18 and older, any sex, with Advanced Solid Tumors or Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Tolerated Dose (MTD)Primary· Up to 30 days of treatment
To determine the maximum tolerated dose (MTD) of epacadostat that can be given with radiotherapy and intralesional SD-101 immunotherapy for the phase I portion of the study. The MTD will be determined using a standard 3+3 design. Patients will be monitored weekly during a 30-day dose-limiting toxicity (DLT) period. MTD can be defined as The maximum dose at which \<2 of 6 patients experienced a DLT.
Group
Value
95% CI
Experimental
300
Incidence of Related Adverse Events [Safety and Tolerability]Primary· Through study completion, an average of one year
To characterize the safety profile of this regimen using CTCAE v4.03 (Common Toxicity Criteria for Adverse Events version 4.03) in the phase II expansion . The expansion phase (phase II) will be conducted using the MTD defined as the highest dose at which no more than one of six patients develops a DLT or Dose Level 1 if the MTD is not reached. Patients will be monitored every week during the first 30 days of study and then monthly thereafter up to a period of 1 year.
Group
Value
95% CI
Experimental
17
Abscopal Response RateSecondary· Through study completion, an average of one year
Abscopal Response Rate (ARR) is defined as objective response rate (the percentage of patient that achieve a partial or complete response) at unirradiated sites using irRECIST criteria using imaging obtained every 60 days during the 1 year study period.
Group
Value
95% CI
Experimental
4
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 1 year..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Experimental
Serious: 9/20 (45%)
Deaths: 10/20
Serious adverse events (11 terms)
Reaction
System
Experimental
Gastrointestinal disorders - Other, specify: lower GI bleed
Gastrointestinal disorders
—
Sepsis
Infections and infestations
—
Upper respiratory infection
Infections and infestations
—
Investigations - Other, specify: transanimitis
Investigations
—
Hyponatremia
Metabolism and nutrition disorders
—
Metabolism and nutrition disorders - Other, specify: electrolyte and fluid disorder
Metabolism and nutrition disorders
—
Generalized muscle weakness
Musculoskeletal and connective tissue disorders
—
Muscle weakness lower limb
Musculoskeletal and connective tissue disorders
—
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify:disease progres
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04586244 — An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Ur
· Phase 2
· terminated
NCT04463771 — Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Adva
· Phase 2
· active not recruiting
Other recruiting trials for Advanced Solid Tumors
Currently open trials in the same condition.
NCT07504445 — Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors
· EARLY_PHASE1
· recruiting
NCT07589530 — Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors
· Phase 1, PHASE2
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, Davis
Last refreshed: 1 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03322384.