{
  "topic": {
    "stem": "PEMBROLIZUMAB_KIDNEY_ADJ_AUTO_2",
    "name": "Pembrolizumab adjuvant RCC (KEYNOTE-564)",
    "ncts": [
      "NCT05239728",
      "NCT05263609",
      "NCT04198766",
      "NCT04955743",
      "NCT05030506",
      "NCT03149822",
      "NCT05024318",
      "NCT02903914"
    ],
    "drug_patterns": [
      "pembrolizumab"
    ],
    "condition_patterns": [
      "renal cell"
    ]
  },
  "trials": [
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT05239728",
        "aact_title": "A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)",
        "aact_acronym": "",
        "start_date": "2022-03-15",
        "primary_completion_date": "2026-10-28",
        "aact_intvs": [
          "belzutifan",
          "pembrolizumab",
          "placebo"
        ],
        "aact_conditions": [
          "carcinoma, renal cell"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Disease-Free Survival (DFS)",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT05263609",
        "aact_title": "Optimizing Pembrolizumab Therapy With Timing and Intensification With Axitinib",
        "aact_acronym": "",
        "start_date": "2022-06-30",
        "primary_completion_date": "2026-06-30",
        "aact_intvs": [
          "axitinib",
          "pembrolizumab"
        ],
        "aact_conditions": [
          "renal cell cancer"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Proportion of Patient Response",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT04198766",
        "aact_title": "Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)",
        "aact_acronym": "",
        "start_date": "2019-12-10",
        "primary_completion_date": "2026-10-30",
        "aact_intvs": [
          "inbrx-106 - hexavalent ox40 agonist antibody",
          "pembrolizumab 200 mg",
          "pembrolizumab 400 mg"
        ],
        "aact_conditions": [
          "gastric cancer",
          "head and neck cancer",
          "melanoma"
        ],
        "pmid": "40404202",
        "pubmed_year": 2025,
        "pubmed_doi": "10.1136/jitc-2025-011524",
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT04955743",
        "aact_title": "Pembrolizumab and Lenvatinib in Patients With Brain Metastases From Melanoma or Renal Cell Carcinoma",
        "aact_acronym": "",
        "start_date": "2022-02-09",
        "primary_completion_date": "2025-05-28",
        "aact_intvs": [
          "pembrolizumab",
          "lenvatinib"
        ],
        "aact_conditions": [
          "brain metastases",
          "lenvatinib",
          "melanoma"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Best brain metastasis response rate (BMRR)",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT05030506",
        "aact_title": "A Study of Belzutifan (MK-6482) as Monotherapy and in Combination With Lenvatinib (E7080/MK-7902) With or Without Pembrolizumab (MK-3475) in China Participants With Advanced Renal Cell Carcinoma (MK-6482-010)",
        "aact_acronym": "",
        "start_date": "2021-10-13",
        "primary_completion_date": "2027-06-30",
        "aact_intvs": [
          "belzutifan",
          "pembrolizumab",
          "lenvatinib"
        ],
        "aact_conditions": [
          "renal cell carcinoma"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Number of participants who experienced dose-limiting toxicities (DLTs)",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03149822",
        "aact_title": "Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma",
        "aact_acronym": "",
        "start_date": "2017-09-28",
        "primary_completion_date": "2022-12-14",
        "aact_intvs": [
          "cabozantinib",
          "pembrolizumab"
        ],
        "aact_conditions": [
          "metastatic renal cell carcinoma"
        ],
        "pmid": "24504486",
        "pubmed_year": 2014,
        "pubmed_doi": "10.1007/s11864-013-0268-y",
        "aact_per_arm_counts": {
          "BG000": 5,
          "BG001": 3,
          "BG002": 37
        },
        "aact_primary_outcome_measure": "Efficacy of Pembrolizumab and Cabozantinib Based on Objective Response Rate",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "65.8"
          ],
          [
            "OG001",
            "0.0"
          ],
          [
            "OG000",
            "60.0"
          ],
          [
            "OG000",
            "0.0"
          ],
          [
            "OG001",
            "0.0"
          ],
          [
            "OG000",
            "97.4"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT05024318",
        "aact_title": "NeoAdjuvant Pembrolizumab and STEreotactic Radiotherapy Prior to Nephrectomy for Renal Cell Carcinoma",
        "aact_acronym": "NAPSTER",
        "start_date": "2022-02-08",
        "primary_completion_date": "2025-12-31",
        "aact_intvs": [
          "pembrolizumab",
          "stereotactic ablative radiotherapy",
          "nephrectomy"
        ],
        "aact_conditions": [
          "renal cell carcinoma, clear cell, somatic"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "mPR post-SABR with or without pembrolizumab",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT02903914",
        "aact_title": "Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors",
        "aact_acronym": "",
        "start_date": "2016-09-14",
        "primary_completion_date": "2020-04-30",
        "aact_intvs": [
          "incb001158",
          "pembrolizumab"
        ],
        "aact_conditions": [
          "bladder cancer",
          "colorectal cancer (crc)",
          "gastric cancer"
        ],
        "pmid": "39886141",
        "pubmed_year": 2024,
        "pubmed_doi": "10.1136/bmjonc-2023-000249",
        "aact_per_arm_counts": {
          "BG000": 8,
          "BG001": 7,
          "BG002": 85,
          "BG003": 7,
          "BG004": 10,
          "BG005": 14,
          "BG006": 123,
          "BG007": 6
        },
        "aact_primary_outcome_measure": "Number of Participants With Any Treatment-emergent Adverse Event (TEAE)",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "7.0"
          ],
          [
            "OG001",
            "7.0"
          ],
          [
            "OG002",
            "81.0"
          ],
          [
            "OG003",
            "7.0"
          ],
          [
            "OG004",
            "10.0"
          ],
          [
            "OG005",
            "13.0"
          ],
          [
            "OG006",
            "123.0"
          ],
          [
            "OG007",
            "6.0"
          ],
          [
            "OG000",
            "100.0"
          ],
          [
            "OG000",
            "100.0"
          ]
        ]
      }
    }
  ],
  "n_total": 8,
  "n_pass_all": 2,
  "verdict": "VIABLE",
  "pass_rate": 0.25
}