Phase II Study of Avelumab Plus Intermittent Axitinib in Previously Untreated Patients With Metastatic Renal Cell Carcinoma (Tide-A Study) (TIDE-A)

NCT04698213 Phase 2 UNKNOWN

This study aims to test if patients achieving a tumor response with the combination of axitinib plus avelumab, can discontinued the axitinib in order to delay the resistance to the anti VEGFR-TKI and decrease the related toxicity of the combination therapy.

Details

Lead sponsor	Consorzio Oncotech
Phase	Phase 2
Status	UNKNOWN
Enrolment	75
Start date	2020-10-07
Completion	2024-10

Conditions

• Renal Carcinoma Metastatic

Interventions

• Axitinib Oral Tablet
• Avelumab

Primary outcomes

• Overall response rate (ORR) — From the date of the first study drugs administration until week 44
  Evaluate the rate of patients who have a partial response (PR) or complete response (CR) to the study treatment according to RECIST V. 1.1 criteria, as determined by investigator's assessments, at week 8 from axitinib discontinuation and avelumab maintenance, after 36 weeks of induction treatment with the combination of avelumab and axitinib.

Countries

Italy