{
"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": [
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "Stage II to III (T3-T4, N0, or T any, N+)",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"Stage II",
"Stage III"
]
}
},
{
"exact_snippets": "locally advanced rectal cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "locally advanced rectal cancer"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "histologically confirmed",
"criterion": "histological confirmation",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "Stage II to III (T3-T4, N0, or T any, N+)",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"Stage II",
"Stage III"
]
}
}
]
},
{
"exact_snippets": "locally advanced rectal cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "locally advanced rectal cancer"
}
}
]
}
]
}
},
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"line": "* Participant has radiologically and endoscopically evaluable disease.",
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{
"exact_snippets": "radiologically and endoscopically evaluable disease",
"criterion": "disease evaluation",
"requirement": {
"requirement_type": "method",
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"radiologically",
"endoscopically"
]
}
}
]
},
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"criterion": "disease evaluation",
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"expected_value": [
"radiologically",
"endoscopically"
]
}
}
]
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "categorization",
"expected_value": "dMMR"
}
},
{
"exact_snippets": "tumor which can be categorized as ... MSI-H",
"criterion": "tumor MSI-H status",
"requirement": {
"requirement_type": "categorization",
"expected_value": "MSI-H"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "tumor which can be categorized as dMMR",
"criterion": "tumor dMMR status",
"requirement": {
"requirement_type": "categorization",
"expected_value": "dMMR"
}
},
{
"exact_snippets": "tumor which can be categorized as ... MSI-H",
"criterion": "tumor MSI-H status",
"requirement": {
"requirement_type": "categorization",
"expected_value": "MSI-H"
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
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"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Participant has distant metastatic disease.",
"criterions": [
{
"exact_snippets": "distant metastatic disease",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "location",
"expected_value": "distant"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "distant metastatic disease",
"criterion": "metastatic disease",
"requirement": {
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"expected_value": "distant"
}
}
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Participant has received prior ... systemic therapy",
"criterion": "prior systemic therapy",
"requirement": {
"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",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"or_criteria": [
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"exact_snippets": "Participant has received prior radiation therapy",
"criterion": "prior radiation therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Participant has received prior ... systemic therapy",
"criterion": "prior systemic therapy",
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}
},
{
"exact_snippets": "Participant has received prior ... surgery for management of rectal cancer",
"criterion": "prior surgery for management of rectal cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Participant has any history of interstitial lung disease or pneumonitis",
"criterions": [
{
"exact_snippets": "history of interstitial lung disease",
"criterion": "interstitial lung disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of ... pneumonitis",
"criterion": "pneumonitis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
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"exact_snippets": "history of interstitial lung disease",
"criterion": "interstitial lung disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of ... pneumonitis",
"criterion": "pneumonitis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"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)",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Participant has experienced any of the following with prior immunotherapy: ... myocarditis of any grade",
"criterion": "myocarditis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"expected_value": true
}
}
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"exact_snippets": "Participant has experienced any of the following with prior immunotherapy: ... myocarditis of any grade",
"criterion": "myocarditis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
},
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"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": [
{
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"expected_value": true
}
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"value": 2,
"unit": "years"
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}
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"requirement": {
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}
}
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"and_criteria": [
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"value": 2,
"unit": "years"
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}
}
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"other in situ cancers"
]
}
}
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"else_criteria": null
}
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{
"identified_line": {
"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": [
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"expected_value": true
}
},
{
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}
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"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",
"requirement": {
"requirement_type": "consideration as systemic treatment",
"expected_value": false
}
}
]
},
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"and_criteria": [
{
"and_criteria": [
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"exact_snippets": "Participant has an active autoimmune disease",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "has required systemic treatment in the past 2 years",
"criterion": "systemic treatment for autoimmune disease",
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}
}
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"requirement": {
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}
}
}
]
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},
{
"identified_line": {
"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",
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"expected_value": true
}
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}
},
{
"exact_snippets": "history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins",
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"expected_value": true
}
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"exact_snippets": "known allergies to dostarlimab or its excipients",
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}
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"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
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"exact_snippets": "history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins",
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"exact_snippets": "history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins",
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"expected_value": true
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"exact_snippets": "known allergies to dostarlimab or its excipients",
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"identified_line": {
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{
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}
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}
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{
"exact_snippets": "uses donor stem cells (allogeneic stem cell transplant)",
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}
}
]
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"and_criteria": [
{
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}
},
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"exact_snippets": "uses donor stem cells (allogeneic stem cell transplant)",
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}
}
]
}
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}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}