Phase
Condition
Neoplasms
Solid Tumors
Treatment
FOLFIRI
FOLFOX
Cetuximab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥18 years old
Histologically or cytologically confirmed advanced or metastatic malignancies asdefined in the protocol.
Part 1: Participants must have experienced disease progression after treatment with,be intolerant to, or be ineligible for, or refused available therapies, includinganti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinicalbenefit. Part 2: depending on cohort, participants may have received or not priortreatment for the malignancy under study.
ECOG performance status score of 0 or 1.
Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional).Biopsies are mandatory depending on the cohorts.
Presence of measurable disease according to RECIST v1.1.
Exclusion
Exclusion Criteria:
Any known additional malignancy that is progressing or requires active treatment, orhistory of other malignancy within 2 years.
Not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy.
Has active autoimmune disease requiring systemic immunosuppression withcorticosteroids.
Brain or CNS metastases untreated or that have progressed.
History of organ transplant, including allogeneic stem cell transplantation.
History of clinically significant or uncontrolled cardiac disease.
Active HBV, active HCV, or HIV positive.
Is on chronic systemic steroids (> 10 mg/day of prednisone or equivalent).
Chronic or current active infectious disease requiring systemic antibiotics,antifungal, or antiviral treatment
Participants that have been initiated on or had modifications in anticoagulationtherapies within the last 3 months prior to first dose of treatment.
Significant concurrent, uncontrolled medical condition, eg:
Cardiovascular: Participants with known vasculitis, aneurisms, and othervascular malformations of clinical significance or history of myocarditis.
Gastrointestinal: Any bowel obstruction within 60 days prior to C1D1.
Participants with adequate laboratory values within the protocol defined ranges.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Study Design
Connect with a study center
Rigshospitalet Uni of Hospital of Copenhagen
Copenhagen, 02100
DenmarkSite Not Available
Rigshospitalet Uni of Hospital of Copenhagen
Copenhagen 2618425, 02100
DenmarkActive - Recruiting
Herlev Og Gentofte Hospital
Herlev, 02730
DenmarkSite Not Available
Herlev Og Gentofte Hospital
Herlev 2620431, 02730
DenmarkActive - Recruiting
Odense University Hospital
Odense C, 05000
DenmarkSite Not Available
Odense University Hospital
Odense C 11746507, 05000
DenmarkActive - Recruiting
Vejle Hospital
Vejle, 07100
DenmarkSite Not Available
Vejle Hospital
Vejle 2610613, 07100
DenmarkActive - Recruiting
Centre Leon Berard
Lyon, 69373
FranceSite Not Available
Centre Leon Berard
Lyon 2996944, 69373
FranceActive - Recruiting
Institut Paoli Calmettes
Marseille, 13009
FranceSite Not Available
Institut Gustave Roussy
Villejuif 2968705, 94805
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif Cedex, 94805
FranceSite Not Available
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan 6951411, 20133
ItalyActive - Recruiting
Fondazione Irccs Istituto Nazionale Dei Tumori
Milano, 20133
ItalySite Not Available
Fondazione Irccs Istituto Nazionale Del Tumori Di Milano
Milano, 20133
ItalyActive - Recruiting
Irccs Istituto Clinico Humanitas
Rozzano, 20089
ItalySite Not Available
Irccs Istituto Clinico Humanitas
Rozzano 3168837, 20089
ItalyActive - Recruiting
Centro Ricerche Cliniche Di Verona
Verona, 37134
ItalySite Not Available
Centro Ricerche Cliniche Di Verona (Crc)
Verona, 37134
ItalyActive - Recruiting
Centro Ricerche Cliniche Di Verona
Verona 3164527, 37134
ItalyActive - Recruiting
Kansai Medical University Hospital
Hirakata, 573-1191
JapanSite Not Available
Kansai Medical University Hospital
Hirakata 1862540, 573-1191
JapanActive - Recruiting
The Cancer Institute Hospital of Jfcr
Koto-ku, 135-8550
JapanSite Not Available
The Cancer Institute Hospital of Jfcr
Kōtoku 2128852, 135-8550
JapanSite Not Available
National Cancer Center Hospital
Tokyo, 104-0045
JapanSite Not Available
National Cancer Center Hospital
Tokyo 1850147, 104-0045
JapanActive - Recruiting
The Cancer Institute Hospital of Jfcr
Tokyo 1850147, 135-8550
