \[mg/day\]), clopidogrel (\> 75 mg/day), or current or recent (within 10 days prior to the start of study induction treatment) use of therapeutic oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes (prophylactic uses allowed)
• Active infection requiring intravenous antibiotics at the start of study induction treatment
• Previous or concurrent malignancy, except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the participant has been disease-free for 5 years prior to study entry
• Inadequately controlled hypertension; prior history of hypertensive crisis or hypertensive encephalopathy
• Clinically significant (active) cardiovascular disease, for example cerebrovascular accidents \<= 6 months prior to start of study induction treatment, myocardial infarction \<= 6 months prior to study enrollment, unstable angina, New York Heart Association (NYHA) Functional Classification Grade II or greater congestive heart failure, or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment
• Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months of start of study induction treatment
• Active symptomatic or untreated central nervous system (CNS) metastases; CNS disease other than supratentorial or cerebellar metastases (in other words, patients with metastases to midbrain, pons, medulla or spinal cord are excluded); history of or known carcinomatous meningitis
• Known hypersensitivity to any component of any of the study induction or maintenance treatment medications
• Pregnancy or lactation
• Inability to swallow pills
• Refractory nausea and vomiting, malabsorption, external biliary shunt or significant bowel resection that would preclude adequate absorption
• History or presence of clinically significant ventricular or atrial dysrhythmias
• Corrected QT (QTc) interval \>= 450 millisecond assessed within 3 weeks prior to randomization, long QT syndrome or, uncorrectable electrolyte abnormalities (including magnesium) or requirement for medicinal products known to prolong the QT interval

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (154)

Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología

Buenos Aires, C1264AAA, Argentina

Location

Centro Oncologico Riojano Integral (CORI)

La Rioja, F5300COE, Argentina

Location

Clínica Viedma

Viedma Rio Negro, R8500ACE, Argentina

Location

Institut Jules Bordet X

Brussels, 1000, Belgium

Location

Hospital Erasme

Brussels, 1070, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

CHC MontLégia

Liège, 4000, Belgium

Location

AZ Delta (Campus Rumbeke)

Roeselare, 8800, Belgium

Location

University Clinical Center of the Republic of Srpska

Banja Luka, 78000, Bosnia and Herzegovina

Location

Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia

Passo Fundo, Rio Grande do Sul, 99010-260, Brazil

Location

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Hospital de Cancer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Hospital Amaral Carvalho

Jaú, São Paulo, 17210-120, Brazil

Location

Faculdade de Medicina de Sao Jose do Rio Preto - FAMERP*X*

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Instituto de Ensino e Pesquisa Sao Lucas - IEP

