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
- Conditions
- Metastatic MelanomaHead Neck Cancer
- Interventions
- Drug: SD-101(1)Drug: SD-101(2)Biological: SD-101(3)Biological: Pembrolizumab
- Registration Number
- NCT02521870
- Lead Sponsor
- Dynavax Technologies Corporation
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 241
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose Escalation Phase 1b SD-101(1) Determine the maximum tolerated dose (MTD) of escalating doses of SD-101(1) administered in combination with pembrolizumab in patients with melanoma (anti-PD-1/L1 therapy naïve and experienced patients with progressive disease). Dose Escalation Phase 1b Pembrolizumab Determine the maximum tolerated dose (MTD) of escalating doses of SD-101(1) administered in combination with pembrolizumab in patients with melanoma (anti-PD-1/L1 therapy naïve and experienced patients with progressive disease). Dose Expansion Phase 2 (Cohort 1) SD-101(2) Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent or metastatic melanoma. Dose Expansion Phase 2 (Cohort 1) Pembrolizumab Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent or metastatic melanoma. Dose Expansion Phase 2 (Cohort 2) SD-101(2) Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy progressing patients with recurrent or metastatic melanoma. Dose Expansion Phase 2 (Cohort 2) Pembrolizumab Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy progressing patients with recurrent or metastatic melanoma. Dose Expansion Phase 2 (Cohort 3) SD-101(2) Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent head and neck squamous cell carcinoma. Dose Expansion Phase 2 (Cohort 3) Pembrolizumab Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent head and neck squamous cell carcinoma. Dose Expansion Phase 2 (Cohort 4) SD-101(2) Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy progressing patients with recurrent head and neck squamous cell carcinoma. Dose Expansion Phase 2 (Cohort 4) Pembrolizumab Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy progressing patients with recurrent head and neck squamous cell carcinoma. Dose Expansion Phase 2 (Cohort 5) SD-101(3) Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent or metastatic melanoma. Dose Expansion Phase 2 (Cohort 5) Pembrolizumab Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent or metastatic melanoma. Dose Expansion Phase 2 (Cohort 6) SD-101(3) Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent head and neck squamous cell carcinoma. Dose Expansion Phase 2 (Cohort 6) Pembrolizumab Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent head and neck squamous cell carcinoma. Dose Expansion Phase 2 (Cohort 7) SD-101(3) Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy refractory or resistant patients with recurrent head and neck squamous cell carcinoma. Dose Expansion Phase 2 (Cohort 7) Pembrolizumab Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy refractory or resistant patients with recurrent head and neck squamous cell carcinoma. Dose Expansion Phase 2 (Cohort 8) SD-101(3) Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy refractory or resistant patients with recurrent or metastatic melanoma. Dose Expansion Phase 2 (Cohort 8) Pembrolizumab Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy refractory or resistant patients with recurrent or metastatic melanoma.
- Primary Outcome Measures
Name Time Method Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group Day 1 through Day 743 Overall response rate (ORR) by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Phase 1 Dose Escalation Only - Number of Participants With DLTs Day 1 through Day 29 Dose-limiting toxicities (DLTs) are defined per protocol as specific AEs occurring from the time of the first injection (Day 1) through Day 29.
- Secondary Outcome Measures
Name Time Method Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group Day 1 through Day 743 Progression-Free Survival (PFS) rate by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Time to Objective Response by Analysis Group Day 1 through Day 743 Time to objective response by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Duration of Response by Analysis Group Day 1 through Day 743 Duration of response by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Disease Control Rate (DCR) by Analysis Group Day 1 through Day 743 Disease Control Rate (DCR) by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Trial Locations
- Locations (47)
Inova Schar Cancer Institute
🇺🇸Fairfax, Virginia, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Georgia Cancer Center - Northside Hospital Central Research Department
🇺🇸Atlanta, Georgia, United States
University of California, San Diego
🇺🇸San Diego, California, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Hollywood Private Hospital / Affinity Research
🇦🇺Nedlands, Western Australia, Australia
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Stanford Hospitals and Clinics
🇺🇸Palo Alto, California, United States
University of Iowa Healthcare
🇺🇸Iowa City, Iowa, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Adelaide Cancer Centre - Ashford Cancer Centre
🇦🇺Kurralta Park, South Australia, Australia
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Atlantic Health
🇺🇸Morristown, New Jersey, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Melanoma Institute
🇦🇺Wollstonecraft, New South Wales, Australia
HNO-Universitätsklinik Jena
🇩🇪Jena, Germany
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Klinikum BuxtehudeDermato-Onkologie Studienzentrale
🇩🇪Buxtehude, Germany
Auckland City Hospital
🇳🇿Auckland, New Zealand
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinikum Tübingen
🇩🇪Tubingen, Germany
Waikato Hospital
🇳🇿Hamilton, New Zealand
Uniklinikum Dresden Klinik und Poliklinik für Dermatologie
🇩🇪Dresden, Germany
Universitätshautklinik Magdeburg
🇩🇪Magdeburg, Germany
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
University of Minnesota Masonic Cancer Center
🇺🇸Minneapolis, Minnesota, United States
University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University Hospitals Cleveland Medical Center - Seidman Cancer center
🇺🇸Cleveland, Ohio, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Mary Crowley Cancer Research Center
🇺🇸Dallas, Texas, United States
The Tweed Hospital
🇦🇺Tweed Heads, New South Wales, Australia
Universitätshautklinik Frankfurt
🇩🇪Frankfurt, Germany
Liverpool Hospital
🇦🇺Westmead, New South Wales, Australia
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Utah Health Care - Huntsman Cancer institute
🇺🇸Salt Lake City, Utah, United States
University of Alabama School of Medicine
🇺🇸Birmingham, Alabama, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States