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Intratumoral Cavrotolimod Combined With Pembrolizumab or Cemiplimab in Patients With Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors

NCT03684785 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2022-04-07

No results posted yet for this study

Summary

This is a phase 1b/2, open-label, two-part, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of intratumoral cavrotolimod injections alone and in combination with intravenous pembrolizumab or cemiplimab in patients with Merkel Cell Carcinoma, cutaneous squamous cell carcinoma, and advanced solid tumors.

Phase 1b of this trial is a 3+3 dose escalation study evaluating escalating or intermediate dose levels of cavrotolimod given with a fixed dose of pembrolizumab.

The Phase 2 dose expansion part of the study will consist of two primary cohorts of patients: Merkel cell carcinoma and cutaneous squamous cell carcinoma. Patients in the Merkel Cell Carcinoma cohort will receive IT cavrotolimod combined with a fixed, standard dose of pembrolizumab while the Cutaneous Squamous Cell Carcinoma cohort will receive IT cavrotolimod combined with a fixed, standard dose of cemiplimab. The Phase 2 dose expansion is designed to provide a preliminary estimate of efficacy in patients that have progressed on an anti-PD-(L)1 CPI.

Conditions

  • Advanced or Metastatic Merkel Cell Carcinoma
  • Advanced or Metastatic Cutaneous Squamous Cell Carcinoma
  • Advanced or Metastatic Melanoma
  • Advanced or Metastatic Head and Neck Squamous Cell Carcinoma
  • Advanced or Metastatic Solid Tumors

Interventions

DRUG

Cavrotolimod

Intratumorally dosed cavrotolimod.

BIOLOGICAL

Pembrolizumab

Pembrolizumab dosing as per the US prescribing information.

BIOLOGICAL

Cemiplimab

Cemiplimab dosing as per the US prescribing information.

DRUG

Cavrotolimod

Subcutaneously dosed cavrotolimod

Sponsors & Collaborators

  • Exicure, Inc.

    lead INDUSTRY

Principal Investigators

  • Exicure Inc. · Exicure, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-13
Primary Completion
2022-03-30
Completion
2022-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT03684785 on ClinicalTrials.gov