IRB #

STUDY00015315

Title

Phase 1/2 Study of Intratumoral G100 With or Without Pembrolizumab in Patients with Follicular Non-Hodgkin's Lymphoma

Principal Investigator

Craig Okada

Study Purpose

This research study is a Phase 1/2 clinical trial of an investigational agent called G100. The use of G100 for Follicular lymphoma (FL) is experimental. It has not been approved by the Food and Drug Administration (FDA) because not enough is known about it. G100 is a new agent that when injected into your tumor can stimulate your body’s immune system to react to your cancer. This immune response may then attack your cancer and stop it from growing. In this research study, the safety of different doses of G100 when injected into a FL tumor after local radiation therapy will be examined. In addition, the study will be investigating the effect of G100 treatment on the injected tumor and to see if there is an effect on other FL tumors that were not injected. In Part 2, participants will be randomly assigned to receive either G100 alone or G100 together with an antibody called Pembrolizumab to see if the combination of the two drugs is better than receiving just one.

Medical Condition(s)

Follicular Non-Hodgkin's Lymphoma

Eligibility Criteria

- Men and women at least 18 years of age
- Diagnosed with Follicular Non-Hodgkin's Lymphoma and have not yet received any treatment for it, or you are relapsed or refractory following at least one prior treatment
- Tumor mass(es) accessible for intratumoral injection and being considered for local radiation therapy and at least one additional site of disease outside the radiation field for assessment of distal (abscopal) response


Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

The initial treatment phase will last 11 weeks. There is also an optional additional 11 weeks of treatment. After treatment has completed, there will be long-term follow-up visits every 8 weeks.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Immune Design

Recruitment End

01/01/2030

Compensation Provided

No


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