São Paulo, São Paulo, 01236-030, Brazil

Location

Herlev Hospital; Afdeling for Kræftbehandling

Herlev, 2730, Denmark

Location

Regionshospitalet Gødstrup; Kræftafdelingen

Herning, 7400, Denmark

Location

Rigshospitalet; Onkologisk Klinik

København Ø, 2100, Denmark

Location

Odense Universitetshospital, Onkologisk Afdeling R

Odense C, 5000, Denmark

Location

Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium

Roskilde, 4000, Denmark

Location

National Cancer Institute

Cairo, 11796, Egypt

Location

Ain Shams University Hospital; Oncology

Cairo, Egypt

Location

Clinique Sainte Catherine

Avignon, 84082, France

Location

HOPITAL JEAN MINJOZ; Oncologie

Besançon, 25030, France

Location

Hopital Augustin Morvan; Federation De Cancerologie

Brest, 29200, France

Location

Chu Estaing; Chir Generale Digestive A Et B

Clermont-Ferrand, 63003, France

Location

Hôpital Franco-Britannique- Fondation Cognacq-Jay; Cancerologie

Levallois-Perret, 92300, France

Location

Hopital Claude Huriez; Medecine Interne Oncologie

Lille, 59037, France

Location

Ch De Montbeliard;Chir Generale Digestive

Montbéliard, 25209, France

Location

Hopital Caremeau; Gastro Enterologie

Nîmes, 30029, France

Location

Hopital Saint Antoine; Oncologie Medicale

Paris, 75571, France

Location

Hopital Haut Leveque

Pessac, 33600, France

Location

Chu La Miletrie; Gastro Enterologie Endoscopies

Poitiers, 86021, France

Location

ICANS

Strasbourg, 67200, France

Location

Hopital Rangueil; Gastro Enterologie Et Nutrition

Toulouse, 31059, France

Location

Institut Gustave Roussy; Departement Oncologie Medicale

Villejuif, 94805, France

Location

Hämatologie Onkologie im Zentrum MVZ GmbH

Augsburg, 86150, Germany

Location

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, 10707, Germany

Location

DRK Kliniken Berlin Köpenick Darmzentrum

Berlin, 12559, Germany

Location

BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

Dresden, 01307, Germany

Location

Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie

Frankfurt, 60488, Germany

Location

PIOH PD Dr. R. Schnell ? Dr. H. Schulz ? Dr. M. Hellmann

Frechen, 50226, Germany

Location

Klinik Fulda, Medizinisches Versorgungszentrum Osthessen GmbH

Fulda, 36043, Germany

Location

Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum, Studienzentrale der II. Med. Klinik

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie

Hanover, 30625, Germany

Location

SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.

Heilbronn, 74078, Germany

Location

Klinik der Ruhr-Uni Bochum; Marien-Hospital Herne

Herne, 44625, Germany

Location

Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel

Lebach, 66822, Germany

Location

Onkologische Gemeinschaftspraxis

Magdeburg, 39104, Germany

Location

Klinikum Magdeburg gGmbH Klinik für Allgemein- und Viszeralchirurgie

Magdeburg, 39130, Germany

Location

Universitätsklinikum Magdeburg Klinik für Gastroenterologie und Hepatologie

Mageburg, 39120, Germany

Location

Kliniken Maria Hilf GmbH, Krankenhaus St. Franziskus

Mönchengladbach, 41063, Germany

Location

Städt. Klinikum München GmbH Klinikum Neuperlach Klinik f.Hämatologie u.Onkologie

München, 81737, Germany

Location

Gemeinschaftspraxis für Hämatologie und Onkologie

Münster, 48153, Germany

Location

Brüderkrankenhaus St. Josef

Paderborn, 33098, Germany

Location

Studienzentrum Onkologie Ravensburg GbR; Onkologie Ravensburg

Ravensburg, 88212, Germany

Location

Prosper-Hospital, Medizinische Klinik I

Recklinghausen, 45659, Germany

Location

Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie

Regensburg, 93049, Germany

Location

Klinikum am Steinenberg / Ermstalklinik

Reutlingen, 72764, Germany

Location

Praxis für Hämatologie & Onkologie

Saarbrücken, 66113, Germany

Location

MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken

Stade, 21680, Germany

Location

Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

Trier, 54290, Germany

Location

Klinikum Wetzlar-Braunfels, Klinik für Hämatologie/Onkologie und Palliativmedizin

Wetzlar, 35578, Germany

Location

Agioi Anargyroi; 3Rd Dept. of Medical Oncology

Athens, 145 64, Greece

Location

Univ General Hosp Heraklion; Medical Oncology

Heraklion, 711 10, Greece

Location

Uni Hospital of Ioannina; Oncology Dept.

