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NCT04987203

Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma

Active, enrolled Phase 3 Last updated 22 August 2025
What this trial tests

Phase 3 trial testing Tivozanib in Renal Cell Carcinoma in 343 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
9 September 2021
Primary endpoint
30 September 2025
30 December 2025

Quick facts

Lead sponsorAVEO Pharmaceuticals, Inc.
PhasePhase 3
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment343
Start date9 September 2021
Primary completion30 September 2025
Estimated completion30 December 2025
Sites139 locations across France, Italy, Belgium, Chile, United Kingdom, Germany, Poland, Mexico

Drugs / interventions tested

Conditions studied

Sponsor

AVEO Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 130, any sex, with Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Tumor immunotherapies by immune checkpoint inhibitors (ICIs); the pros and cons.
    Naimi A, Mohammed RN, Raji A, Chupradit S, et al · · 2022 · cited 350× · PMID 35392976 · DOI 10.1186/s12964-022-00854-y
  2. The Evasion Mechanisms of Cancer Immunity and Drug Intervention in the Tumor Microenvironment.
    Kim SK, Cho SW. · · 2022 · cited 300× · PMID 35685630 · DOI 10.3389/fphar.2022.868695
  3. Treatment Landscape of Renal Cell Carcinoma.
    Chen YW, Wang L, Panian J, Dhanji S, et al · · 2023 · cited 87× · PMID 38153686 · DOI 10.1007/s11864-023-01161-5
  4. Tivozanib plus nivolumab versus tivozanib monotherapy in patients with renal cell carcinoma following an immune checkpoint inhibitor: results of the phase 3 TiNivo-2 Study.
    Choueiri TK, Albiges L, Barthélémy P, Iacovelli R, et al · · 2024 · cited 54× · PMID 39284329 · DOI 10.1016/s0140-6736(24)01758-6
  5. Emerging Trends in Immunotherapy for Cancer.
    Mishra AK, Ali A, Dutta S, Banday S, et al · · 2022 · cited 41× · PMID 36135216 · DOI 10.3390/diseases10030060
  6. Rationale of using immune checkpoint inhibitors (ICIs) and anti-angiogenic agents in cancer treatment from a molecular perspective.
    Sherafat NS, Keshavarz A, Mardi A, Mohammadiara A, et al · · 2025 · cited 40× · PMID 40629032 · DOI 10.1007/s10238-025-01751-7
  7. Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
    Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898
  8. Renal cancer: signaling pathways and advances in targeted therapies.
    Jiang A, Li J, He Z, Liu Y, et al · · 2024 · cited 18× · PMID 39092291 · DOI 10.1002/mco2.676

Verify or expand the search:

Other trials of Tivozanib

Trials testing the same drug.

Other recruiting trials for Renal Cell Carcinoma

Currently open trials in the same condition.

Other AVEO Pharmaceuticals, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04987203.

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