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

Phase 1

Terminated

• Conditions: Metastatic Melanoma; Head 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

Study Timeline

• Study First Submitted: 2015-07-30
• Study First Submitted QC: 2015-08-10
• Study First Posted: 2015-08-13
• Study Start: 2015-09
• Primary Completion: 2020-04
• Study Completion: 2020-04
• Results First Submitted: 2021-04-30
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-12
• Last Update Submitted: 2021-07-12
• Results First Posted: 2021-08-03
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

Not provided

Exclusion Criteria

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)

University of Alabama School of Medicine; 🇺🇸 Birmingham, Alabama, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

University of Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

Stanford Hospitals and Clinics; 🇺🇸 Palo Alto, California, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Mount Sinai Comprehensive Cancer Center; 🇺🇸 Miami Beach, Florida, United States

Georgia Cancer Center - Northside Hospital Central Research Department; 🇺🇸 Atlanta, Georgia, United States

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