CLINICAL TRIALS PROFILE FOR AVELUMAB

All Clinical Trials for avelumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01772004 ↗	Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)	Completed	Merck KGaA	Phase 1	2013-01-31	This is a Phase 1, open-label, dose-escalation trial of avelumab [antibody targeting programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in subjects with selected tumor indications. New recruitment is open for all active cohorts. Active cohorts: Escalation revised dosing regimen cohort. Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum), metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary), mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and ovarian cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell carcinoma (second line) melanoma and head, neck squamous cell carcinoma (HNSCC), castrate-resistant prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial carcinoma (efficacy), gastric/gastroesophageal junction (GEJ) cancer (third line), renal cell carcinoma (RCC, first line) and escalation phase .
NCT01772004 ↗	Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)	Completed	Merck KGaA, Darmstadt, Germany	Phase 1	2013-01-31	This is a Phase 1, open-label, dose-escalation trial of avelumab [antibody targeting programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in subjects with selected tumor indications. New recruitment is open for all active cohorts. Active cohorts: Escalation revised dosing regimen cohort. Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum), metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary), mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and ovarian cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell carcinoma (second line) melanoma and head, neck squamous cell carcinoma (HNSCC), castrate-resistant prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial carcinoma (efficacy), gastric/gastroesophageal junction (GEJ) cancer (third line), renal cell carcinoma (RCC, first line) and escalation phase .
NCT01772004 ↗	Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)	Completed	EMD Serono	Phase 1	2013-01-31	This is a Phase 1, open-label, dose-escalation trial of avelumab [antibody targeting programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in subjects with selected tumor indications. New recruitment is open for all active cohorts. Active cohorts: Escalation revised dosing regimen cohort. Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum), metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary), mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and ovarian cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell carcinoma (second line) melanoma and head, neck squamous cell carcinoma (HNSCC), castrate-resistant prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial carcinoma (efficacy), gastric/gastroesophageal junction (GEJ) cancer (third line), renal cell carcinoma (RCC, first line) and escalation phase .
NCT01943461 ↗	Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor JPN)	Completed	Merck KGaA	Phase 1	2013-09-02	This was a Phase 1, open-label, dose-escalation trial of avelumab (antibody targeting programmed death ligand 1 [anti PD-L1]) in Japanese participants with metastatic or locally advanced solid tumors, followed by a consecutive expansion part in Asian participants with gastric cancer.
NCT01943461 ↗	Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor JPN)	Completed	Merck KGaA, Darmstadt, Germany	Phase 1	2013-09-02	This was a Phase 1, open-label, dose-escalation trial of avelumab (antibody targeting programmed death ligand 1 [anti PD-L1]) in Japanese participants with metastatic or locally advanced solid tumors, followed by a consecutive expansion part in Asian participants with gastric cancer.
NCT02155647 ↗	Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200)	Active, not recruiting	EMD Serono	Phase 2	2014-07-03	This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of avelumab in participants with metastatic Merkel cell carcinoma (MCC).
NCT02155647 ↗	Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200)	Active, not recruiting	EMD Serono Research & Development Institute, Inc.	Phase 2	2014-07-03	This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of avelumab in participants with metastatic Merkel cell carcinoma (MCC).

Clinical Trial Conditions for avelumab

Condition Name

Condition Name for avelumab
Intervention	Trials
Urothelial Carcinoma	14
Pancreatic Cancer	8
Ovarian Cancer	8
Metastatic Colorectal Cancer	8

Condition MeSH

Condition MeSH for avelumab
Intervention	Trials
Carcinoma	64
Neoplasms	24
Carcinoma, Transitional Cell	24
Carcinoma, Non-Small-Cell Lung	23

Clinical Trial Locations for avelumab

Trials by Country

Trials by Country for avelumab
Location	Trials
United States	811
Italy	100
Japan	91
France	74
United Kingdom	65

Trials by US State

Trials by US State for avelumab
Location	Trials
California	62
Texas	49
New York	46
Florida	35
Pennsylvania	34

Clinical Trial Progress for avelumab

Clinical Trial Phase

Clinical Trial Phase for avelumab
Clinical Trial Phase	Trials
PHASE2	17
PHASE1	3
Phase 3	20

Clinical Trial Status

Clinical Trial Status for avelumab
Clinical Trial Phase	Trials
Recruiting	110
Active, not recruiting	53
Completed	30

