Exicure_AST-008-102 (Solid Tumors) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out how an experimental drug called cavrotolimod works in your body and against your cancer when it is given alone or in combination pembrolizumab or cemiplimab.

What is the Condition Being Studied?

Solid Tumors

Who Can Participate in the Study?

Adults who:
- Are 18 years or older
- Have advanced solid tumor(s) that can't be removed surgically
.
For more information about who can join this study, please contact the study team at ivy.belskie@duke.edu

Age Group
Adults

What is Involved?

This study is split into 2 parts: a screening period and a dosing period.

If you choose to join this study, during the screening period you will:
- Have blood draws
- Have physical exams
- Have tissue samples taken from your tumor(s)
- Have a scan of your heart (electrocardiogram)
- Get images taken of your tumor(s), which may involve MRI or CT scans

If you are found to be eligible at the end of the screening period, you will begin the dosing period. The dosing period is broken up into several cycles.

- During Cycle 1, you will:
-- Participate in this cycle for 2 weeks
-- Get an injection of the study drug (cavrotolimod) once per week during this cycle

- During Cycles 2 and 3, you will:
-- Participate in each cycle for 3 weeks
-- Get an injection of the study drug once per week during these cycles
-- Get an infusion (IV) of pembrolizumab or cemiplimab in combination with the study drug during these cycles

- During Cycle 4 and each cycle afterward, you will:
-- Participate in each cycle for 3 weeks
-- Get an injection of the study drug once every 3 weeks during these cycles
-- Get an infusion (IV) of pembrolizumab or cemiplimab in combination with the study drug during these cycles

The dosing period for this study will last a maximum of 2 years. Dosing will be less than 2 years if your cancer improves, or if we stop giving you the study treatment because your cancer is worsening, or if you choose to leave the study.

We will schedule you to come in for follow-up visits for about 3 months after you stop taking the study drugs. We call you every 3 months after your last follow-up visit to see how you are doing.

Study Details

Full Title
Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors: A Phase 1b/2 Study of Cavrotolimod Combined with Pembrolizumab or Cemiplimab
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00106737
NCT: NCT03684785
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698