Phase
Condition
Colorectal Cancer
Colon Cancer
Treatment
Dostarlimab
CAPEOX
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has untreated pathologically confirmed colon adenocarcinoma
Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III
Has a tumor demonstrating the presence of either-
MMR status: MMR status must be assessed by Immunohistochemistry (IHC) for MMRprotein expression (MLH1, MSH2, MSH6, PMS2) where all proteins are presentindicates MMRp; MMR status may be determined local laboratory; or
MSS or Microsatellite Instability-L (MSI-L) phenotype as determined bypolymerase chain reaction (PCR) or by tissue next generation sequencing (NGS),determined by local laboratory
Provides fresh tumor tissue obtained during either the pre-screening or screeningperiod via colonoscopy performed per procedure manual. Tissue biopsy is required
Is willing to use adequate contraception male and/or female participants
Has an Eastern Cooperative Oncology Group - Performance status (ECOG-PS) of 0 or 1
Has adequate organ function
Exclusion
Exclusion Criteria:
Has distant metastatic disease
Has received prior medical therapy (chemotherapy, immunotherapy, biologic, ortargeted therapy), radiation therapy or surgery for management of colon cancer
Has, in the investigator's opinion, a tumor that is not amenable to surgery or hasany other contraindication to surgery
Has experienced any of the following with prior immunotherapy: any imAE ≥ Grade 3,immune-mediated severe neurologic events of any-grade (e.g., myasthenicsyndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transversemyelitis), exfoliative dermatitis of any grade [Stevens-Johnson Syndrome (SJS),Toxic Epidermal Necrolysis (TEN), or Drug rash with eosinophilia and systemicsymptoms (DRESS) syndrome], or myocarditis of any grade. Non-clinically significantlaboratory abnormalities are not exclusionary
Has any history of interstitial lung disease or immune-related pneumonitis
Has a history or current evidence of any medical condition, therapy, or laboratoryabnormality that might confound the study results, interfere with theirparticipation for the full duration of the study intervention, or indicate it is notin the best interest of the participant to participate, in the opinion of theinvestigator
Is considered, in investigator's opinion, a poor medical risk due to a serious,uncontrolled medical disorder, non-malignant systemic disease, or active infectionrequiring systemic therapy
Has received treatment with an investigational agent within [4 weeks] of the firstdose of study intervention
Is pregnant or breastfeeding
Has a history of severe allergic and/or anaphylactic reactions to chimeric, human,or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or itsexcipients, or any components of CAPEOX
Study Design
Connect with a study center
GSK Investigational Site
Aalst, 9300
BelgiumSite Not Available
GSK Investigational Site
Bonheiden, 2820
BelgiumSite Not Available
GSK Investigational Site
Bruxelles, 1200
BelgiumSite Not Available
GSK Investigational Site
Gent, 9000
BelgiumSite Not Available
GSK Investigational Site
Leuven, 3000
BelgiumActive - Recruiting
GSK Investigational Site
LiEge, 4000
BelgiumSite Not Available
GSK Investigational Site
Roeselare, 8800
BelgiumSite Not Available
GSK Investigational Site
Barcelona, 8035
SpainSite Not Available
GSK Investigational Site
Madrid, 28222
SpainSite Not Available
GSK Investigational Site
Glasgow, G12 0YN
United KingdomSite Not Available
GSK Investigational Site
Leeds West Yorkshire, LS9 7TF
United KingdomSite Not Available
GSK Investigational Site
London, NW1 2PG
United KingdomSite Not Available
GSK Investigational Site
Sutton, SM2 5PT
United KingdomSite Not Available
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