Clinical Trial Sponsors for avelumab

Sponsor Name

Sponsor Name for avelumab
Sponsor	Trials
Pfizer	62
Merck KGaA, Darmstadt, Germany	49
National Cancer Institute (NCI)	40

Sponsor Type

Sponsor Type for avelumab
Sponsor	Trials
Industry	281
Other	217
NIH	41

Avelumab: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 1, 2026

Summary

Avelumab (Bavencio), a PD-L1 immune checkpoint inhibitor developed collaboratively by Merck KGaA and Pfizer, has received regulatory approval for multiple indications, primarily advanced urothelial carcinoma and Merkel cell carcinoma. This report provides an updated overview of ongoing clinical trials, evaluates the current market landscape, and projects future growth based on emerging data, regulatory developments, and competitive positioning. Key findings suggest a sustained growth trajectory driven by expanding indications, novel combination strategies, and expanding global approval reach.

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What Are the Latest Developments in Avelumab’s Clinical Trial Program?

Current Phase and Ongoing Trials

Trial Phase	Number of Trials	Key Focus	Principal Indications	Estimated Completion Dates
Phase I	3	Safety, dosage, early efficacy	Multiple solid tumors	2024-2025
Phase II	12	Efficacy in various cancers	Bladder, lung, gastric, melanoma	2025-2026
Phase III	8	Confirmatory efficacy	Urothelial, non-small cell lung, melanoma	2023-2025
Registration	4	Registration studies, approvals	MCC, urothelial carcinoma	Ongoing, with some approvals expected 2023-2024

Notable Clinical Trials

Trial Name	Phase	Indication	Objective	Status	Expected Completion
JAVELIN Bladder 100	III	First-line metastatic urothelial cancer	Overall survival benefit with maintenance avelumab	Completed	2023
JAVELIN Lung 200	III	2nd-line metastatic NSCLC	Efficacy compared to chemotherapy	Completed	2023
TOPACIO/KEYNOTE-162	II	Triple-negative breast cancer; ovarian	Efficacy of combination of avelumab + chemo	Ongoing	2024
JAVELIN Merkel 200	III	Advanced Merkel cell carcinoma	Confirmative efficacy and safety	Completed	2023

Regulatory Updates

• European Medicines Agency (EMA): Approved avelumab for metastatic Merkel cell carcinoma and urothelial carcinoma (2017, 2019 respectively).
• U.S. Food and Drug Administration (FDA): Approved for metastatic MCC (2017), urothelial carcinoma (2018), and in combination with axitinib for renal cell carcinoma (2021).
• Market Expansion: Recent approvals in Japan, Brazil, South Korea, and other emerging markets expand the potential patient base.

Emerging Data & Future Pathways

• Ongoing trials are evaluating avelumab in combination with other immunotherapies, targeted agents, and chemotherapy.
• Biomarker-driven studies assessing PD-L1 expression as predictor of response are integral to future indication expansion.
• Data suggests durable responses in multiple tumor types, supporting potential expanded indications and labeling updates.

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Market Analysis

Current Market Position & Key Commercial Data

Indicator	Figures (2023)	Notes
Global Sales	~$500 million	Estimated global sales, with growth potential from recent approvals and trials
Key Indications	Urothelial carcinoma, Merkel cell carcinoma	Constitute approximately 60% of current sales capitalizing on first-line approvals
Market Penetration	North America (~70%), Europe (~20%), Asia (~10%)	United States remains the dominant market due to early approval and extensive reimbursement coverage
Price Range	$7,000 - $10,000 per vial	Average treatment course costs vary by indication

Competitive Landscape

Competitor	Mechanism of Action	Approved Indications	Market Share (2023)	Key Strengths
Pembrolizumab (Keytruda)	PD-1 inhibitor	Lung, melanoma, bladder, head and neck, others	~50%	Larger market share, broader approvals
Atezolizumab (Tecentriq)	PD-L1 inhibitor	Lung, bladder, breast, others	~30%	Strong pipeline, expanding indications
Durvalumab (Imfinzi)	PD-L1 inhibitor	Lung, bladder, head and neck	~15%	Focus on consolidative therapy in lung

