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Hiltonol in Advanced Solid Tumors
NCT01984892Phase 2
Key facts
- Status
- Terminated
- Start
- Nov 2013
- Primary completion
- Aug 2014
- Countries
- 1
- Sponsor
- Nina Bhardwaj
- Modality
- Antisense DNA, Small Interfering RNA (siRNA), MicroRNA (miRNA)
- Drugs
- poly iclc
- Conditions
- melanomahead and neck squamous cell carcinoma (HNSCC)cutaneous squamous cell carcinoma (cSCC)sarcomabasal cell carcinoma (BCC)
01
Overview
Phase 2, open-label, single-arm trial of poly iclc in melanoma, head and neck squamous cell carcinoma (HNSCC), cutaneous squamous cell carcinoma (cSCC) and 3 more, sponsored by Nina Bhardwaj. Primary endpoint: Progression-free Survival at 52 weeks. Started Nov 2013; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
IT and IM injections Poly-ICLC
Enrolled patients will receive two cycles of Poly-ICLC treatment. Each priming (intratumoral injections - IT) and boosting (intramuscular injections - IM) treatment course will constitute one cycle.
03
Who it enrols
Patients with histologically confirmed melanoma, squamous head and neck cancer, sarcoma, squamous cell carcinoma of the skin, basal cell skin cancer, or breast cancer who have progressed on prior therapy and have accessible tumors for injection.
04
Endpoints
Primary
Progression-free Survival
Secondary
Therapeutic Effect in Treated Patients
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