← Back to searchRecruitingRecruiting
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
NCT04929223 · Hoffmann-La Roche
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
About this study
This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.
Eligibility criteria
Inclusion Criteria
* Signed cohort-specific Informed Consent Form
* Age \>= 18 years at time of signing Informed Consent Form
* Biomarker eligibility as determined by:
* A validated test approved by local health authorities for detection of the specified biomarkers/mutations.
* A validated test performed at a College of American Pathologists/clinical laboratory improvement amendments (CAP/CLIA) -certified or equivalently accredited diagnostic laboratory using a validated test for detection of the specified biomarkers.
* Prior test results completed before signing cohort-specific Informed Consent Form or local test results generated prior to or during screening, and availability of a full report of the testing results OR
* Blood-based FoundationOne Liquid CDx biomarker eligibility test result generated prior to or during screening or, in case of re-enrollment after treatment discontinuation, prior to starting a new anti-cancer therapy.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of \<= 1
* Life expectancy \>= 3 months, as determined by the investigator
* Histologically confirmed adenocarcinoma originating from the colon or rectum
* Metastatic disease
* Prior therapies for metastatic disease
* Ability to comply with the study protocol, in the investigators judgment
* Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
* Baseline tumor tissue samples will be collected from all participants for exploratory biomarker research
* Adequate hematologic and organ function within 14 days prior to initiation of study treatment
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
* For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
Exclusion Criteria
* Current participation or enrollment in another interventional clinical trial. Participants who are participating in the follow-up period of an interventional clinical trial are eligible for the study.
* Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study treatment
* Treatment with investigational therapy within 28 days prior to initiation of study treatment
* Pregnant or breastfeeding, or intending to become pregnant during the study
* History of or concurrent 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 or confounds the ability to interpret data from the study
* Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
* Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
* Uncontrolled tumor-related pain
* Uncontrolled or symptomatic hypercalcemia
* Clinically significant and active liver disease
* Negative HIV test at screening, with the following exception: Participants with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count greater than or equal to 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.
* Symptomatic, untreated, or actively progressing CNS metastases
* History of leptomeningeal disease or carcinomatous meningitis
* History of malignancy other than CRC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
* Any other disease, unresolved toxicity from prior therapy, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications
* Requirement for treatment with any medicinal product that contraindicates the use of any of the study treatments, may interfere with the planned treatment, affects participant compliance, or puts the patient at higher risk for treatment-related complications
Study design
Enrollment target: 542 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-10-22
Estimated completion: 2030-08-31
Last updated: 2026-03-31
Interventions
Drug: InavolisibDrug: BevacizumabDrug: CetuximabDrug: AtezolizumabDrug: TiragolumabDrug: SY-5609Drug: DivarasibDrug: FOLFOXDrug: FOLFIRIDiagnostic Test: FoundationOne®Liquid CDx
Primary outcomes
- • Objective Response Rate (Approximately 84 months)
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: WO42758 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S. and Canada)
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (74)
UAB Comprehensive Cancer CenterWithdrawn
Birmingham, Alabama, United States
Mayo Clinic ArizonaCompleted
Phoenix, Arizona, United States
City of Hope Comprehensive Cancer CenterActive Not Recruiting
Duarte, California, United States
cCareWithdrawn
Encinitas, California, United States
USC Norris Cancer CenterCompleted
Los Angeles, California, United States
Cedars-Sinai Medical CenterActive Not Recruiting
Los Angeles, California, United States
