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

University of Michigan Rogel Cancer Center

Status and phase: Withdrawn; Early Phase 1

Conditions: Cutaneous T Cell Lymphoma

Treatments: Drug: Durvalumab; Radiation: Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03235869

HUM00131550 (Other Identifier)

UMCC 2017.079

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Radiation Therapy + Durvalumab

Experimental group

Description:

Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions) Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days.

Treatment:

Drug: Durvalumab

Radiation: Radiation Therapy