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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

NCT02521870 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2021-08-03

Study results available
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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

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Antoni Ribas, MD · UCLA School of Medicine (Melanoma)

  • Ezra Cohen, MD · UCSD Moores Cancer Center (HNSCC)

  • Thomas Tüting, MD · University Hospital Magdeburg

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • United States
  • Australia
  • Germany
  • New Zealand

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02521870 on ClinicalTrials.gov