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Avelumab

Phase 3

Solid Tumors | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Mar 31, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment205
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03815643Avelumab Program Rollover StudyPHASE3 ACTIVE NOT_RECRUITING 205 — — Mar 22, 2019Aug 21, 2026Mar 31, 2026104 United States, Argentina +20
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Study Endpoints
Primary Endpoints
Occurrence of Treatment-related Non-serious Treatment-Emergent Adverse Events (TEAEs), All Serious AEs, Immunerelated AEs and Infusion-related Reactions According to Version of National Cancer Institute Common Technology Criteria for Adverse Events
From enrollment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab)
Secondary Endpoints
Overall Survival (OS)
From baseline up to 5 years
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
From baseline up to 5 years
Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR)
From baseline up to 5 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AvelumabEXPERIMENTAL -
Interventions
NameTypeDescription
AvelumabDRUGParticipants entering this roll over study will receive avelumab as a 1-hour intravenous (IV) infusion at 10 milligram per kilogram (mg/kg) once every 2 weeks until progressive disease, according to respective parent studies (EMR100070-001, EMR100070-002, EMR100070-004 and EMR100070-008).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites104

Inclusion Criteria: * Participants under enrollment and treatment in an avelumab clinical study under the sponsorship of EMD Serono Research \& Development Institute, Inc. / Merck KGaA, Darmstadt, Germany * Merck Serono Co., Ltd (Japan) * Participants currently enrolled in an avelumab parent stu...

Countries:United StatesArgentinaAustraliaBelgiumBrazilBulgariaCzechiaFranceGermanyHungaryItalyJapanMexicoPolandRomaniaRussiaSouth KoreaSpainThailandTurkey (Türkiye)UkraineUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT03815643studyFirstPostDate: changed