Basic Information


GTO ID GTC0092
Trial ID NCT01079741
Disease Melanoma
TherapydsRNA
Treatment Poly-ICLC
Co-treatment NY-ESO-1 protein|Montanide
PhasePhase1|Phase2
Recruitment statusCompleted
TitlePhase I/Phase II Open Label Study of the TLR3 Agonist Poly-ICLC as an Adjuvant for NY-ESO-1 Protein Vaccination With or Without Montanide ISA-51 VG in Patients With High Risk Melanoma in Complete Clinical Remission
Year2010
CountryUnited States
Company sponsorNina Bhardwaj
Other ID(s)GCO 13-1391

Clinical Result

Cohort1: Poly-ICLC_dose level 1_NY-ESO-1_Montanide
Administration route subcutaneous injection
Dosage 0.35 mg
Pts 3
Age Adult, Older_Adult
Outcome Phase I, Number of Participants With SAE and DLT:Serious Adverse Events:0(0.0%); DLT:0(0.0%)
Adverse reactions No serious clinical adverse events
Cohort2: Poly-ICLC_dose level 2_NY-ESO-1_Montanide
Administration route subcutaneous injection
Dosage 0.7 mg
Pts 4
Age Adult, Older_Adult
Outcome Phase I, Number of Participants With SAE and DLT:Serious Adverse Events:0(0.0%); DLT:0(0.0%)
Adverse reactions No serious clinical adverse events
Cohort3: Poly-ICLC_dose level 3_NY-ESO-1_Montanide(Dose-escalation component)
Administration route subcutaneous injection
Dosage 1.4mg
Pts 3
Age Adult, Older_Adult
Outcome Phase I, Number of Participants With SAE and DLT:Serious Adverse Events:1(33.3%); DLT:0(0.0%)
Adverse reactions 1/3(Cardiac disorders)

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