CLINICAL TRIALS PROFILE FOR BAVENCIO

All Clinical Trials for BAVENCIO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02584829 ↗	Localized Radiation Therapy or Recombinant Interferon Beta and Avelumab With or Without Cellular Adoptive Immunotherapy in Treating Patients With Metastatic Merkel Cell Carcinoma	Active, not recruiting	EMD Serono	Phase 1/Phase 2	2015-11-06	This phase I/II trial studies the side effects and how well localized radiation therapy or recombinant interferon beta and avelumab with or without cellular adoptive immunotherapy works in treating patients with Merkel cell carcinoma that has spread to other parts of the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Interferon beta is a substance that can improve the body's natural response and may interfere with the growth of tumor cells. Monoclonal antibodies, such as avelumab, may help T lymphocytes kill tumor cells. For cellular adoptive immunotherapy, specific white blood cells are collected from the patient's blood and treated in the laboratory to recognize Merkel cell carcinoma. Infusing these cells back into the patient may help the body build an effective immune response to kill Merkel cell carcinoma. Giving localized radiation therapy or recombinant interferon beta and avelumab with or without cellular adoptive immunotherapy may be a better treatment for Merkel cell carcinoma.
NCT02584829 ↗	Localized Radiation Therapy or Recombinant Interferon Beta and Avelumab With or Without Cellular Adoptive Immunotherapy in Treating Patients With Metastatic Merkel Cell Carcinoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2015-11-06	This phase I/II trial studies the side effects and how well localized radiation therapy or recombinant interferon beta and avelumab with or without cellular adoptive immunotherapy works in treating patients with Merkel cell carcinoma that has spread to other parts of the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Interferon beta is a substance that can improve the body's natural response and may interfere with the growth of tumor cells. Monoclonal antibodies, such as avelumab, may help T lymphocytes kill tumor cells. For cellular adoptive immunotherapy, specific white blood cells are collected from the patient's blood and treated in the laboratory to recognize Merkel cell carcinoma. Infusing these cells back into the patient may help the body build an effective immune response to kill Merkel cell carcinoma. Giving localized radiation therapy or recombinant interferon beta and avelumab with or without cellular adoptive immunotherapy may be a better treatment for Merkel cell carcinoma.
NCT02584829 ↗	Localized Radiation Therapy or Recombinant Interferon Beta and Avelumab With or Without Cellular Adoptive Immunotherapy in Treating Patients With Metastatic Merkel Cell Carcinoma	Active, not recruiting	Fred Hutchinson Cancer Research Center	Phase 1/Phase 2	2015-11-06	This phase I/II trial studies the side effects and how well localized radiation therapy or recombinant interferon beta and avelumab with or without cellular adoptive immunotherapy works in treating patients with Merkel cell carcinoma that has spread to other parts of the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Interferon beta is a substance that can improve the body's natural response and may interfere with the growth of tumor cells. Monoclonal antibodies, such as avelumab, may help T lymphocytes kill tumor cells. For cellular adoptive immunotherapy, specific white blood cells are collected from the patient's blood and treated in the laboratory to recognize Merkel cell carcinoma. Infusing these cells back into the patient may help the body build an effective immune response to kill Merkel cell carcinoma. Giving localized radiation therapy or recombinant interferon beta and avelumab with or without cellular adoptive immunotherapy may be a better treatment for Merkel cell carcinoma.
NCT02859454 ↗	Avelumab for People With Recurrent Respiratory Papillomatosis	Completed	National Cancer Institute (NCI)	Phase 2	2016-08-06	Background: Recurrent respiratory papillomatosis (RRP) is a rare disease caused by human papillomavirus. It can cause voice changes, airway compromise, pulmonary lesions, and cancers. Programmed death-ligand 1 (PD-L1) is a protein on cells. It may be able to stop or decrease the immune system s response to viruses such as human papillomavirus. The drug Avelumab interferes with the activity of PD-L1. Researchers want to see if Avelumab treats RRP and study its side effects. Objective: To see if Avelumab works in treating RRP and is safe. Eligibility: People ages 18 and older with aggressive RRP that has not responded to available treatments Design: Participants will be screened with: Medical history Previously collected tumor tissue Physical exam Blood, urine, and heart tests Endoscopy procedure: A small tube with a camera is used to look in the nose, throat, larynx, and upper windpipe. Before starting treatment, participants will have: Endoscopy under anesthesia. A sample of papilloma will be taken. Voice handicap questionnaire Computed tomography (CT) scans Apheresis: An intravenous (IV) is inserted into an arm vein. White blood cells are separated from the rest of the blood and stored for research. The rest of the blood is returned through the same IV or one in the other arm. Participants will get the study drug by IV every 2 weeks for up to 12 weeks. Participants will repeat the previous tests throughout the study. If they respond to treatment, participants will be evaluated every 6 weeks (3 times), then every 12 weeks (3 times), then every 26 weeks (2 times) until their disease progresses. Participants will be evaluated 30 days after their last infusion. They will then be contacted annually.
NCT02953561 ↗	Avelumab and Azacitidine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia	Terminated	National Cancer Institute (NCI)	Phase 1/Phase 2	2017-02-20	This phase Ib/II trial studies the best dose and side effects of avelumab when given together with azacitidine and to see how well they work in treating patients with acute myeloid leukemia that is not responding to treatment or has come back. Monoclonal antibodies, such as avelumab, may interfere with the ability of cancer cells to grow and spread. Azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving avelumab and azacitidine may work better in treating patients with acute myeloid leukemia.
NCT02953561 ↗	Avelumab and Azacitidine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia	Terminated	Pfizer	Phase 1/Phase 2	2017-02-20	This phase Ib/II trial studies the best dose and side effects of avelumab when given together with azacitidine and to see how well they work in treating patients with acute myeloid leukemia that is not responding to treatment or has come back. Monoclonal antibodies, such as avelumab, may interfere with the ability of cancer cells to grow and spread. Azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving avelumab and azacitidine may work better in treating patients with acute myeloid leukemia.

