Avelumab

PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production.

• BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody indicated for: Merkel Cell Carcinoma (MCC) Adults and pediatric patients 12 years and older with metastatic MCC. ( 1.1 , 14.1 ) Urothelial Carcinoma (UC) Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy.

• None. None.contraindicated

Premedicate for the first 4 infusions and subsequently as needed. ( 2.1 ) Merkel Cell Carcinoma : 800 mg every 2 weeks. ( 2.2 ) Urothelial Carcinoma ; 800 mg every 2 weeks. ( 2.3 ) Renal Cell Carcinoma : 800 mg every 2 weeks in combination with axitinib 5 mg orally twice daily. ( 2.4 ) Administer BAVENCIO as an intravenous infusion over 60 minutes. 2.1 Premedication Premedicate patients with an antihistamine and with acetaminophen prior to the first 4 infusions of BAVENCIO. Premedication should be administered for subsequent BAVENCIO doses based upon clinical judgment and presence/severity of prior infusion reactions [see Dosage and Administration (2.5) and Warnings and Precautions (5.2) ]. 2.2 Recommended Dosage for MCC The recommended dosage of BAVENCIO is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. 2.3 Recommended Dosage for UC The recommended dosage of BAVENCIO is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. 2.4 Recommended Dosage for RCC The recommended dosage of BAVENCIO is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks in combination with axitinib 5 mg orally taken twice daily (12 hours apart) with or without food until disease progression or unacceptable toxicity. When axitinib is used in combination with BAVENCIO, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of two weeks or longer.

Immune-Mediated Adverse Reactions ( 5.1 ) Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions, and may result in solid organ transplant rejection. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue based on severity and type of reaction. Infusion-related reactions : Interrupt, slow the rate of infusion, or permanently discontinue BAVENCIO based on severity of reaction. ( 5.2 ) Complications of allogeneic HSCT : Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody. ( 5.3 ) Major adverse cardiovascular events : Optimize management of cardiovascular risk factors. Discontinue BAVENCIO in combination with axitinib for Grade 3-4 events. ( 5.4 ) Embryo-fetal toxicity : BAVENCIO can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception.

The following clinically significant adverse reactions are described elsewhere in the labeling: Severe and fatal immune-mediated adverse reactions [see Warnings and Precautions (5.1) ] Infusion-related reactions [see Warnings and Precautions (5.2) ] Complications of allogeneic HSCT [see Warnings and Precautions (5.3) ] Major adverse cardiovascular events [see Warnings and Precautions (5.4) ] Most common adverse reactions (≥ 20%) in patients were: MCC : Fatigue, musculoskeletal pain, infusion-related reaction, rash, nausea, constipation, cough, and diarrhea. ( 6.1 ) UC : Maintenance treatment: fatigue, musculoskeletal pain, urinary tract infection, and rash. ( 6.1 ) Previously-treated: fatigue, infusion-related reaction, musculoskeletal pain, nausea, decreased appetite, and urinary tract infection. ( 6.1 ) RCC (with axitinib) : diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at 1-800-283-8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action, BAVENCIO can cause fetal harm when administered to a pregnant woman. There are no available data on the use of BAVENCIO in pregnant women [see Clinical Pharmacology (12.1) ] . Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death [see Data ] . Human IgG1 immunoglobulins (IgG1) are known to cross the placenta. Therefore, BAVENCIO has the potential to be transmitted from the mother to the developing fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with BAVENCIO to evaluate its effect on reproduction and fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus.

Metabolism

The pharmacokinetics (PK) of avelumab as a single agent was characterized in patients who received BAVENCIO at doses ranging from 1 to 20 mg/kg every 2 weeks (0.1 to 2 times of the approved recommended dosage). The exposure of avelumab increased dose-proportionally from 10 to 20 mg/kg every 2 weeks.

• Mar 23, 2017BLABLA761049Emd Serono Inc

1. 1Disease Progression3719.4%
2. 2Death3709.4%
3. 3Off Label Use2265.7%
4. 4Diarrhoea1674.2%
5. 5Pyrexia1473.7%
6. 6Infusion Related Reaction1453.7%
7. 7Fatigue1313.3%
8. 8Neoplasm Progression1253.2%
9. 9Nausea1082.7%
10. 10Dyspnoea1052.7%
11. 11Hypertension1022.6%
12. 12Interstitial Lung Disease1022.6%
13. 13Chills1012.6%
14. 14Rash992.5%
15. 15Acute Kidney Injury872.2%

The 10 most recently updated of 299 ClinicalTrials.gov registrations naming Avelumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study
  Active not recruiting · Phase 3 · Interventional · 654 enrolled · National Cancer Institute (NCI)
  NCT05092958updated 2026-06-12
• Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy
  Recruiting · Phase 1 · Phase 2 · Interventional · 90 enrolled · National Cancer Institute (NCI)
  NCT04071236updated 2026-06-11
• Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 103 enrolled · National Cancer Institute (NCI)
  NCT04068194updated 2026-06-11
• Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 23 enrolled · M.D. Anderson Cancer Center
  NCT04266912updated 2026-06-11
• Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)
  Recruiting · Phase 2 · Interventional · 45 enrolled · National Cancer Institute (NCI)
  NCT06228066updated 2026-06-05
• Avelumab With or Without Cetuximab in Treating Patients With Advanced Skin Squamous Cell Cancer
  Active not recruiting · Phase 2 · Interventional · 60 enrolled · Alliance for Clinical Trials in Oncology
  NCT03944941updated 2026-06-02
• A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
  Active not recruiting · Phase 2 · Interventional · 56 enrolled · National Cancer Institute (NCI)
  NCT03076554updated 2026-05-29
• Study of Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320)
  Active not recruiting · Phase 1 · Interventional · 120 enrolled · EMD Serono Research & Development Institute, Inc.
  NCT05396833updated 2026-05-28
• JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study
  Active not recruiting · Observational · 360 enrolled · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
  NCT06412848updated 2026-05-28
• Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
  Active not recruiting · Phase 2 · Interventional · 375 enrolled · BicycleTx Limited
  NCT06225596updated 2026-05-27

Frequently asked questions

How does Avelumab work?

PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production.

What is Avelumab used for?

According to FDA labeling, Avelumab carries indications including: BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody indicated for: Merkel Cell Carcinoma (MCC) Adults and pediatric patients 12 years and older with metastatic MCC. ( 1.1 , 14.1 ) Urothelial Carcinoma (UC) Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Avelumab?

Avelumab is classified as PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors, Programmed Death Ligand-1 Blocker, Programmed Death Ligand-1 Antagonists, Programmed Death Ligand-1-directed Antibody Interactions, Increased Immunologic Activity.

What are the brand names for Avelumab?

Avelumab is marketed under brand names including Bavencio.

What are the contraindications for Avelumab?

Avelumab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.