Ioannina, 455 00, Greece

Location

University Hospital of Patras Medical Oncology

Pátrai, 265 04, Greece

Location

Thermi Clinic; Oncology Clinic

Thermi Thessalonikis, 570 01, Greece

Location

Bioclinic Thessaloniki

Thessaloniki, 546 22, Greece

Location

Euromedical General Clinic of Thessaloniki; Oncology Department

Thessaloniki, 546 45, Greece

Location

IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

San Giovanni Rotondo, Apulia, 71013, Italy

Location

IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A

Napoli, Campania, 80131, Italy

Location

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

Meldola, Emilia-Romagna, 47014, Italy

Location

A.O. Universitaria Di Parma; Oncologia Medica

Parma, Emilia-Romagna, 43100, Italy

Location

Istituto Regina Elena; Oncologia Medica A

Rome, Lazio, 00168, Italy

Location

Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica

Rome, Lazio, 00168, Italy

Location

Humanitas Gavazzeni;U.O. Oncologia Medica

Bergamo, Lombardy, 24121, Italy

Location

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

Milan, Lombardy, 20133, Italy

Location

Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

Milan, Lombardy, 20141, Italy

Location

Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

Milan, Lombardy, 20162, Italy

Location

Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

Florence, Tuscany, 50139, Italy

Location

IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

Padua, Veneto, 35128, Italy

Location

A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U.

Verona, Veneto, 37134, Italy

Location

Fundacion Rodolfo Padilla Padilla A.C.

León, Guanajuato, 37000, Mexico

Location

Oaxaca Site Management Organization

Oaxaca City, Oaxaca, 68000, Mexico

Location

Cancerologia de Queretaro; Oncologia

Queretaro, Queretaro, Querétaro, 76090, Mexico

Location

Instituto Nacional de Cancerologia; Oncology

Mexico City, 14080, Mexico

Location

Antoni van Leeuwenhoek Ziekenhuis

Amsterdam, 1066 CX, Netherlands

Location

Ijsselland Ziekenhuis; Inwendige Geneeskunde

Capelle aan den IJssel, NL 2900 AR, Netherlands

Location

Deventer Ziekenhuis; Interne Geneeskunde

Deventer, 7416 SE, Netherlands

Location

Albert Schweitzer Ziekenhuis - loc Dordrecht

Dordrecht, 3318 AT, Netherlands

Location

Catharina ZKHS; Inwendige Geneeskunde Afd.

Eindhoven, 5623 EJ, Netherlands

Location

St. Antonius locatie Leidsche Rijn

Utrecht, 3543 AZ, Netherlands

Location

Isala Klinieken

Zwolle, 8011 JW, Netherlands

Location

Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

Krakow, 30-688, Poland

Location

Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Onkologii i Radioterapii,

Warsaw, 02-781, Poland

Location

HUC; Servico de Oncologia Medica

Coimbra, 3000-075, Portugal

Location

Hospital de Santa Maria; Servico de Oncologia Medica

Lisbon, 1649-035, Portugal

Location

Bashkirian Republican Clinical Oncology Dispensary

Ufa, Bashkortostan Republic, 450054, Russia

Location

Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

Moscow, Moscow Oblast, 115478, Russia

Location

Institute for Oncology and Radiology of Serbia; Clinic for Medical Oncology

Belgrade, 11000, Serbia

Location

Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E

Bratislava, 833 10, Slovakia

Location

POKO Poprad; Department of Oncology

Poprad, 058 01, Slovakia

Location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital General Universitario de Elche; Servicio de Oncologia

Elche, Alicante, 03203, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

Badalona, Barcelona, 08916, Spain

Location

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Sant Andreu de la Barca, Barcelona, 08740, Spain

