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

Sponsor
GlaxoSmithKline
Study ID
NCT06567782
Phase
PHASE2
Status
Recruiting
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Conditions

  • Neoplasms, Colon

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dostarlimab — BIOLOGICAL
    Dostarlimab will be administered.
  • CAPEOX — DRUG
    CAPEOX chemotherapy consisting of capecitabine and oxaliplatin will be administered.

Study Details

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.

Key Dates

Start date
Feb 18, 2025
Status verified
May 2026
Primary completion
Nov 23, 2026
Completion
Oct 26, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dostarlimab plus CAPEOX
    Participants will receive dostarlimab plus CAPEOX (chemotherapy).
  • Active Comparator: CAPEOX
    Participants will receive CAPEOX (chemotherapy).

Primary Outcome Measure

Major pathological response (mPR) rate [ Time Frame: Up to approximately 18 weeks ]

Central Contacts

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