Testing a new treatment for colon cancer using dostarlimab and chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of combining dostarlimab with the chemotherapy regimen CAPEOX (capecitabine and oxaliplatin) as a neoadjuvant treatment for patients with untreated T4N0 or Stage III mismatch repair proficient/microsatellite stable (MMRp/MSS) colon cancer. Participants will receive this combination therapy before any surgical intervention, with the goal of determining if it leads to better outcomes compared to CAPEOX alone. The study will also assess specific biomarkers in blood and tumor samples to predict treatment response and enhance understanding of dostarlimab's role in the therapeutic process.

Why it matters

Who can join: the full rules

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 Microsatellite Instability-L (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

Where it's running

• GSK Investigational Site
  Aalst, Belgium Recruiting
• GSK Investigational Site
  Bonheiden, Belgium Recruiting
• GSK Investigational Site
  Brussels, Belgium Recruiting
• GSK Investigational Site
  Brussels, Belgium Recruiting
• GSK Investigational Site
  Ghent, Belgium Recruiting
• GSK Investigational Site
  Leuven, Belgium Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating dostarlimab for resectable colon cancer

  This study is testing if adding a new immunotherapy called dostarlimab to standard chemotherapy can help people with certain types of resectable colon cancer do better.

  Recruiting at 229 sites Phase 3 GlaxoSmithKline · Tucson, Arizona and 265 other locations · NCT05855200

• Testing a B7‑H3 antibody–drug conjugate alone and with dostarlimab in recurrent/metastatic head and neck squamous cell carcinoma

  It tests an antibody–drug conjugate called GSK5764227 by itself or with the immunotherapy dostarlimab in adults with recurrent or metastatic head and neck squamous cell carcinoma who have received prior treatments.

  Recruiting Phase 2 University Health Network, Toronto · Toronto, Ontario · NCT07408063

• Dostarlimab with cisplatin, etoposide, and radiotherapy for small cell neuroendocrine cervical cancer

  This trial will test whether adding the immunotherapy drug dostarlimab to cisplatin/etoposide chemotherapy plus radiotherapy helps women with small cell neuroendocrine cervical carcinoma stay progression-free longer.

  Recruiting Phase 2 Chang Gung Memorial Hospital · Taoyuan, Taiwan · NCT07336147

• Neoadjuvant dostarlimab for locally advanced dMMR/MSI‑H rectal cancer in routine practice

  This project will try neoadjuvant dostarlimab in adults with dMMR/MSI‑H stage II–III rectal cancer to see how well it works and how safe it is in real-world clinical care.

  Recruiting National Cancer Institute, Naples · Naples and 1 other locations · NCT07269249

• Dostarlimab with carboplatin–paclitaxel for advanced or recurrent endometrial cancer in Chinese patients with dMMR/MSI-H

  This Phase 2 trial will test whether adding dostarlimab to carboplatin and paclitaxel helps Chinese patients with advanced or recurrent dMMR/MSI‑H endometrial cancer respond to treatment and tolerate the combination.

  Recruiting Phase 2 GlaxoSmithKline · Jinan, Shandong · NCT07108270

• Neoadjuvant dostarlimab before surgery for resectable stage III pMMR/MSS colon cancer

  This will test whether two pre-surgery infusions of the PD-1 drug dostarlimab help people with resectable stage III pMMR/MSS colon cancer.

  Recruiting Phase 2 Universitaire Ziekenhuizen KU Leuven · Leuven · NCT06830239

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.