Summit Therapeutics
This study aims to evaluate the safety and efficacy of Ivonescimab alone or in combination with Cadonilimab or Ipilimumab in the treatment of advanced clear cell renal cell carcinoma (ccRCC).
This is a multiregional, randomized, open-label Phase II clinical study to evaluate the safety and efficacy of Ivonescimab alone or in combination with Cadonilimab or Ipilimumab in the treatment of advanced clear cell renal cell carcinoma (ccRCC). Approximately 100 participants will be randomized across five treatment arms: ivonescimab in combination with cadonilimab, ivonescimab in combination with ipilimumab, ivonescimab monotherapy, or nivolumab in combination with ipilimumab.
Inclusion Criteria: 1. Able to understand and voluntarily sign a written informed consent form, which must be signed prior to the performance of the designated study procedures required by the study. 2. Age ≥ 18 years both male and female. 3. Karnofsky Performance Status Score (KPS) ≥ 70%. 4. Expected survival ≥ 6 months. 5. According to RECIST v1.1, there is at least one measurable lesion that is suitable for repeated and accurate measurements. 6. Histologically or cytologically, pathologically confirmed renal cancer with a clear cell carcinoma component (ccRCC). 7. Locally advanced or metas…
Subjects will receive Ivonescimab (dose level 1) combined with Cadonilimab via intravenous infusion (IV) up to 2 years.
Ivonescimab (dose level 2) combined with Cadonilimab via intravenous infusion (IV) up to 2 years.
Ivonescimab combined with Ipilimumab via intravenous infusion (IV) up to 4 cycles. Afterward, Ivonescimab for maintenance treatment up to 2 years total.
Ivonescimab monotherapy via intravenous infusion (IV) up to 2 years.
Nivolumab combined with Ipilimumab via intravenous infusion (IV) up to 4 cycles. Afterward, Nivolumab will be used for maintenance treatment up to 2 years total.
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