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Avelumab

Phase 2

Cancer That is Associated With a Chronic Viral Infection | Monoclonal antibody | Other |Avalon GloboCare Corp.|Last Updated: Jun 26, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

Avelumab · 1 trial · 8 indications

Phase 2 1
NCT03357757Avelumab With Valproic Acid in Virus-associated CancerCancer That is Associated With a Chronic Viral Infection
COMPLETED39 Analytics
PHASE2COMPLETED
Avelumab With Valproic Acid in Virus-associated Cancer
Cancer That is Associated With a Chronic Viral Infection
NCT0335775739
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Study Endpoints

Primary Endpoints

Efficacy of Avelumab and VPA
1 year after enrolment of last patient

• Assessment of the clinical response rate according to the immune-related RECIST criteria (iRECIST)

Proportion of subjects who complete 4 doses of Avelumab in combination with VPA
1 year after enrolment of last patient

• Feasibility analysis, defined as the proportion of subjects who complete 4 doses of Avelumab in combination with VPA over the total duration of the study.

Secondary Endpoints

Overall survival
5 years from final study drug dose
Progression free survival
5 years from final study drug dose
Number of participants with adverse events
Through study completion, up to 2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Avelumab with VPAEXPERIMENTALValproic Acid (VPA, 12.5 mg/kg) once per day and Avelumab (10 mg/kg IV) every 2 weeks for up to 2 years.

Interventions

NameTypeDescription
Valproic AcidDRUGThe target serum level for VPA will be between 75 and 100 mcg/mL checked every 2 weeks for the first 6 cycles.
AvelumabBIOLOGICAL10 mg/kg IV
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients must be 18 years of age or older. * Patients with the following histologically confirmed diagnoses will be eligible for enrolment: p16 positive SCCHN; squamous cell carcinoma of the cervix; p16 positive squamous cell carcinoma of the vagina or vulva; p16 positive squa...

Countries:Canada
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