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Autologous dendritic cells

Phase 2

Follicular Lymphoma | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Mar 1, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02677155Sequential Intranodal Immunotherapy (SIIT) Combined With Anti-PD1 (Pembrolizumab) in Follicular LymphomaPHASE2 COMPLETED 10 — — Jan 1, 2016Feb 1, 2021Mar 1, 20211 Norway
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Study Endpoints
Primary Endpoints
Overall response rate
Evaluated at baseline, 2, 4, 8, 12 and 24 months

Change in tumor load from baseline until maximal regression

Secondary Endpoints
Duration of response
From date of documented response until progression, assessed up to 60 months
Progression-free survival
From date of inclusion until date of documented progression or death of any cause, whichever came first, assessed up to 60 months
Time to next treatment
From date of inclusion until start of next treatment, assessed up to 60 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Intranodal immunotherapy and anti-PD1EXPERIMENTALInduction phase: 3 cycles of sequential intranodal immunotherapy (SIIT), every second week: Radiotherapy 8 Gy single dose day 2, Rituximab 5 mg intranodal day 1 and 3, Autologous dendritic cells 1x 10 e8 intranodal day 4 and 5, GM-CSF 50 ug subcutaneously day 4 and 5, Pembrolizumab 200 mg intravenous day 5, Consolidation phase: Pembrolizumab 200 mg intravenous every third week for 8 cycles
Interventions
NameTypeDescription
RadiotherapyRADIATIONRadiotherapy 8 Gy single dose
RituximabBIOLOGICALIntranodal injection 5 mg
Autologous dendritic cellsBIOLOGICALIntranodal injection of 1 x 10 e8 cells
GM-CSFBIOLOGICALSubcutaneous injection of 50 ug
PembrolizumabBIOLOGICALIntravenous infusion of 200 mg
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Be willing and able to provide written informed consent/assent for the trial. 2. Be \>= 18 years of age on day of signing informed consent. 3. Histologically confirmed incurable asymptomatic untreated or relapsed follicular lymphoma grade I-IIIA stage III-IV 4. Lymphoma nodes...

Countries:Norway
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