drugset / Trial / NCT03322384

UCDCC#271: Phase I/II Trial of Epacadostat, Intralesional SD101, Radiotherapy in Patients With Lymphoma

NCT03322384

Phase 1/2 Completed 20 enrolled University of California, Davis
NaSingle-groupOpen-labelTreatment

Summary

Checkpoint blockade immunotherapy has revolutionized the management of a variety of advanced malignancies. Monoclonal antibodies targeting the PD-1 / PD-L1 interaction have received FDA approvals for non-small cell lung cancer, melanoma, Merkel cell carcinoma, renal cell carcinoma, hepatocellular, squamous cell carcinoma of the head and neck, microsatellite instability high colorectal carcinoma, urothelial carcinoma, and classical Hodgkin's lymphoma. Despite the promising evidence for deep and durable responses with these agents, the majority of patients either fail to respond or develop resistance to treatment. Thus, there is interested in developing alternative immunotherapeutic strategies. The investigators hypothesize that a novel immunotherapeutic combination of radiotherapy (RT) with intralesional CpG and indolamine-2,3-dioxygenase blockade may offer significant clinical benefit to patients and proposing a microtrial testing this combination for advanced/refractory solid tumors and lymphoma.

Timeline

Start
2018-01-17
Primary completion
2020-02-24
Completion
2020-04-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Epacadostat Small molecule 100 mg Oral
Subject Epacadostat Small molecule 200 mg Oral
Subject Epacadostat Small molecule 300 mg Oral
Subject Nelitolimod Oligonucleotide (other) 4 mg Other

Indications