Trial Title:
A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon Cancer
NCT ID:
NCT06567782
Condition:
Neoplasms, Colon
Conditions: Official terms:
Colonic Neoplasms
Dostarlimab
Conditions: Keywords:
Colon cancer
MMRp
MSS
Dostarlimab
CAPEOX
Neoadjuvant
GSK4057190A
TSR-042
Chemotherapy
Immunotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Dostarlimab
Description:
Dostarlimab will be administered.
Arm group label:
Dostarlimab plus CAPEOX
Other name:
GSK4057190A
Other name:
TSR-042
Intervention type:
Drug
Intervention name:
CAPEOX
Description:
CAPEOX chemotherapy consisting of capecitabine and oxaliplatin will be administered.
Arm group label:
CAPEOX
Arm group label:
Dostarlimab plus CAPEOX
Summary:
The main goal of this study is to test a new treatment approach for colon cancer. The
treatment involves dostarlimab along with a specific type of chemotherapy called CAPEOX
(short for "capecitabine + oxaliplatin") to check if using these two together works
better than using just CAPEOX by itself. This treatment is given before any surgery takes
place; a method referred to as "neoadjuvant therapy." . The aim is to see if this new
approach can show early signs of effectiveness in treating participants with a specific
type of colon cancer known as mismatch repair proficient/ microsatellite stable
(MMRp/MSS), where the cells have normal repair systems and stable DNA sequences. This
study will also look at specific signs in the blood and tumor to see if they can help
predict how well the treatment is working. This could help better understand how
dostarlimab contributes to the response of the disease to treatment.
Criteria for eligibility:
Criteria:
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-
1. MMR status: MMR status must be assessed by Immunohistochemistry (IHC) for MMR
protein expression (MLH1, MSH2, MSH6, PMS2) where all proteins are present
indicates MMRp; MMR status may be determined local laboratory; or
2. MSS or MSI-L phenotype as determined by polymerase 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 screening
period 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 Criteria:
- Has distant metastatic disease
- Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or
targeted 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 has
any 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., myasthenic
syndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse
myelitis), exfoliative dermatitis of any grade [Stevens-Johnson Syndrome (SJS),
Toxic Epidermal Necrolysis (TEN), or Drug rash with eosinophilia and systemic
symptoms (DRESS) syndrome], or myocarditis of any grade. Non-clinically significant
laboratory 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 laboratory
abnormality that might confound the study results, interfere with their
participation for the full duration of the study intervention, or indicate it is not
in the best interest of the participant to participate, in the opinion of the
investigator
- Is considered, in investigator's opinion, a poor medical risk due to a serious,
uncontrolled medical disorder, non-malignant systemic disease, or active infection
requiring systemic therapy
- Has received treatment with an investigational agent within [4 weeks] of the first
dose 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 its
excipients, or any components of CAPEOX
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
GSK Investigational Site
Address:
City:
Aalst
Zip:
9300
Country:
Belgium
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Koenraad A.M. (Koen) Hendrickx
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Bonheiden
Zip:
2820
Country:
Belgium
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Pieter-Jan Cuyle
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Bruxelles
Zip:
1070
Country:
Belgium
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Francesco Sclafani
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Bruxelles
Zip:
1200
Country:
Belgium
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Marc Van den Eynde
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Els Monsaert
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Sabine Tejpar
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
LiEge
Zip:
4000
Country:
Belgium
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Joëlle Collignon
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Liege
Zip:
4000
Country:
Belgium
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Gauthier Demolin
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Roeselare
Zip:
8800
Country:
Belgium
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Sofie De Meulder
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Elena Élez Fernández
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Madrid
Zip:
28222
Country:
Spain
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Ana Ruiz Casado
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Glasgow
Zip:
G12 0YN
Country:
United Kingdom
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Janet Graham
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Leeds West Yorkshire
Zip:
LS9 7TF
Country:
United Kingdom
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Jenny Seligmann
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
London
Zip:
NW1 2PG
Country:
United Kingdom
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Kai-Keen Shiu
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Naureen Starling
Email:
Principal Investigator
Start date:
December 5, 2024
Completion date:
September 7, 2028
Lead sponsor:
Agency:
GlaxoSmithKline
Agency class:
Industry
Source:
GlaxoSmithKline
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06567782
