Actively Recruiting
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
Led by GlaxoSmithKline · Updated on 2026-04-02
120
Participants Needed
33
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has untreated pathologically confirmed colon adenocarcinoma
- Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III
- Has tumor with MMR proficient status by immunohistochemistry or MSS/MSI-L phenotype by PCR or tissue sequencing
- Provides fresh tumor tissue biopsy obtained during pre-screening or screening via colonoscopy
- Is willing to use adequate contraception if male or female
- Has an Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Has adequate organ function
You will not qualify if you...
- Has distant metastatic disease
- Has received prior medical therapy, radiation, or surgery for colon cancer
- Has tumor not suitable for surgery or other surgery contraindications
- Has had severe immune-mediated adverse events or specific neurologic or skin reactions from prior immunotherapy
- Has history of interstitial lung disease or immune-related pneumonitis
- Has medical conditions, therapies, or lab abnormalities that could interfere with study participation or results
- Is considered a poor medical risk due to serious uncontrolled disorders, systemic disease, or active infection
- Has received investigational treatment within 4 weeks before first study dose
- Is pregnant or breastfeeding
- Has severe allergic reactions to antibodies, fusion proteins, dostarlimab, CAPEOX components, or excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
GSK Investigational Site
Aalst, Belgium, 9300
Actively Recruiting
2
GSK Investigational Site
Bonheiden, Belgium, 2820
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3
GSK Investigational Site
Brussels, Belgium, 1070
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4
GSK Investigational Site
Brussels, Belgium, 1200
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5
GSK Investigational Site
Ghent, Belgium, 9000
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6
GSK Investigational Site
Leuven, Belgium, 3000
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7
GSK Investigational Site
Liège, Belgium, 4000
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8
GSK Investigational Site
Liège, Belgium, 4000
Actively Recruiting
9
GSK Investigational Site
Ostend, Belgium, 8400
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10
GSK Investigational Site
Roeselare, Belgium, 8800
Actively Recruiting
11
GSK Investigational Site
Turnhout, Belgium, 2300
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12
GSK Investigational Site
Milan, Italy, 20162
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13
GSK Investigational Site
Roma, Italy, 00168
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14
GSK Investigational Site
Udine, Italy, 33100
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15
GSK Investigational Site
Osaka, Japan, 565-0871
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16
GSK Investigational Site
Osaka, Japan, 5731191
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17
GSK Investigational Site
Tokyo, Japan, 104-0045
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18
GSK Investigational Site
Tokyo, Japan, 135-8550
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19
GSK Investigational Site
Barcelona, Spain, 8025
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20
GSK Investigational Site
Barcelona, Spain, 8035
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21
GSK Investigational Site
Barcelona, Spain, 8036
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22
GSK Investigational Site
Madrid, Spain, 28007
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23
GSK Investigational Site
Madrid, Spain, 28034
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24
GSK Investigational Site
Madrid, Spain, 28041
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25
GSK Investigational Site
Madrid, Spain, 28222
Actively Recruiting
26
GSK Investigational Site
Oviedo, Spain, 33011
Actively Recruiting
27
GSK Investigational Site
Valencia, Spain, 46010
Actively Recruiting
28
GSK Investigational Site
Bern, Switzerland, 3010
Actively Recruiting
29
GSK Investigational Site
Geneva, Switzerland, 1205
Actively Recruiting
30
GSK Investigational Site
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
31
GSK Investigational Site
Leeds West Yorkshire, United Kingdom, LS9 7TF
Actively Recruiting
32
GSK Investigational Site
London, United Kingdom, NW1 2PG
Actively Recruiting
33
GSK Investigational Site
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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