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Phase II study of axitinib intensification plus standard of care (SOC) compared to SOC alone after induction with nivolumab plus ipilimumab in mRCC patients without previous complete response (AxIn study).

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511397-70-00
Acronym
AxIn
Enrollment
178
Registered
2024-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-12

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

Conditions

metastatic renal cell carcinoma (mRCC)

Brief summary

• To evaluate the overall response rate in patients treated with the axitinib in addiction to SOC compared to SOC alone.

Detailed description

• To evaluate the efficacy of axitinib in addiction to SOC compared to SOC alone in terms of: a) Progression free survival b) Overall survival c) Depth of response d) Duration of response e) Quality of life • To evaluate the safety of axitinib in addiction to SOC compared to SOC alone

Interventions

DRUGAXITINIB

Sponsors

Consorzio Oncotech
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
• To evaluate the overall response rate in patients treated with the axitinib in addiction to SOC compared to SOC alone.

Secondary

MeasureTime frame
• To evaluate the efficacy of axitinib in addiction to SOC compared to SOC alone in terms of: a) Progression free survival b) Overall survival c) Depth of response d) Duration of response e) Quality of life • To evaluate the safety of axitinib in addiction to SOC compared to SOC alone

Countries

Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026