IRB #

STUDY00022389

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

Eric Roeland

Study Purpose

The purpose of the study is to learn the safety of an investigational drug called cavrotolimod (will be referred to as the study drug) when it is given with a standard treatment for advanced cancer called pembrolizumab or cemiplimab. We are hoping to find out what effects, good and/or bad, the study drug has on you and your cancer in combination with pembrolizumab or cemiplimab.

Medical Condition(s)

- locally advanced or metastatic Merkel cell carcinoma
- locally advanced or metastatic cutaneous squamous cell carcinoma
- locally advanced or metastatic Merkel cell carcinoma or advanced or metastatic melanoma

Eligibility Criteria

1. Individuals 18 years of age or older.
2. Adequate organ function
3. One tumor lesion amenable to repeated intratumoral injection
4. Other criteria apply

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Your participation in the study will be based on how your disease progresses or improves. The maximum duration of treatment with the study drug and pembrolizumab or cemiplimab is two years. The last study visit will be 90 days after treatment is stopped. After the last study visit, you will be contacted by telephone every 3 months, and information on your cancer that are obtained in your routine clinical care may be collected for the study.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080
trials@ohsu.edu

Sponsor

Exicure

Recruitment End

12/31/2021

Compensation Provided

No


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