Recent Updates
Recently added Catalysts

Nivolumab

Phase 1

Metastatic Malignant Neoplasm in the Brain | Monoclonal antibody | Oncology |Accuray Incorporated|Last Updated: Nov 30, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02716948SRS and Nivolumab in Treating Patients With Newly Diagnosed Melanoma Metastases in the Brain or SpinePHASE1 COMPLETED 17 — — Jun 23, 2016Aug 27, 2021Nov 30, 20211 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Incidence of serious adverse events (SAE) graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 4.0
Up 12 weeks after first dose of study treatment

All SAEs will be tabulated by type and grade. Proportion of individual type of SAE event will be estimated using the binomial distribution along with 95% confidence interval (exact method).

Secondary Endpoints
Changes in the immune profile of peripheral blood during and after treatment with nivolumab in combination with stereotactic radiosurgery (immune response)
Baseline to up to 12 months
Incidence of toxicity graded according to the NCI CTC 4.0
Up to 30 days after completion of study treatment
Local control rate in brain defined as no change in number of lesions at initial treatment in the brain and change on size of targeted lesion is =< 25% from initial measurement
From date of initial nivolumab treatment to first date that progressive disease is objectively documented, assessed up to 3 years
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment (nivolumab, stereotactic radiosurgery)EXPERIMENTALPatients receive nivolumab IV over 60 minutes on day 1. Patients then undergo stereotactic radiosurgery on day 8 per standard of care. Courses with nivolumab repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Interventions
NameTypeDescription
Laboratory Biomarker AnalysisOTHERCorrelative studies
NivolumabBIOLOGICALGiven IV
Stereotactic RadiosurgeryRADIATIONUndergo stereotactic radiosurgery
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients must have histologically confirmed diagnosis of melanoma; the pathologic confirmation may be from another metastatic site or from metastatic brain or spine lesions * Patients must have stage IV melanoma, with newly identified brain or spine metastases * Patients must ...

Countries:United States
Unlock Eligibility Criteria