JAVELIN Merkel 200 is the largest trial of immunotherapy in metastatic MCC with the longest patient follow-up to date1,2

A Phase 2, open-label, single-arm, multicenter trial1

MCC Chart

*According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as measured by a blinded independent central review committee.

Assessed by independent central review committee.


  • BAVENCIO® (avelumab) was administered at 10 mg/kg IV infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity
  • Patients were premedicated with an antihistamine and acetaminophen prior to each infusion
  • Patients with radiological disease progression not associated with significant clinical deterioration could continue treatment
  • Tumor response assessments were performed every 6 weeks
  • The efficacy analysis was conducted when the last patient enrolled had completed 12 months of follow-up


Absence of significant clinical deterioration was defined as no new or worsening symptoms, no change in performance status for > 2 weeks, and no need for salvage therapy.

The JAVELIN Merkel 200 Trial included patients regardless of PD-L1 tumor expression or presence of Merkel cell polyomavirus (MCPyV)


JAVELIN Merkel 200 eligibility criteria


  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 11
  • Patients regardless of PD-L1 tumor expression or presence of Merkel cell polyomavirus (MCPyV)


  • Exclusion criteria included autoimmune disease; medical conditions requiring systemic immunosuppression; prior organ or allogeneic stem cell transplantation; prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies; central nervous system (CNS) metastases; infection with HIV, hepatitis B, or hepatitis C; or ECOG performance score ≥ 2


Patient characteristics in the 2nd-line+ cohort

Patient Characteristics

References: 1. Kaufman HL, Russell J, Hamid O, et al. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open­label, phase 2 trial. Lancet Oncol. 2016;17(10):1374-1385. 2. resultscond=merkel+cell+carcinoma&term=immune&cntryl=&state1=&recrs=#wrapper. Accessed May 3, 2021.