A Phase 2 interventional study of Ivonescimab (dose level 1) combined with Cadonilimab and Ivonescimab (dose level 2) combined with Cadonilimab in Renal Cell Carcinoma, Clear Cell, sponsored by Summit Therapeutics. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Summit Therapeutics · Phase 2, Interventional, and Treatment
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.
1,992 studies on the registry are indexed under Carcinoma, Renal Cell; 387 are open to participants now.
This study's planned enrollment of 100 is above the median of 42 across 1,501 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Summit Therapeutics is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Ivonescimab (dose level 1) + Cadonilimab
Drug: Ivonescimab (dose level 1) combined with Cadonilimab
Ivonescimab (dose level 2) + Cadonilimab
Drug: Ivonescimab (dose level 2) combined with Cadonilimab
Ivonescimab + Ipilimumab
Drug: Ivonescimab combined with Ipilimumab
Ivonescimab
Drug: Ivonescimab
Nivolumab + Ipilimumab
Drug: Nivolumab combined with Ipilimumab
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.
Objective Response Rate (ORR)
ORR per RECIST v1.1 by investigator
Time frame: From randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Adverse Events (AEs)
Adverse events (AEs) as characterized by type, incidence, severity, seriousness, and relationship to study treatment
Time frame: At the time of initiation of the first dose through 90 days after the last dose of study treatment.
Disease Control Rate (DCR)
DCR assessed by investigator according to RECIST v1.1.
Time frame: From randomization to first occurrence of disease progression, death or study completion, whichever came first, assessed up to 3 years.
Duration of Response (DoR)
Duration of response (DoR) assessed by investigator according to RECIST v1.1.
Time frame: From time of first recorded response randomization to progressive disease, or death or study completion, whichever came first, assessed up to 3 years.
Progression Free Survival (PFS)
Progression Free Survival (PFS) is defined as the time from randomization to the first documented disease progression (per RECIST v1.1) assessed by investigator or death due to any cause, whichever occurs first.
Time frame: From randomization to progressive disease or death, whichever came first, assessed up to 3 years.
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
Time frame: From randomization to death, assessed up to 4 years.
Pharmacokinetics (PK)
Serum drug concentration at different time points after administration
Time frame: From first dose of study drug until end of treatment, assessed up to 3 years.
Anti-Drug Antibodies (ADA)
Number of subjects with detectable anti-drug antibodies (ADA).
Time frame: From time of initiation of first dose to 30 days after end of treatment.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ivonescimab
Summit Therapeutics