{
    "info": {
        "nct_id": "NCT06567782",
        "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",
        "inclusion_criteria": "* Has untreated pathologically confirmed colon adenocarcinoma\n* Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III\n* Has a tumor demonstrating the presence of either-\n\n  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\n  2. MSS or MSI-L phenotype as determined by polymerase chain reaction (PCR) or by tissue next generation sequencing (NGS), determined by local laboratory\n* Provides fresh tumor tissue obtained during either the pre-screening or screening period via colonoscopy performed per procedure manual. Tissue biopsy is required\n* Is willing to use adequate contraception male and/or female participants\n* Has an Eastern Cooperative Oncology Group - Performance status (ECOG-PS) of 0 or 1\n* Has adequate organ function\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Has distant metastatic disease\n* Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer\n* Has, in the investigator's opinion, a tumor that is not amenable to surgery or has any other contraindication to surgery\n* 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\n* Has any history of interstitial lung disease or immune-related pneumonitis\n* 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\n* 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\n* Has received treatment with an investigational agent within [4 weeks] of the first dose of study intervention\n* Is pregnant or breastfeeding\n* 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",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Has untreated pathologically confirmed colon adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "untreated pathologically confirmed colon adenocarcinoma",
                    "criterion": "colon adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        },
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "pathologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III",
            "criterions": [
                {
                    "exact_snippets": "resectable colon adenocarcinoma",
                    "criterion": "colon adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically T4N0",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T4N0"
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage III",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "Stage III"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a tumor demonstrating the presence of either-",
            "criterions": [
                {
                    "exact_snippets": "Has a tumor",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "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",
            "criterions": [
                {
                    "exact_snippets": "MMR status: MMR status must be assessed by Immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2)",
                    "criterion": "MMR status",
                    "requirements": [
                        {
                            "requirement_type": "assessment method",
                            "expected_value": "Immunohistochemistry (IHC)"
                        },
                        {
                            "requirement_type": "proteins",
                            "expected_value": [
                                "MLH1",
                                "MSH2",
                                "MSH6",
                                "PMS2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "MMR status: ... where all proteins are present indicates MMRp",
                    "criterion": "MMR status",
                    "requirements": [
                        {
                            "requirement_type": "protein presence",
                            "expected_value": "all proteins present indicates MMRp"
                        }
                    ]
                },
                {
                    "exact_snippets": "MMR status: ... MMR status may be determined local laboratory",
                    "criterion": "MMR status",
                    "requirements": [
                        {
                            "requirement_type": "determination location",
                            "expected_value": "local laboratory"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. MSS or MSI-L phenotype as determined by polymerase chain reaction (PCR) or by tissue next generation sequencing (NGS), determined by local laboratory",
            "criterions": [
                {
                    "exact_snippets": "MSS or MSI-L phenotype",
                    "criterion": "phenotype",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "MSS",
                                "MSI-L"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "determined by polymerase chain reaction (PCR) or by tissue next generation sequencing (NGS)",
                    "criterion": "determination method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "polymerase chain reaction (PCR)",
                                "tissue next generation sequencing (NGS)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "determined by local laboratory",
                    "criterion": "determination location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "local laboratory"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Provides fresh tumor tissue obtained during either the pre-screening or screening period via colonoscopy performed per procedure manual. Tissue biopsy is required",
            "criterions": [
                {
                    "exact_snippets": "fresh tumor tissue obtained during either the pre-screening or screening period via colonoscopy",
                    "criterion": "fresh tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue biopsy is required",
                    "criterion": "tissue biopsy",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": "required"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Is willing to use adequate contraception male and/or female participants",
            "criterions": [
                {
                    "exact_snippets": "willing to use adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has an Eastern Cooperative Oncology Group - Performance status (ECOG-PS) of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group - Performance status (ECOG-PS) of 0 or 1",
                    "criterion": "ECOG-PS",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has adequate organ function",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Has distant metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "distant metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": "distant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer",
            "criterions": [
                {
                    "exact_snippets": "Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy)",
                    "criterion": "prior medical therapy",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "chemotherapy",
                                "immunotherapy",
                                "biologic",
                                "targeted therapy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior ... radiation therapy",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior ... surgery for management of colon cancer",
                    "criterion": "prior surgery for colon cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has, in the investigator's opinion, a tumor that is not amenable to surgery or has any other contraindication to surgery",
            "criterions": [
                {
                    "exact_snippets": "tumor that is not amenable to surgery",
                    "criterion": "tumor amenability to surgery",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any other contraindication to surgery",
                    "criterion": "contraindication to surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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",
            "criterions": [
                {
                    "exact_snippets": "Has experienced any of the following with prior immunotherapy: any imAE ≥ Grade 3",
                    "criterion": "immune-related adverse event (imAE)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Has experienced any of the following with prior immunotherapy: ... immune-mediated severe neurologic events of any-grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse myelitis)",
                    "criterion": "immune-mediated severe neurologic events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "any-grade"
                        }
                    ]
                },
                {
                    "exact_snippets": "Has experienced any of the following with prior immunotherapy: ... exfoliative dermatitis of any grade [Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), or Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome]",
                    "criterion": "exfoliative dermatitis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "any grade"
                        }
                    ]
                },
                {
                    "exact_snippets": "Has experienced any of the following with prior immunotherapy: ... myocarditis of any grade",
                    "criterion": "myocarditis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "any grade"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has any history of interstitial lung disease or immune-related pneumonitis",
            "criterions": [
                {
                    "exact_snippets": "history of interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... immune-related pneumonitis",
                    "criterion": "immune-related pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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",
            "criterions": [
                {
                    "exact_snippets": "Has a history or current evidence of any medical condition",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "therapy",
                    "criterion": "therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormality",
                    "criterion": "laboratory abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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",
            "criterions": [
                {
                    "exact_snippets": "poor medical risk due to a serious, uncontrolled medical disorder",
                    "criterion": "medical disorder",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "poor medical risk due to a ... non-malignant systemic disease",
                    "criterion": "systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "malignancy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "poor medical risk due to a ... active infection requiring systemic therapy",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received treatment with an investigational agent within [4 weeks] of the first dose of study intervention",
            "criterions": [
                {
                    "exact_snippets": "Has received treatment with an investigational agent within [4 weeks]",
                    "criterion": "treatment with an investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Is pregnant or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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",
            "criterions": [
                {
                    "exact_snippets": "Has a history of severe allergic and/or anaphylactic reactions to chimeric, human, or humanized antibodies, fusion proteins",
                    "criterion": "severe allergic and/or anaphylactic reactions",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "substances",
                            "expected_value": [
                                "chimeric antibodies",
                                "human antibodies",
                                "humanized antibodies",
                                "fusion proteins"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "known allergies to dostarlimab, or its excipients",
                    "criterion": "allergies to dostarlimab or its excipients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known allergies to ... any components of CAPEOX",
                    "criterion": "allergies to components of CAPEOX",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}