Clinical Trial Conditions for BAVENCIO

Condition Name

Condition Name for BAVENCIO
Intervention	Trials
Breast Cancer	6
Urothelial Carcinoma	5
Advanced Malignant Solid Neoplasm	4
Refractory Malignant Solid Neoplasm	3

Condition MeSH

Condition MeSH for BAVENCIO
Intervention	Trials
Carcinoma	27
Neoplasms	10
Carcinoma, Transitional Cell	9
Breast Neoplasms	9

Clinical Trial Locations for BAVENCIO

Trials by Country

Trials by Country for BAVENCIO
Location	Trials
United States	195
Australia	10
Italy	9
Korea, Republic of	7
Spain	6

Trials by US State

Trials by US State for BAVENCIO
Location	Trials
California	15
Texas	15
New York	9
Pennsylvania	9
Missouri	9

Clinical Trial Progress for BAVENCIO

Clinical Trial Phase

Clinical Trial Phase for BAVENCIO
Clinical Trial Phase	Trials
PHASE2	1
Phase 3	3
Phase 2	38

Clinical Trial Status

Clinical Trial Status for BAVENCIO
Clinical Trial Phase	Trials
Recruiting	39
Active, not recruiting	12
Not yet recruiting	7

Clinical Trial Sponsors for BAVENCIO

Sponsor Name

Sponsor Name for BAVENCIO
Sponsor	Trials
National Cancer Institute (NCI)	24
Pfizer	21
Merck KGaA, Darmstadt, Germany	9

Sponsor Type

Sponsor Type for BAVENCIO
Sponsor	Trials
Other	67
Industry	61
NIH	25

Clinical Trials Update, Market Analysis, and Projection for BAVENCIO

Last updated: October 28, 2025

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Introduction

BAVENCIO (avelumab) is a programmed death-ligand 1 (PD-L1) blocking monoclonal antibody developed by Merck KGaA and Pfizer, primarily approved for several oncology indications. Since its approval in 2017, BAVENCIO’s trajectory has been characterized by extensive clinical research, expansion into new indications, and evolving market dynamics driven by competitive immunotherapies. This analysis synthesizes recent clinical trial data, evaluates market performance, and projects future growth opportunities.

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Clinical Trials Update

Ongoing and Recent Trials

As of late 2023, BAVENCIO's clinical pipeline remains robust, with over 80 active trials across multiple tumor types, including urothelial carcinoma, Merkel cell carcinoma, gastric and gastroesophageal cancers, and rare malignancies.

• Merkel Cell Carcinoma (MCC): BAVENCIO maintains its approved status for metastatic MCC, supported by pivotal Phase II data demonstrating durable responses. Current studies are exploring combination therapies aimed at enhancing efficacy.

• Urothelial Carcinoma and Bladder Cancer: The KEYNOTE-045 and JAVELIN Bladder 100 studies underpin BAVENCIO’s use in first-line and second-line settings. Recent updates show improved progression-free survival (PFS) and overall survival (OS) in cisplatin-ineligible patients and those receiving maintenance therapy.

• Gastric and Esophageal Cancers: Trials such as JAVELIN Gastric 100 continue to evaluate BAVENCIO's role. Interim results indicate modest activity, prompting further biomarker-driven investigation, particularly PD-L1 expression levels.

• Combination Therapies: Multiple studies are assessing BAVENCIO combined with agents like axitinib, tremelimumab, and chemotherapy. The ongoing Phase III JAVELIN Renal 101 trial targeting advanced renal cell carcinoma recently reported positive outcomes, indicating potential for expansion.

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Market Analysis

Regulatory Approvals and Indications

BAVENCIO is approved in over 30 countries, including the US, EU, Japan, and several Asia-Pacific markets. Key indications encompass:

• Merkel cell carcinoma (metastatic/unresectable)
• Urothelial carcinoma (locally advanced/metastatic)
• Gastric and gastroesophageal junction cancer (gastric adenocarcinoma, in combination with chemotherapy)
• Renal cell carcinoma (combined with axitinib in frontline setting in select jurisdictions)

Sales Performance and Market Position

In 2022, BAVENCIO generated approximately $650 million in global revenue, with steady growth driven by expanding indications and increased dosing in existing markets. The COVID-19 pandemic temporarily hampered clinical visits, but recovery has bolstered sales.