Location

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, Cordoba, 14004, Spain

Location

Hospital de Donostia; Servicio de Oncologia Medica

Donostia / San Sebastian, Guipuzcoa, 20080, Spain

Location

Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

Santiago de Compostela, LA Coruña, 15706, Spain

Location

Hospital Universitario Puerta de Hierro; Servicio de Oncologia

Majadahonda, Madrid, 28222, Spain

Location

Hospital de Navarra; Servicio de Oncologia

Navarra, Navarre, 31008, Spain

Location

Hospital Univ. Central de Asturias; Servicio de Oncologia

Oviedo, Principality of Asturias, 33011, Spain

Location

Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

Santa Cruz de Tenerife, Tenerife, 38010, Spain

Location

Hospital General Univ. de Alicante; Servicio de Oncologia

Alicante, 3010, Spain

Location

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

Jaén, 23007, Spain

Location

Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

Lleida, 25198, Spain

Location

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, 28007, Spain

Location

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, 28041, Spain

Location

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, 28046, Spain

Location

Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

Málaga, 29011, Spain

Location

Complejo Hospitalario de Orense; Servicio de Oncologia

Ourense, 32005, Spain

Location

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

Valencia, 46010, Spain

Location

Hospital General Universitario de Valencia; Servicio de oncologia

Valencia, 46014, Spain

Location

Hospital Universitario la Fe; Servicio de Oncologia

Valencia, 46026, Spain

Location

Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia

Zaragoza, 50009, Spain

Location

Hospital Universitario Miguel Servet; Servicio Oncologia

Zaragoza, 50009, Spain

Location

Skånes University Hospital, Skånes Department of Onclology

Lund, 221 85, Sweden

Location

Karolinska Hospital; Oncology - Radiumhemmet

Stockholm, 171 76, Sweden

Location

Acibadem University School of Medicine, Adana Hospital; General Surgery

Adana, 01130, Turkey (Türkiye)

Location

Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

Edirne, 22770, Turkey (Türkiye)

Location

Istanbul Uni Capa Medical Faculty; Inst. of Oncology

Istanbul, 34093, Turkey (Türkiye)

Location

Marmara Uni Faculty of Medicine; Medical Oncology

Istanbul, 34890, Turkey (Türkiye)

Location

Ege Uni Medical Faculty Hospital; Oncology Dept

Izmir, 35100, Turkey (Türkiye)

Location

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sihhiye/Ankara, 06230, Turkey (Türkiye)

Location

Aberdeen Royal Infirmary; Medical Oncology Dept

Aberdeen, AB25 2ZN, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Broomfield Hospital; Oncology

Chelsmford, CM1 7ET, United Kingdom

Location

Castle Hill Hospital; The Queens Centre for Oncology and Haematology

Cottingham, HU16 5JG, United Kingdom

Location

Guys and St Thomas NHS Foundation Trust, Guys Hospital

London, SE1 9RT, United Kingdom

Location

Royal Marsden Hospital; Dept of Med-Onc

London, SW3 6JJ, United Kingdom

Location

Christie Hospital Nhs Trust; Medical Oncology

Manchester, M2O 4BX, United Kingdom

Location

Mount Vernon Hospital

Middlesex, HA6 2RN, United Kingdom

Location

Queen's Hospital

Romford, RM7 0AG, United Kingdom

Location

Southampton General Hospital; Medical Oncology

Southampton, SO16 6YD, United Kingdom

Location

Royal Marsden Hospital; Dept. of Medicine

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (1)

• Ducreux M, Tabernero J, Grothey A, Arnold D, O'Dwyer PJ, Gilberg F, Abbas A, Thakur MD, Prizant H, Irahara N, Tahiri A, Schmoll HJ, Van Cutsem E, de Gramont A. Clinical and exploratory biomarker findings from the MODUL trial (Cohorts 1, 3 and 4) of biomarker-driven maintenance therapy for metastatic colorectal cancer. Eur J Cancer. 2023 May;184:137-150. doi: 10.1016/j.ejca.2023.01.023. Epub 2023 Feb 4.

  PMID: 36921494 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab; Capecitabine; atezolizumab; Vemurafenib; Bevacizumab; Trastuzumab; pertuzumab; cobimetinib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 14, 2014
• Study Start: April 17, 2015
• Primary Completion: May 31, 2019
• Study Completion: March 24, 2021
• Last Updated: May 6, 2024
• Results First Posted: July 24, 2020

Record last verified: 2023-10

Locations

TU (6); RU (2); BR (7); ES (26); EG (2); GB (11); DK (5); NL (7); SL (1); BO (1); FR (14); GR (7); DE (27); PT (2); KR (4); ME (4); AR (3); PL (2); SE (2); IT (13); BE (5)