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Compares treatment options for Neoplasms, Colon
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
ClinicalTrials.gov ID: NCT06567782
What this study is testing
What is Dostarlimab?
Dostarlimab is an investigational medicine, being studied as a potential treatment for neoplasms, colon.
Also referred to as GSK4057190A, TSR-042.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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-
- MMR status: MMR status must be assessed by Immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where all proteins are...
- MSS or Microsatellite Instability-L (MSI-L) phenotype as determined by polymerase chain reaction (PCR) or by tissue next generation sequencing (NGS)...
You likely can't join if
- Has distant metastatic disease
- Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon...
- 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...
- 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...
See the full eligibility 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-
- 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
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aalst, Belgium
- Bonheiden, Belgium
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Liège, Belgium
- Ostend, Belgium
- Roeselare, Belgium
- Turnhout, Belgium
- Milan, Italy
- Roma, Italy
- Udine, Italy
- Osaka, Japan
- Tokyo, Japan
- Barcelona, Spain
- Madrid, Spain
- Oviedo, Spain
- Valencia, Spain
- Bern, Switzerland
- Geneva, Switzerland
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalst, Belgium; Bonheiden, Belgium; Brussels, Belgium; Ghent, Belgium; Leuven, Belgium; Liège, Belgium and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.