Trial ID or NCT#

NCT02521870

Status

NOT RECRUITING

Purpose

This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD-101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic HNSCC. This study will be conducted in 2 phases. Phase 1 evaluates SD-101 given in combination with pembrolizumab in melanoma populations (anti-PD-1/L1 naïve and anti-PD-1/L1 experienced with progressive disease) in up to 4 Dose Escalation cohorts to identify an RP2D to be evaluated in up to 4 Dose Expansion cohorts in Phase 2. Phase 2 also includes up to 4 Dose Expansion cohorts of patients with HNSCC (anti-PD-1/L1 naïve and anti-PD-1/L1 experienced with progressive disease). The following schema presents the study design for melanoma Phase 1 and Phase 2 and for HNSCC Phase 2.

Official Title

A Phase 1b/2, Open-label, Multicenter, Dose-escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (SYNERGY-001)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Susan M. Swetter, MD
Dermatologist, Dermatologic oncologist, Cutaneous oncology specialist, Melanoma specialist
Professor of Dermatology at Palo Alto Veterans Affairs Health Care System and the Stanford University Medical Center
Bernice Kwong, MD
Dermatologist, Dermatologic oncologist, Cutaneous oncology specialist, Dermato-oncology specialist, Dermatopathologist
Clinical Associate Professor, Dermatology
Shivaani Kummar
Medical oncologist, Sarcoma specialist
Professor of Medicine (Oncology) and of Radiology (Molecular Imaging Program at Stanford) at the Stanford University Medical Center

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CONTACT

CCTO
(650) 498-7061