NCT02521870

A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Dynavax Technologies Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 head and neck squamous cell carcinoma (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 a recommended Phase 2 dose (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).

Conditions

• Metastatic Melanoma
• Head Neck Cancer

Interventions

Type	Name	Description
DRUG	SD-101(1)	SD-101 administered intratumorally at escalating doses (up to 11 doses).
BIOLOGICAL	Pembrolizumab	Pembrolizumab administered intravenously, 200 mg Q3W for two years (up to 35 doses).
DRUG	SD-101(2)	Dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses).
BIOLOGICAL	Pembrolizumab	Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses).
BIOLOGICAL	SD-101(3)	Dose Q1W for 4 weeks followed by dose Q3W for 16 additional weeks (up to 20 total doses).
BIOLOGICAL	Pembrolizumab	Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses).

Timeline

• Start date: 2015-09-01
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2015-08-13
• Last updated: 2021-08-03
• Results posted: 2021-08-03

Locations

47 sites across 4 countries: United States, Australia, Germany, New Zealand