The company pulled durvalumab from heme malignancies

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

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.