UCLARecruiting
Los Angeles, California, United States
Hoag Memorial Hospital PresbyterianWithdrawn
Newport Beach, California, United States
Stanford Cancer CenterCompleted
Stanford, California, United States
University of Colorado Cancer CenterActive Not Recruiting
Aurora, Colorado, United States
Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Eastern Ct Hema/Onco AssocRecruiting
Norwich, Connecticut, United States
Mayo Clinic in FloridaWithdrawn
Jacksonville, Florida, United States
Moffitt Cancer CenterActive Not Recruiting
Tampa, Florida, United States
Mary Bird Perkins Cancer CtrRecruiting
Baton Rouge, Louisiana, United States
Massachusetts General HospitalCompleted
Boston, Massachusetts, United States
Karmanos Cancer InstituteWithdrawn
Detroit, Michigan, United States
Mayo Clinic RochesterRecruiting
Rochester, Minnesota, United States
New York Cancer & Blood Specialists - New Hyde ParkRecruiting
New Hyde Park, New York, United States
New York Cancer and Blood Specialists-Central Park Hematology & OncologyRecruiting
New York, New York, United States
New York Cancer & Blood SpecialistsRecruiting
Port Jefferson Station, New York, United States
New York Cancer & Blood Specialists - BronxRecruiting
The Bronx, New York, United States
Duke University Medical CenterCompleted
Durham, North Carolina, United States
Hematology Oncology SalemActive Not Recruiting
Salem, Oregon, United States
UPMC - Hillman Cancer CenterActive Not Recruiting
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute / Tennessee OncologyCompleted
Nashville, Tennessee, United States
Vanderbilt University Medical CenterCompleted
Nashville, Tennessee, United States
Lumi ResearchWithdrawn
Kingwood, Texas, United States
Swedish Cancer Inst.Completed
Seattle, Washington, United States
Medical Oncology AssociatesWithdrawn
Spokane, Washington, United States
Peter Maccallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
Princess Margaret Cancer CenterActive Not Recruiting
Toronto, Ontario, Canada
Jewish General HospitalWithdrawn
Montreal, Quebec, Canada
McGill University Health CenterWithdrawn
Montreal, Quebec, Canada
Rigshospitalet, Onkologisk KlinikRecruiting
København Ø, Denmark
Charité Universitätsmedizin BerlinRecruiting
Berlin, Germany
Katholisches Klinikum Bochum gGmbH - St. Josef-HospitalRecruiting
Bochum, Germany
Universitätsklinik Carl Gustav Carus der Technischen Universität DresdenRecruiting
Dresden, Germany
Universitätsklinikum DüsseldorfRecruiting
Düsseldorf, Germany
Asklepios Klinik AltonaRecruiting
Hamburg, Germany
SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin IIIRecruiting
Heilbronn, Germany
Klinikum der Universität München, Campus GroßhadernWithdrawn
München, Germany
Universitätsklinikum UlmRecruiting
Ulm, Germany
Università degli Studi della Campania Luigi VanvitelliRecruiting
Naples, Campania, Italy
Policlinico Universitario Agostino Gemelli IRCCSRecruiting
Rome, Lazio, Italy
Irccs Istituto Nazionale Dei Tumori (Int)Recruiting
Milan, Lombardy, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)Recruiting
Milan, Lombardy, Italy
IRCCS Istituto Oncologico Veneto (IOV)Recruiting
Padova, Veneto, Italy
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki OnkologiiSuspended
Krakow, Poland
Uniwersytecki Szpital Kliniczny w PoznaniuRecruiting
Poznan, Poland
Narodowy Instytut Onkologii im. M. Sklodowskiej-CurieSuspended
Warsaw, Poland
National Cancer CenterRecruiting
Goyang-si, South Korea
Chonnam National University Hwasun HospitalRecruiting
Jeollanam-do, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam-si, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Hospital Universitario Puerta de Hierro - MajadahondaRecruiting
Majadahonda, Madrid, Spain
Vall d'Hebron Institute of Oncology (VHIO), BarcelonaRecruiting
Barcelona, Spain
START Madrid-FJD, Hospital Fundacion Jimenez DiazRecruiting
Madrid, Spain
START Madrid. Centro Integral Oncologico Clara CampalWithdrawn
Madrid, Spain
Hospital Clínico Universitario de ValenciaRecruiting
Valencia, Spain
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
National Taiwan University HospitalRecruiting
Zhongzheng Dist., Taiwan
Addenbrookes HospitalRecruiting
Cambridge, United Kingdom
Velindre Cancer CentreRecruiting
Cardiff, United Kingdom
Royal Free HospitalWithdrawn
London, United Kingdom
Royal Marsden Hospital;Dept of Med-OncRecruiting
London, United Kingdom
Sarah Cannon Research InstituteRecruiting
London, United Kingdom
Imperial College Healthcare NHS TrustRecruiting
London, United Kingdom
The Christie NHS Foundation TrustRecruiting
Manchester, United Kingdom
Royal Marsden HospitalRecruiting
Sutton, United Kingdom