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NCT06567782 | NOT YET RECRUITING | Neoplasms, Colon

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

Brief 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.

Condition or disease

Neoplasms, Colon

Intervention/treatment

Dostarlimab

CAPEOX

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2024-12-05
Estimated Primary Completion Date : 2028-09-07
Estimated Study Completion Date : 2028-09-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
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

Location Details

NCT06567782

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Belgium,

GSK Investigational Site

Aalst, Belgium, 9300

Not yet recruiting

Belgium,

GSK Investigational Site

Bonheiden, Belgium, 2820

Not yet recruiting

Belgium,

GSK Investigational Site

Bruxelles, Belgium, 1070

Not yet recruiting

Belgium,

GSK Investigational Site

Bruxelles, Belgium, 1200

Not yet recruiting

Belgium,

GSK Investigational Site

Gent, Belgium, 9000

Not yet recruiting

Belgium,

GSK Investigational Site

Leuven, Belgium, 3000

Not yet recruiting

Belgium,

GSK Investigational Site

LiEge, Belgium, 4000

Not yet recruiting

Belgium,

GSK Investigational Site

Liege, Belgium, 4000

Not yet recruiting

Belgium,

GSK Investigational Site

Roeselare, Belgium, 8800

Not yet recruiting

Spain,

GSK Investigational Site

Barcelona, Spain, 8035

Not yet recruiting

Spain,

GSK Investigational Site

Madrid, Spain, 28222

Not yet recruiting

United Kingdom,

GSK Investigational Site

Glasgow, United Kingdom, G12 0YN

Not yet recruiting

United Kingdom,

GSK Investigational Site

Leeds West Yorkshire, United Kingdom, LS9 7TF

Not yet recruiting

United Kingdom,

GSK Investigational Site

London, United Kingdom, NW1 2PG

Not yet recruiting

United Kingdom,

GSK Investigational Site

Sutton, United Kingdom, SM2 5PT