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Resiquimod

Phase 1

Advanced Malignancies | Monoclonal antibody | Other |Celldex Therapeutics, Inc.|Last Updated: Jun 27, 2016

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
UNCONTROLLED
Total Trials1
Total Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00948961A Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1PHASE1 COMPLETED 70Sep 1, 2009Feb 1, 2014Jun 27, 20167 United States
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Study Endpoints
Primary Endpoints
Occurrence of adverse events (side effects)
12 weeks (1 cycle of study treatment)
Secondary Endpoints
Objective response rate (CR/PR), disease control rate (CR/PR/SD) and time to progression, based on disease-appropriate response criteria.
12 week intervals
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
CDX-1401 in combination with Resiquimod and/or Poly-ICLCBIOLOGICALCDX-1401 is administered as an injection into the skin every 2 weeks for 4 doses. It is given in combination with Resiquimod and/or poly-ICLC. Resiquimod is administered as a topical gel applied to the skin or given as an injection under the skin, and poly-ICLC is given as an injection under the skin. Depending on the treatment group assignment, either one or both of the immune stimulants will be given on the day of and the day after CDX-1401 administrations. This treatment may be repeated every 12 weeks.
CDX-1401BIOLOGICAL -
ResiquimodBIOLOGICAL -
poly-ICLCBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: Among other criteria, patients must meet all of the following conditions to be eligible to be in the study: 1. 18 years of age or older. 2. Have a cancer type that is known to express NY-ESO-1, including (but not limited to) cancer of the bladder, breast, ovary, non-small cell ...

Countries:United States
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