Phase 1/2 Study of Intratumoral G100 With or Without Pembrolizumab in Patients with Follicular Non-Hodgkin's Lymphoma
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.
Follicular Non-Hodgkin's Lymphoma
- 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
18 - 99
Healthy Volunteers Needed
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.
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