Actively Recruiting
A Phase 2, Open Label, Randomized Study of Neoadjuvant Dostarlimab Plus CAPEOX Versus CAPEOX in Participants With Previously Untreated T4N0 or Stage III MMRp/MSS Colon Cancer
Led by GlaxoSmithKline · Updated on 2026-05-22
120
Participants Needed
33
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for colon cancer, focusing on a specific type called mismatch repair proficient/microsatellite stable (MMRp/MSS) colon cancer. This Phase 2 study compares a combination of dostarlimab with CAPEOX chemotherapy to CAPEOX chemotherapy alone. The study aims to find early signs of how well this combination works before surgery and to understand how blood and tumor markers might predict treatment response. Participants will be randomly assigned to receive either dostarlimab plus CAPEOX chemotherapy or CAPEOX chemotherapy alone. Both treatments are given before surgery, a process known as neoadjuvant therapy. The study includes two groups: one receiving the combination treatment and the other receiving only chemotherapy. Treatment duration and follow-up are planned to assess response and safety. During the study, participants will undergo various assessments including tumor tissue collection via colonoscopy, evaluations of tumor response, and monitoring for adverse events. Researchers will measure major pathological response rates and track any side effects up to approximately 105 weeks. The study also looks at the percentage of participants who can undergo tumor removal surgery, and detailed pathological response rates. Safety and effectiveness are monitored throughout the treatment and follow-up periods.
CONDITIONS
Brief 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...
- Untreated pathologically confirmed colon adenocarcinoma
- Resectable colon adenocarcinoma defined as clinically T4N0 or Stage III
- Tumor showing either mismatch repair proficient (MMRp) status by immunohistochemistry or microsatellite stable (MSS) or microsatellite instability-low (MSI-L) phenotype by PCR or next generation sequencing
- Provides fresh tumor tissue biopsy obtained during pre-screening or screening via colonoscopy
- Willing to use adequate contraception (male and/or female participants)
- Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1
- Adequate organ function
You will not qualify if you...
- Presence of distant metastatic disease
- Prior medical therapy for colon cancer including chemotherapy, immunotherapy, biologic, targeted therapy, radiation, or surgery
- Tumor not amenable to surgery or any surgical contraindications
- History of severe immune-mediated adverse events or neurologic immune-related events from prior immunotherapy
- History of exfoliative dermatitis including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, or DRESS syndrome
- History of myocarditis
- History of interstitial lung disease or immune-related pneumonitis
- Medical conditions, therapies, or lab abnormalities that could interfere with study participation or outcomes
- Poor medical risk due to serious uncontrolled disorders, systemic diseases, or active infections needing systemic therapy
- Treatment with investigational agents within 4 weeks before first study dose
- Pregnant or breastfeeding
- Severe allergic or anaphylactic reactions to chimeric, human, or humanized antibodies, fusion proteins, or known allergies to dostarlimab, CAPEOX components, or excipients
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 18 weeks
Participants receive neoadjuvant treatment with either dostarlimab plus CAPEOX chemotherapy or CAPEOX chemotherapy alone.
Visits as per chemotherapy and immunotherapy administration schedule
Duration - Up to approximately 105 weeks
Participants are monitored for adverse events and treatment outcomes after completing neoadjuvant therapy.
Visits scheduled for safety and outcome assessments
Trial Site Locations
Total: 33 locations
1
GSK Investigational Site
Aalst, Belgium, 9300
Actively Recruiting
2
GSK Investigational Site
Bonheiden, Belgium, 2820
Actively Recruiting
3
GSK Investigational Site
Brussels, Belgium, 1070
Actively Recruiting
4
GSK Investigational Site
Brussels, Belgium, 1200
Actively Recruiting
5
GSK Investigational Site
Ghent, Belgium, 9000
Actively Recruiting
6
GSK Investigational Site
Leuven, Belgium, 3000
Actively Recruiting
7
GSK Investigational Site
Liège, Belgium, 4000
Actively Recruiting
8
GSK Investigational Site
Liège, Belgium, 4000
Actively Recruiting
9
GSK Investigational Site
Ostend, Belgium, 8400
Actively Recruiting
10
GSK Investigational Site
Roeselare, Belgium, 8800
Actively Recruiting
11
GSK Investigational Site
Turnhout, Belgium, 2300
Actively Recruiting
12
GSK Investigational Site
Milan, Italy, 20162
Actively Recruiting
13
GSK Investigational Site
Roma, Italy, 00168
Actively Recruiting
14
GSK Investigational Site
Udine, Italy, 33100
Actively Recruiting
15
GSK Investigational Site
Osaka, Japan, 565-0871
Actively Recruiting
16
GSK Investigational Site
Osaka, Japan, 5731191
Actively Recruiting
17
GSK Investigational Site
Tokyo, Japan, 104-0045
Withdrawn
18
GSK Investigational Site
Tokyo, Japan, 135-8550
Actively Recruiting
19
GSK Investigational Site
Barcelona, Spain, 8025
Actively Recruiting
20
GSK Investigational Site
Barcelona, Spain, 8035
Actively Recruiting
21
GSK Investigational Site
Barcelona, Spain, 8036
Actively Recruiting
22
GSK Investigational Site
Madrid, Spain, 28007
Actively Recruiting
23
GSK Investigational Site
Madrid, Spain, 28034
Actively Recruiting
24
GSK Investigational Site
Madrid, Spain, 28041
Actively Recruiting
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
E
EU GSK Clinical Trials Call Center
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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