{
    "info": {
        "nct_id": "NCT05723562",
        "official_title": "A Phase 2, Single-Arm, Open-Label Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer",
        "inclusion_criteria": "* Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal cancer\n* Participant has radiologically and endoscopically evaluable disease.\n* Participant has a tumor which can be categorized as dMMR or MSI-H by local or central assessment\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Participant has distant metastatic disease.\n* Participant has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer.\n* Participant has any history of interstitial lung disease or pneumonitis\n* Participant has experienced any of the following with prior immunotherapy: any irAE of Grade ≥3, immune-related 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, toxic epidermal necrolysis, or DRESS syndrome), or myocarditis of any grade. Non clinically significant laboratory abnormalities are not exclusionary.\n* Participant has a known additional malignancy that progressed or required active treatment within the past 2 years. Exceptions include adequately treated superficial skin cancers, superficial bladder cancers, and other in situ cancers.\n* Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.\n* Participant has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or has known allergies to dostarlimab or its excipients.\n* Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant).",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal cancer",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed",
                    "criterion": "histological confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage II to III (T3-T4, N0, or T any, N+)",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "Stage II",
                                "Stage III"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced rectal cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "locally advanced rectal cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has radiologically and endoscopically evaluable disease.",
            "criterions": [
                {
                    "exact_snippets": "radiologically and endoscopically evaluable disease",
                    "criterion": "disease evaluation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "radiologically",
                                "endoscopically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has a tumor which can be categorized as dMMR or MSI-H by local or central assessment",
            "criterions": [
                {
                    "exact_snippets": "tumor which can be categorized as dMMR",
                    "criterion": "tumor dMMR status",
                    "requirements": [
                        {
                            "requirement_type": "categorization",
                            "expected_value": "dMMR"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor which can be categorized as ... MSI-H",
                    "criterion": "tumor MSI-H status",
                    "requirements": [
                        {
                            "requirement_type": "categorization",
                            "expected_value": "MSI-H"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Participant has distant metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "distant metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "distant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer.",
            "criterions": [
                {
                    "exact_snippets": "Participant has received prior radiation therapy",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant has received prior ... systemic therapy",
                    "criterion": "prior systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant has received prior ... surgery for management of rectal cancer",
                    "criterion": "prior surgery for management of rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has any history of interstitial lung disease or pneumonitis",
            "criterions": [
                {
                    "exact_snippets": "history of interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... pneumonitis",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has experienced any of the following with prior immunotherapy: any irAE of Grade ≥3, immune-related 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, toxic epidermal necrolysis, or DRESS syndrome), or myocarditis of any grade. Non clinically significant laboratory abnormalities are not exclusionary.",
            "criterions": [
                {
                    "exact_snippets": "Participant has experienced any of the following with prior immunotherapy: any irAE of Grade ≥3",
                    "criterion": "irAE (immune-related adverse event)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant has experienced any of the following with prior immunotherapy: ... immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse myelitis)",
                    "criterion": "immune-related severe neurologic events",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant has experienced any of the following with prior immunotherapy: ... exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or DRESS syndrome)",
                    "criterion": "exfoliative dermatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant has experienced any of the following with prior immunotherapy: ... myocarditis of any grade",
                    "criterion": "myocarditis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has a known additional malignancy that progressed or required active treatment within the past 2 years. Exceptions include adequately treated superficial skin cancers, superficial bladder cancers, and other in situ cancers.",
            "criterions": [
                {
                    "exact_snippets": "Participant has a known additional malignancy",
                    "criterion": "additional malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "progressed or required active treatment within the past 2 years",
                    "criterion": "additional malignancy progression or treatment",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Exceptions include adequately treated superficial skin cancers, superficial bladder cancers, and other in situ cancers",
                    "criterion": "exceptions for additional malignancy",
                    "requirements": [
                        {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "adequately treated superficial skin cancers",
                                "superficial bladder cancers",
                                "other in situ cancers"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.",
            "criterions": [
                {
                    "exact_snippets": "Participant has an active autoimmune disease",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has required systemic treatment in the past 2 years",
                    "criterion": "systemic treatment for autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 2 years"
                        }
                    ]
                },
                {
                    "exact_snippets": "Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment",
                    "criterion": "replacement therapy",
                    "requirements": [
                        {
                            "requirement_type": "consideration as systemic treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or has known allergies to dostarlimab or its excipients.",
            "criterions": [
                {
                    "exact_snippets": "history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins",
                    "criterion": "allergic and/or anaphylactic reactions",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "substances",
                            "expected_value": [
                                "chimeric antibodies",
                                "human antibodies",
                                "humanized antibodies",
                                "fusion proteins"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "known allergies to dostarlimab or its excipients",
                    "criterion": "allergies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "substances",
                            "expected_value": [
                                "dostarlimab",
                                "its excipients"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant).",
            "criterions": [
                {
                    "exact_snippets": "Has received ... an organ or stem cell transplant",
                    "criterion": "organ or stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "plans to receive an organ or stem cell transplant",
                    "criterion": "organ or stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "planned receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uses donor stem cells (allogeneic stem cell transplant)",
                    "criterion": "allogeneic stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "donor type",
                            "expected_value": "allogeneic"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}