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Onivyde

Phase 1

Recurrent Solid Tumor | Small molecule | Oncology |Pfizer, Inc.|Last Updated: May 19, 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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04901702Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing SarcomaPHASE1 RECRUITING 90 — — Jun 9, 2021Dec 31, 2026May 19, 202610 United States, Canada
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Study Endpoints
Primary Endpoints
Phase I:To determine the recommended phase 2 doses (RP2Ds) of Onivyde combined with talazoparib (Arm A) and Onivyde combined with temozolomide (Arm B) administered to children, adolescents and young adults with refractory or recurrent solid malignancies.
approximately 21 days

First cycle dose limiting toxicity (DLTs) will be used to determine the RP2Ds of the two treatment arms. The DLT is defined as any of the following events that are possibly, probably or definitely attributable to protocol therapy.

Phase II:To estimate the progression-free survival (PFS) of Onivyde plus talazoparib and Onivyde plus temozolomide in patients with refractory or recurrent Ewing sarcoma.
for five years following the date the last patient was randomized

The study is designed to compare the progression-free survival (PFS) of Onivyde plus talazoparib and Onivyde plus temozolomide in patients with refractory or recurrent Ewing sarcoma. PFS is defined as the time from randomization to disease progression or death, whichever is earlier.

Secondary Endpoints
Phase I:To characterize the safety profile of the treatment regimens, Onivyde plus talazoparib (Arm A) and Onivyde plus temozolomide (Arm B)
At the end of treatment (up to 24 months after enrollment of last participant)]
To characterize the plasma pharmacokinetics of Onivyde plus talazoparib (Arm A) and Onivyde plus temozolomide (Arm B)
At the end of Cycle 1 (each cycle is 21 days)
To estimate the antitumor activity of Onivyde plus talazoparib (Arm A) and Onivyde plus temozolomide (Arm B)
At time of randomization until evaluation of respective endpoints, up to 4 months after enrollment of last participant
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
(Arm A) ONI plus TALACTIVE_COMPARATORThe phase I/II study will evaluate a treatment regimen; nanoliposomal irinotecan (nal-IRN, Onivyde) plus talazoparib (TAL)
(Arm B) ONI plus TMZACTIVE_COMPARATORThe phase I/II study will evaluate a treatment regimen; Onivyde (ONI) plus temozolomide (TMZ)
Interventions
NameTypeDescription
OnivydeDRUGGiven intravenous on Days 1 and 8
TalazoparibDRUGGiven orally twice on Day 1 (daily maximum is 1000mcg/day), then daily on Days 2-6
TemozolomideDRUGGiven once a day on Days 1-5.
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Eligibility Criteria
Age Range12 Months — 30 Years
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria Patients must be \> 12 months and \< 30 years at the time of enrollment on study. Phase I * Patients with refractory or recurrent non-central nervous system (CNS) solid tumors not amenable to curative treatment are eligible. Patients must have had histologic verification of mal...

Countries:United StatesCanada
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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, 2026NCT04901702studyFirstPostDate: changed