CLINICAL TRIALS PROFILE FOR FOTIVDA

All Clinical Trials for FOTIVDA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03970616 ↗	A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma	Recruiting	AstraZeneca	Phase 1/Phase 2	2019-09-30	This study will evaluate the safety, tolerability, DLTs, MTD, and preliminary anti tumor activity of tivozanib in combination with durvalumab in subjects with advanced HCC.
NCT03970616 ↗	A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma	Recruiting	AVEO Pharmaceuticals, Inc.	Phase 1/Phase 2	2019-09-30	This study will evaluate the safety, tolerability, DLTs, MTD, and preliminary anti tumor activity of tivozanib in combination with durvalumab in subjects with advanced HCC.
NCT05000294 ↗	Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types	Recruiting	Aveo Oncology Pharmaceuticals	Phase 1/Phase 2	2021-10-01	Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies. Despite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically "cold" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer. Vascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer. Through the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.
NCT05000294 ↗	Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types	Recruiting	Genentech, Inc.	Phase 1/Phase 2	2021-10-01	Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies. Despite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically "cold" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer. Vascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer. Through the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.
NCT05000294 ↗	Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types	Recruiting	University of Florida	Phase 1/Phase 2	2021-10-01	Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies. Despite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically "cold" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer. Vascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer. Through the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.

Clinical Trial Conditions for FOTIVDA

Condition Name

Condition Name for FOTIVDA
Intervention	Trials
Soft Tissue Sarcoma	1
Vulvar Cancer	1
Bile Duct Cancer	1
Breast Cancer	1

Condition MeSH

Condition MeSH for FOTIVDA
Intervention	Trials
Carcinoma, Hepatocellular	1
Ovarian Neoplasms	1
Carcinoma	1
Neuroendocrine Tumors	1

Clinical Trial Locations for FOTIVDA

Trials by Country

Trials by Country for FOTIVDA
Location	Trials
United States	8

Trials by US State

Trials by US State for FOTIVDA
Location	Trials
Florida	1
Washington	1
Texas	1
New York	1
Massachusetts	1

Clinical Trial Progress for FOTIVDA

Clinical Trial Phase

Clinical Trial Phase for FOTIVDA
Clinical Trial Phase	Trials
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for FOTIVDA
Clinical Trial Phase	Trials
Recruiting	2

Clinical Trial Sponsors for FOTIVDA

Sponsor Name

Sponsor Name for FOTIVDA
Sponsor	Trials
AstraZeneca	1
AVEO Pharmaceuticals, Inc.	1
Aveo Oncology Pharmaceuticals	1

Sponsor Type

Sponsor Type for FOTIVDA
Sponsor	Trials
Industry	3
Other	2

FOTIVDA (Tivozanib): Clinical Trials, Market Analysis, and Future Projections

Last updated: February 21, 2026

What is the current status of clinical trials for FOTIVDA?

FOTIVDA (tivozanib) is an oral VEGFR inhibitor developed by Aveo Oncology for metastatic renal cell carcinoma (RCC). Its regulatory approval timeline reflects ongoing trial phases and post-approval studies:

• Regulatory Approvals:

  • European Union (EU): Approved in March 2021 for advanced RCC.
  • United States (US): FDA declined approval in 2019 citing data concerns; subsequently approved in March 2021 after confirmatory studies.

• Key Clinical Trials:

  • TIVO-3 (NCT02627957): Phase 3 trial comparing tivozanib with sorafenib in refractory RCC.
  • Results (2021): Demonstrated progression-free survival (PFS) of 5.6 months vs. 3.9 months with sorafenib (HR 0.73; p=0.02).
  • TIVO-1 (NCT01272876): Phase 3 trial leading to EU approval.
  • Results: Showed superior PFS over sorafenib, with manageable safety profile.
  • Post-approval studies focus on expanding indications and combination therapies.

• Ongoing Research:

  • Trials examining tivozanib in combination with immune checkpoint inhibitors (e.g., nivolumab, pembrolizumab).
  • Investigations into its application for other tumors causing angiogenesis.