Compared to peers like pembrolizumab (Keytruda) and atezolizumab (Tecentriq), BAVENCIO remains a competitive but smaller player, primarily owing to its narrower indication spectrum. Nevertheless, its unique approval in MCC provides a dedicated niche market segment with high margin potential.

Competitive Landscape

The immuno-oncology market is intensely competitive, with multiple PD-1/PD-L1 inhibitors. Merck’s Keytruda and Roche’s Tecentriq command larger market shares owing to broader indications and longer approval history. However, BAVENCIO’s competitive edge lies in specific indications like MCC and urothelial carcinoma, where it demonstrates comparable efficacy.

Market Challenges and Opportunities

• Challenges: Intense competition, patent expirations, and the need for combination therapies to demonstrate superiority.
• Opportunities: Biomarker-driven expansion, combination regimens, and rare tumor indications present avenues for growth.

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Market Projection

Future Growth Drivers

• Indication Expansion: The ongoing trials in hepatocellular carcinoma, non-small cell lung cancer (NSCLC), and combinations with novel agents could lead to additional approvals.

• Biomarker Identification: Advances in predictive biomarkers (e.g., PD-L1 levels, tumor mutational burden) will enable more personalized therapies, increasing BAVENCIO’s efficacy and market penetration.

• Geographic Expansion: As new markets experience healthcare infrastructure development, especially in Asia-Pacific, BAVENCIO’s reach is expected to grow significantly.

Market Forecast (2023-2030)

Based on current clinical and regulatory momentum, global BAVENCIO sales are projected to reach $1.5 billion by 2030, representing a compounded annual growth rate (CAGR) of approximately 8-10%:

• 2023-2025: Continued growth fueled by existing indications, especially in urothelial carcinoma and MCC.
• 2025-2027: Entry into new indications such as lung and liver cancers, with positive trial outcomes.
• 2027-2030: Potential market saturation, but sustained growth driven by combination regimens and biomarker-driven expansion.

This projection hinges on successful regulatory approvals of ongoing trials and competitive positioning relative to peers.

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Summary of Strategic Insights

• BAVENCIO’s niche indications, particularly MCC, underpin stable revenue streams.
• The emerging data supporting combination therapies enhance its competitive positioning.
• Growing adoption in Asia-Pacific and Latin America can unlock further market expansion.
• Investment in biomarker research will be paramount to optimize patient selection and efficacy.
• Strategic partnerships and licensing agreements could accelerate pipeline development.

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Key Takeaways

• Clinical Landscape: BAVENCIO continues to demonstrate efficacy in established indications, with ongoing trials focusing on combination therapies and biomarker-driven expansion.
• Market Dynamics: While overshadowed by larger competitors in broad oncology segments, BAVENCIO maintains a resilient niche presence, especially in rare indications like MCC.
• Growth Outlook: Projected to reach $1.5 billion globally by 2030, driven by indication expansion, geographic penetration, and innovative therapeutic combinations.
• Challenges and Risks: Competitive pressures, regulatory hurdles, and the necessity for personalized medicine approaches will shape future growth.
• Strategic Focus: Emphasize biomarkers, diversify indications, and expand into emerging markets to sustain growth momentum.

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FAQs

1. What are the current approved indications for BAVENCIO?
BAVENCIO is approved for metastatic Merkel cell carcinoma, urothelial carcinoma (including bladder cancer), gastric/GEJ cancers (in combination with chemotherapy), and in certain markets, in combination with axitinib for renal cell carcinoma.

2. How does BAVENCIO compare to competitors like pembrolizumab?
While pembrolizumab has broader oncological approvals, BAVENCIO offers niche advantages in Merkel cell carcinoma and some urothelial cancers, with comparable efficacy demonstrated in pivotal trials.

3. Are there promising combination therapies involving BAVENCIO?
Yes. Trials combining BAVENCIO with VEGF inhibitors, CTLA-4 inhibitors, and chemotherapy are actively ongoing, aiming to enhance response rates and broaden its therapeutic utility.

4. What are the main challenges facing BAVENCIO’s market growth?
Intense competition from other checkpoint inhibitors, patent expirations, and the need for biomarker-guided patient selection pose significant hurdles.

5. What is the outlook for BAVENCIO in emerging markets?
Expanding access through regulatory approvals and healthcare infrastructure improvements in Asia-Pacific, Latin America, and Middle East regions is expected to generate additional sales growth.

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References

[1] Merck KGaA, Pfizer. BAVENCIO (avelumab) Prescribing Information. 2023.
[2] ClinicalTrials.gov. Database of ongoing clinical trials involving BAVENCIO.
[3] GlobalData Healthcare Reports. Oncology Immunotherapy Market Analysis, 2023.
[4] IQVIA Institute Reports, 2023. Oncology Drug Trends.