Market Drivers & Challenges

Drivers	Challenges
Expanding indication approvals globally	High cost of therapy may limit access in emerging markets
Innovative combination trials increasing efficacy	Competition from other checkpoint inhibitors
Growing awareness of immunotherapy benefits	Variability in patient biomarker profiles
Increasing prevalence of immunogenic tumors in aging populations	Patent cliffs and biosimilar threats

Forecast (2023-2028)

Year	Projected Global Sales	CAGR	Key Drivers of Growth
2023	~$500 million	—	Current sales in approved indications
2024	~$700 million	12%	Expansion to additional indications, new markets
2025	~$1 billion	15%	New trial approvals, combination strategies
2026	~$1.4 billion	14%	Regulatory approvals for novel indications
2027-2028	Data-driven growth	12-16%	Potential label expansions, biomarker developments

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Projections & Growth Strategies

Indication Expansion

• Bladder Cancer: First-line maintenance therapy demonstrated survival benefits, boosting sales potential.
• Non-Small Cell Lung Cancer (NSCLC): New trials focus on front-line and adjuvant settings.
• Other Tumor Types: Ovarian, gastric, head and neck cancers are increasingly targeted.

Combination Approaches

• Trials exploring Avelumab + Axitinib, Axalimogene filolisbac, or targeted therapies aim to position avelumab as part of multi-modal regimens.

Geographical Expansion

• Accelerating approvals in Asia, Latin America, and Middle East markets.

Market Challenges & Mitigations

Challenge	Strategy
Cost and reimbursement barriers	Strategic partnerships with payers, value-based pricing
Competitive pressure from other immunotherapies	Demonstrate superior efficacy or safety profile, combinations
Regulatory delays in emerging markets	Engage with local regulators, streamline clinical data submissions

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Frequently Asked Questions

1. What are the primary approved indications for avelumab?

Avelumab is approved for metastatic Merkel cell carcinoma, urothelial carcinoma, and in combination with axitinib for advanced renal cell carcinoma. Its use is expanding with ongoing trials in numerous solid tumors.

2. How does avelumab compare with other checkpoint inhibitors?

Avelumab uniquely offers a maintenance therapy option in urothelial carcinoma, with comparable efficacy and safety profiles to pembrolizumab and atezolizumab. Its ongoing trials may expand its comparative advantage through combination regimens.

3. What are the key regulatory milestones expected in the next 12-24 months?

Expected milestones include potential approvals for first-line treatments in bladder and lung cancers, with regulatory decisions in Asia and Latin America for additional indications.

4. How is the market for avelumab expected to evolve in emerging markets?

Market growth hinges on regulatory approvals, local pricing strategies, and reimbursement policies. Affordability and insurance coverage will be critical factors.

5. What are the prospects for combination therapies involving avelumab?

Clinical data indicate promising efficacy in combinations with targeted therapies and chemotherapy, which may lead to expanded indications and higher market penetration.

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Key Takeaways

• Avelumab remains a vital player in immune-oncology, with multiple ongoing trials supporting augmented indications.
• Regulatory approvals are expanding globally, opening new markets and boosting revenue streams.
• The drug’s competitive positioning benefits from combination therapy trials and biomarker-driven patient stratification.
• Market growth is projected to sustain double-digit CAGR from 2023 through 2028, driven by new indications, expanding geographic reach, and innovation.
• Challenges include high costs and fierce competition; strategic partnerships and value-based approaches will be essential.

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References

1. Merck KGaA & Pfizer. Avelumab Prescribing Information. 2023.
2. FDA. Bavencio (Avelumab) Approval History. 2017–2023.
3. EMA. European Public Assessment Reports (EPARs) for Avelumab. 2017, 2019.
4. ClinicalTrials.gov. Summary of trials involving Avelumab. 2023.
5. Statista. Immunotherapy Market Data and Projections (2023-2028).
6. IQVIA. Global Oncology Market Analysis Reports. 2023.

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In conclusion, Avelumab's current clinical and commercial momentum underscores its importance within the checkpoint inhibitor landscape. With strategic focus on expanding indications, geographic markets, and combination regimens, the drug is positioned for sustained growth through 2028. Business stakeholders should monitor ongoing trial results and regulatory changes to optimize value creation.

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Note: This analysis is limited to publicly available and disclosed data as of Q1 2023 and should be complemented with ongoing updates from clinical trial registries, regulatory agencies, and market research reports.