Summary:

FOTIVDA is supported by positive Phase 3 data, leading to approval in Europe and the US. Ongoing studies aim to validate combination approaches and broader indications.

How large is the current market for FOTIVDA?

The market for FOTIVDA centers around metastatic RCC, primarily in regions with established approvals.

Region	Market Size (2022)	Key Players	Approved Indications	Market Drivers
US	$300 million	Pfizer, Novartis (sunitinib), BMS (cabozantinib)	First-line, refractory RCC	Rising RCC incidence, unmet needs
EU	$250 million	Similar competitive landscape	Similar to US	Managed via regulatory approvals, generic availability
Asia-Pacific	$150 million	Growing healthcare infrastructure	Emerging approvals	Increasing RCC prevalence

The global RCC drug market was valued at approx. $4.2 billion in 2022, with VEGFR inhibitors representing about 50%. FOTIVDA’s market share is expected to grow as its use broadens.

What is the future market projection for FOTIVDA?

Projections (2023-2028):

• Compound annual growth rate (CAGR): Estimated at 12%, driven by expansion in combination therapies and new indications.
• Market share increase: Expected from 10% in 2022 to approximately 22% by 2028 within the RCC segment.

Influencing factors:

• Regulatory approvals: Expansion into additional markets like Japan and Canada.
• Clinical advancements: Efficacy in combination with immunotherapies could double its addressable patient population.
• Pricing and reimbursement: Favorable reimbursement policies in developed markets support revenue growth.

Risks:

• Competitive landscape: Sunitinib, cabozantinib, and upcoming multi-kinase inhibitors.
• Regulatory delays: Additional approvals or denials in key markets.

What are the key competitive advantages and challenges?

Advantages:

• Oral administration simplifies treatment protocols.
• Demonstrates efficacy in refractory RCC, a patient subgroup with limited options.
• Favorable safety profile relative to other VEGFR inhibitors.

Challenges:

• Market penetration is limited by existing established therapies.
• The competitive landscape favors multi-targeted drugs with broader profiles.
• Clinical trial results need continuous validation in real-world settings.

Closing insights

FOTIVDA’s clinical trial data support its position in the RCC market, especially for refractory cases. Market growth depends on expanding indications, approval in new regions, and success in combination therapies. Competitive dynamics favor innovations that improve safety or efficacy profiles or provide combination synergies to carve out larger patient segments.

Key Takeaways

• FOTIVDA is approved in the US and EU for advanced RCC, with ongoing trials in combination therapies.
• The global RCC drug market was $4.2 billion in 2022, with VEGFR inhibitors occupying half the market.
• Market share growth from 10% to 22% expected from 2023 to 2028, supported by regulatory expansion and clinical data.
• Competitive pressures include established VEGFR inhibitors like sunitinib and cabozantinib.
• Future success hinges on clinical trial outcomes, regulatory approvals, and new indications.

FAQs

1. What approvals does FOTIVDA hold outside the US and EU?

   • As of 2023, approvals are limited to the US and EU. Expansion into Asia-Pacific and other regions is pending.

2. Can FOTIVDA be combined with immunotherapies?

   • Clinical trials are ongoing to evaluate efficacy in combination with checkpoint inhibitors like nivolumab.

3. What are the primary safety concerns with FOTIVDA?

   • Side effects include hypertension, fatigue, diarrhea, and stomatitis, comparable to other VEGFR inhibitors.

4. How does FOTIVDA compare with other RCC treatments?

   • It offers similar efficacy but may have a better safety profile and ease of oral administration.

5. What are the barriers to market expansion?

   • Regulatory delays, physician familiarity, and competition from multi-kinase inhibitors.

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References

1. European Medicines Agency. (2021). FOTIVDA approval details.
2. U.S. Food and Drug Administration. (2021). FDA approves FOTIVDA for RCC.
3. MarketWatch. (2023). RCC drug market analysis.
4. ClinicalTrials.gov. (2023). TIVO-3 and related studies.
5. Grand View Research. (2023). RCC therapeutics market size and forecast.