JapanActive - Recruiting
Hospital General Universitario Vall D Hebron
Barcelona, 08035
SpainSite Not Available
Start Barcelona
Barcelona, 08023
SpainActive - Recruiting
Hospital General Universitario Vall D Hebron
Barcelona 3128760, 08035
SpainActive - Recruiting
Start Barcelona
Barcelona 3128760, 08023
SpainActive - Recruiting
Centro Integral Oncologico Clara Campal
Madrid, 28050
SpainActive - Recruiting
Fundacion Jimenez Diaz University Hospital
Madrid, 28040
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Centro Integral Oncologico Clara Campal
Madrid 3117735, 28050
SpainActive - Recruiting
Fundacion Jimenez Diaz University Hospital
Madrid 3117735, 28040
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid 3117735, 28041
SpainActive - Recruiting
Istituto Oncologico Della Svizzera Italiana
Bellinzona, 06500
SwitzerlandSite Not Available
Istituto Oncologico Della Svizzera Italiana
Bellinzona 2661567, 06500
SwitzerlandActive - Recruiting
Centre Hospitalier Universitaire Vaudois (Chuv)
Lausanne, 01011
SwitzerlandSite Not Available
Centre Hospitalier Universitaire Vaudois (Chuv)
Lausanne 2659994, 01011
SwitzerlandActive - Recruiting
Kantonsspital St. Gallen
Sankt Gallen 2658822, 09007
SwitzerlandActive - Recruiting
Kantonsspital St. Gallen
St. Gallen, 09007
SwitzerlandSite Not Available
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, CB2 0QQ
United KingdomSite Not Available
Cambridge University Hospitals Nhs Foundation Trust
Cambridge 2653941, CB2 0QQ
United KingdomActive - Recruiting
Guys and St Thomas Nhs Foundation Trust
London, SE1 9RT
United KingdomSite Not Available
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, W12 0HS
United KingdomActive - Recruiting
Guys and St Thomas Nhs Foundation Trust
London 2643743, SE1 9RT
United KingdomActive - Recruiting
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London 2643743, W12 0HS
United KingdomActive - Recruiting
The Christie Nhs Foundation Trust Uk
Manchester, M20 4BV
United KingdomSite Not Available
The Christie Nhs Foundation Trust Uk
Manchester 2643123, M20 4BV
United KingdomActive - Recruiting
Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust
Newcastle Upon Tyne, NE7 7DN
United KingdomSite Not Available
Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust
Newcastle upon Tyne 2641673, NE7 7DN
United KingdomActive - Recruiting
The Angeles Clinic and Research Institute
Los Angeles, California 90025
United StatesActive - Recruiting
Valkyrie Clinical Trials
Los Angeles, California 90067
United StatesSite Not Available
The Angeles Clinic and Research Institute
Los Angeles 5368361, California 5332921 90025
United StatesActive - Recruiting
Valkyrie Clinical Trials
Los Angeles 5368361, California 5332921 90067
United StatesActive - Recruiting
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
Cancer and Hematology Centers of Western Michigan-Start Midwest
Grand Rapids, Michigan 49546
United StatesSite Not Available
Cancer and Hematology Centers of Western Michigan-Start Midwest
Grand Rapids 4994358, Michigan 5001836 49546
United StatesActive - Recruiting
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
United StatesActive - Recruiting
Nyu Langone Health - Long Island Hospital
Mineola, New York 11501
United StatesSite Not Available
Laura and Isaac Perlmutter Cancer Center
New York, New York 10016
United StatesSite Not Available
Nyu Langone Health - Long Island Hospital
Mineola 5127134, New York 5128638 11501
United StatesActive - Recruiting
Laura and Isaac Perlmutter Cancer Center
New York 5128581, New York 5128638 10016
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesActive - Recruiting
Lifespan Cancer Research Institute
Providence, Rhode Island 02903
United StatesSite Not Available
Lifespan Cancer Research Institute
Providence 5224151, Rhode Island 5224323 02903
United StatesActive - Recruiting
University of Texas Md Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
South Texas Accelerated Research Therapeutics
San Antonio, Texas 78229
United StatesSite Not Available
University of Texas Md Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
South Texas Accelerated Research Therapeutics
San Antonio 4726206, Texas 4736286 78229
United StatesActive - Recruiting

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