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NEO-PV-01

Phase 1

Urinary Bladder Cancer | Monoclonal antibody | Oncology |BioNTech SE|Last Updated: Feb 25, 2021

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 Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02897765A Personal Cancer Vaccine (NEO-PV-01) w/ Nivolumab for Patients With Melanoma, Lung Cancer or Bladder CancerPHASE1 COMPLETED 34 — — Oct 1, 2016May 1, 2020Feb 25, 20219 United States
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Study Endpoints
Primary Endpoints
Rate of adverse events including SAEs and AEs leading to treatment discontinuation
Baseline through 100 days after last dose of nivolumab
Rate of adverse events including SAEs and AEs leading to changes in safety laboratory evaluations
Baseline through 100 days after last dose of nivolumab
Rate of adverse events including SAEs and AEs leading to physical examination findings
Baseline through 100 days after last dose of nivolumab
Rate of adverse events including SAEs and AEs leading to vital signs findings
Baseline through 100 days after last dose of nivolumab
Rate of adverse events including SAEs and AEs leading to changes in ECOG status
Baseline through 100 days after last dose of nivolumab
Secondary Endpoints
Objective response rate (ORR)
Baseline through 104 weeks
Duration of response (DOR)
Baseline through 104 weeks
Clinical benefit rate (CBR)
Baseline through 104 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Drug: NEO-PV-01 + Nivolumab + AdjuvantEXPERIMENTALNivolumab at a dose of 240 mg administered by intravenous (IV) infusion over 30 minutes every two weeks. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant administered subcutaneously (one vial of pooled peptides per injection site) in up to four distinct sites (each extremity or flanks) while continuing therapy with nivolumab.
Interventions
NameTypeDescription
NEO-PV-01BIOLOGICALPersonal cancer vaccine
NivolumabBIOLOGICALmonoclonal antibody against PD1
AdjuvantOTHERimmune adjuvant
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Willing and able to give written informed consent. * Have histologically confirmed unresectable or metastatic melanoma having received no more than one prior systemic therapy for the metastatic disease (eg. ipilumamab and/or BRAF inhibitor); unresectable or metastatic smoking-...

Countries:United States
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