Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma

• Status: Withdrawn
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single arm, single stage pilot study of radiation therapy plus durvalumab for tumor-stage cutaneous T-cell lymphoma (CTCL).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Treatments: Antibodies, Monoclonal; Durvalumab

Criteria

Inclusion Criteria:

• Voluntarily provide written IRB-approved consent

• Age ≥ 18 years

• Histologically proven CTCL

• Stage IIB-IV CTCL with ≥2 cutaneous tumors assessable for response

• At least one cutaneous tumor amenable to radiation therapy. Must have at least 1 tumor assessable for response that will not undergo radiation.

• Adequate organ function

• Prior treatment is allowed if at least 4 weeks have elapsed since last chemotherapy and/or radiation and the subject has recovered from all treatment related toxicity

Exclusion Criteria:

• Prior allogeneic stem cell transplant.

• Prior treatment with a PD-1/PD-L1 inhibitor

• Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment.

• Current or prior use of immunosuppressive medication within 14 days prior to first dose of durvalumab.

• Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.

• History of hypersensitivity to durvalumab or any excipient

• Receipt of live attenuated vaccination within 30 days prior the first dose of durvalumab.

• Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control

• Male subjects who are not employing an effective method of birth control

• Uncontrolled current medical illness, including, but not limited to ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris,unstable cardiac arrhythmia and/or psychiatric illness or other condition that in the opinion of the investigator would limit compliance with study requirements.