Actively Recruiting
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Led by Hoffmann-La Roche · Updated on 2026-04-27
542
Participants Needed
76
Research Sites
462 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed cohort-specific Informed Consent Form
- Age 18 years or older at time of signing Informed Consent Form
- Biomarker eligibility determined by validated local or blood-based tests
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of 3 months or more
- Histologically confirmed adenocarcinoma of the colon or rectum
- Metastatic disease present
- Prior therapies for metastatic colorectal cancer
- Ability to comply with the study protocol
- Measurable disease with at least one target lesion per RECIST v1.1
- Baseline tumor tissue samples available for biomarker research
- Adequate blood and organ function within 14 days before starting study treatment
- Women of childbearing potential agree to abstinence or use contraception
- Men agree to abstinence or contraception and refrain from sperm donation
You will not qualify if you...
- Currently participating in another interventional clinical trial (follow-up period allowed)
- Systemic anti-cancer treatment within 2 weeks or 5 half-lives before study treatment
- Investigational therapy within 28 days before study treatment
- Pregnant, breastfeeding, or planning pregnancy during the study
- Serious medical condition or lab abnormality that prevents safe participation or data interpretation
- Severe infection within 4 weeks before study treatment or active infection affecting safety
- Incomplete recovery from surgery before study treatment
- Uncontrolled pleural, pericardial effusion, or ascites needing frequent drainage
- Uncontrolled tumor-related pain
- Uncontrolled or symptomatic high calcium levels
- Clinically significant active liver disease
- Untreated or progressing brain metastases
- History of leptomeningeal disease or carcinomatous meningitis
- Other malignancies within 2 years except low-risk cancers
- Any condition or toxicity contraindicating investigational drug use or increasing risk of complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 76 locations
1
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35233
Withdrawn
2
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85259
Completed
3
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Active, Not Recruiting
4
cCare
Encinitas, California, United States, 92024
Withdrawn
5
USC Norris Cancer Center
Los Angeles, California, United States, 90033
Completed
6
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Active, Not Recruiting
7
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
8
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Withdrawn
9
Stanford Cancer Center
Stanford, California, United States, 94305-5820
Completed
10
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Active, Not Recruiting
11
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
12
Eastern Ct Hema/Onco Assoc
Norwich, Connecticut, United States, 06360
Actively Recruiting
13
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Withdrawn
14
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Active, Not Recruiting
15
Mary Bird Perkins Cancer Ctr
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
16
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2621
Completed
17
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Withdrawn
18
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55902
Actively Recruiting
19
New York Cancer & Blood Specialists - New Hyde Park
New Hyde Park, New York, United States, 11042-1116
Actively Recruiting
20
New York Cancer and Blood Specialists-Central Park Hematology & Oncology
New York, New York, United States, 10028
Actively Recruiting
21
New York Cancer & Blood Specialists
Port Jefferson Station, New York, United States, 11776
Actively Recruiting
22
New York Cancer & Blood Specialists - Bronx
The Bronx, New York, United States, 10469-5930
Actively Recruiting
23
Duke University Medical Center
Durham, North Carolina, United States, 27710
Completed
24
Hematology Oncology Salem
Salem, Oregon, United States, 97301
Active, Not Recruiting
25
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Active, Not Recruiting
26
Sarah Cannon Research Institute / Tennessee Oncology
Nashville, Tennessee, United States, 37203
Completed
27
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Completed
28
Lumi Research
Kingwood, Texas, United States, 77339
Withdrawn
29
Swedish Cancer Inst.
Seattle, Washington, United States, 98104
Completed
30
Medical Oncology Associates
Spokane, Washington, United States, 99208
Withdrawn
31
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
32
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 1X6
Active, Not Recruiting
33
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Withdrawn
34
McGill University Health Center
Montreal, Quebec, Canada, H4A 3J1
Withdrawn
35
Rigshospitalet, Onkologisk Klinik
København Ø, Denmark, 2100
Actively Recruiting
36
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
37
Katholisches Klinikum Bochum gGmbH - St. Josef-Hospital
Bochum, Germany, 44791
Actively Recruiting
38
Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
Dresden, Germany, 01307
Actively Recruiting
39
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
40
Asklepios Klinik Altona
Hamburg, Germany, 22763
Actively Recruiting
41
SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III
Heilbronn, Germany, 74078
Actively Recruiting
42
Klinikum der Universität München, Campus Großhadern
München, Germany, 81377
Withdrawn
43
Universitätsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
44
Università degli Studi della Campania Luigi Vanvitelli
Naples, Campania, Italy, 80131
Actively Recruiting
45
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
Meldola, Emilia-Romagna, Italy, 47014
Actively Recruiting
46
Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy, 00168
Actively Recruiting
47
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, Italy, 20133
Actively Recruiting
48
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
Milan, Lombardy, Italy, 20162
Actively Recruiting
49
IRCCS Istituto Oncologico Veneto (IOV)
Padova, Veneto, Italy, 35128
Actively Recruiting
50
Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz
Gdansk, Poland, 80-952
Actively Recruiting
51
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
Krakow, Poland, 30-688
Suspended
52
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland, 60-569
Actively Recruiting
53
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
Warsaw, Poland, 02-781
Suspended
54
National Cancer Center
Goyang-si, South Korea, 10408
Actively Recruiting
55
Chonnam National University Hwasun Hospital
Jeollanam-do, South Korea, 58128
Actively Recruiting
56
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13605
Actively Recruiting
57
Samsung Medical Center
Seoul, South Korea, (0)6351
Actively Recruiting
58
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
59
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
60
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
61
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
62
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, Spain, 08035
Actively Recruiting
63
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
64
START Madrid. Centro Integral Oncologico Clara Campal
Madrid, Spain, 28050
Withdrawn
65
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
66
National Cheng Kung University Hospital
Tainan, Taiwan, 00704
Actively Recruiting
67
Taipei Veterans General Hospital
Taipei, Taiwan, 112201
Actively Recruiting
68
National Taiwan University Hospital
Zhongzheng Dist., Taiwan, 10048
Actively Recruiting
69
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
70
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
71
Royal Free Hospital
London, United Kingdom, NW3 2QG
Withdrawn
72
Royal Marsden Hospital;Dept of Med-Onc
London, United Kingdom, SW3 6JJ
Actively Recruiting
73
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
Actively Recruiting
74
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
Actively Recruiting
75
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
76
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
R
Reference Study ID Number: WO42758 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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