Status:
COMPLETED
UCDCC#271: Phase I/II Trial of Epacadostat, Intralesional SD101, Radiotherapy in Patients With Lymphoma
Lead Sponsor:
University of California, Davis
Conditions:
Advanced Solid Tumors
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Adults \>18 years of age with histologically proven solid malignancy, high-grade lymphoma or low-grade lymphoma.
- Patients with incurable, advanced or metastatic disease refractory to at least one previous line of standard of care therapy.
- ECOG (Eastern Cooperative Oncology Group) performance status score of 0 - 2 (Appendix 1).
- Presence of a candidate treatment lesion (subcutaneous, nodal, or visceral) accessible and safe for radiotherapy and serial intralesional injections as specified by the protocol.
- Presence of at least one target lesion (distinct from treatment lesion and outside of treatment lesion radiation field) evaluable for response by irRECIST.
- 14 day wash-out period from any previous chemotherapy, targeted therapy or radiotherapy, 21 day washout period from previous immunotherapy.
- Life expectancy ≥ 6 months.
- Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days of the first study treatment:
- o ANC \> 1500 cells/ul; WBC count \> 2500/uL; Lymphocyte count \>500/uL; Platelet count \> 100,000/uL; Hemoglobin \> 9 g/dL
- Liver function tests meeting one of the following criteria:
- AST and ALT \< 2.5 x ULN with alkaline phosphatase \< 2.5 x ULN OR
- AST and ALT \< 1.5 x ULN, with alkaline phosphatase \> 2.5 x ULN
- Serum bilirubin \< 1.0 x ULN. Direct bili \< 40% if total bili \> ULN in patients with Gilbert's syndrome.
- INR and aPTT \< 1.5 x ULN.
- Serum Cr \< 1.5 X ULN or CrCl \> 50 ml/min.
- No active auto-immune disease and not on therapy for auto-immune disease. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible. Patients who have adrenal insufficiency and hypophysitis from prior immunotherapy if they are on stable medical replacement doses are eligible.
- No other active malignancy.
- Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible.
- For female patients of childbearing potential and male patients with partners of childbearing potential agreement (by patient and/or partner) to use highly effective form(s) of contraception (i.e., one that results in a low failure rate \[\<1% per year\] when used consistently and correctly) and to continue its use for 6 months after trial completion.
- Signed informed consent.
- At least 9 months from stem cell transplant with no active graft versus host disease.
- Ability to comply with the protocol.
Exclusion
- Uncontrolled concomitant disease that in the opinion of the investigator would interfere with the patient's safety or compliance on trial.
- Significant cardiovascular disease (NYHA Class II or greater); myocardial infarction within 3 month prior to randomization, unstable arrhythmias, unstable angina or a patient with a known LVEF (Left Ventricular Ejection Fraction) \< 40%
- Severe infection that in the opinion of the investigator would interfere with the patients safety or compliance on trial within 2 weeks prior to enrollment. Oral or IV antibiotics within 2 weeks or 5 half-lives prior to enrollment.
- Active tuberculosis
- History of severe autoimmune disease that in the opinion of the investigator would interfere with patient safety or compliance on trial.
- Positive for Human Immunodeficiency Virus (HIV), Hepatitis B (Hepatitis B Surface Antigen \[HBsAg\] reactive), or Hepatitis C virus (Hepatitis C Virus Ribonucleic Acid \[HCV RNA\] (qualitative) is detected)
- Previous treatment with epacadostat, SD-101, or any other IDO inhibitor or CpG molecule.
- Treatment with systemic corticosteroids or other systemic immunosuppressive medications within past 4 weeks or 5 half-lives whichever is shorter. Use of inhaled or topical steroids or systemic corticosteroids \< 10 mg/ day of prednisone (or equivalent) is permitted.
- Pregnant and/or lactating women.
- Evidence of active interstitial lung disease or active non-infectious pneumonitis
- Receipt of live attenuated vaccine within 30 days before the first dose of study treatment.
- Use of any UGT1A9 inhibitor while on active study treatment, including the following: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid.
- Known allergy or reaction to any component of either study drug formulation.
- Subjects receiving Monoamine Oxidase Inhibitors (MAOIs) or drug which has significant MAOI activity (meperidine, linezolid, methylene blue) from 21 days prior to Day 1 through 2 weeks after the final dose of epacadostat has been administered.
- Any history of Serotonin Syndrome (SS) after receiving serotonergic drugs.
- Known contraindications to radiotherapy including but not limited to radiation sensitivity syndromes such as xeroderma pigmentosum and ataxia telangiectasia mutated.
Key Trial Info
Start Date :
January 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03322384
Start Date
January 17 2018
End Date
April 8 2020
Last Update
February 1 2022
Active Locations (1)
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1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817