A Randomized, Open-Label, Phase II Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Patients with Previously Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505816-39-00

Acronym

BO43936

Enrollment

113

Registered

2024-04-11

Start date

2023-04-04

Completion date

Unknown

Last updated

2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma

Brief summary

1. Incidence and severity of adverse events, with severity graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. with the exception of cytokine release syndrome (CRS) event severity which will be determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading scale

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Incidence and severity of adverse events, with severity graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. with the exception of cytokine release syndrome (CRS) event severity which will be determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading scale	—

Countries

France, Germany, Poland, Spain

Outcome results