Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneous or Peripheral T Cell Lymphoma

Exclusion Criteria

• •Immunotherapy with immune checkpoint inhibitors, cell-based therapies, or cancer vaccines
• •Lenalidomide, thalidomide or other immunomodulatory drugs (IMiDs)
• •Monoclonal antibody within 5 half-lives of the antibody prior to initiating protocol therapy
• •Any systemic therapy, including monoclonal antibody within 28 days or 5 half-lives (whichever is shorter) of initiating protocol therapy
• •Any skin-directed therapy within 14 days prior to initiating protocol therapy
• •Any radiation therapy within 21 days prior to initiating protocol therapy
• •Immunosuppressive medication within 14 days prior to the first dose of study treatment; the following are exceptions to this criterion:
• •* Intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection) and are on stable dose for at least 28 days
• •* Systemic corticosteroids at physiologic doses of \< 10 mg/day of prednisone or equivalent
• •Live, attenuated vaccine within 30 days prior to the first dose of protocol therapy
• •History of pneumonitis (non-infectious) that required steroids or current pneumonitis
• •Disease free of prior malignancies for \>= 5 years with the exception of:
• •* Currently treated squamous cell and basal cell carcinoma of the skin
• •* Carcinoma in situ of the cervix, or
• •* Surgically removed melanoma in situ of the skin (stage 0) with histological confirmed free margins of excision or
• •* Prostate cancer (T1a or T1b using the TNM \[tumor, nodes, metastasis\] clinical staging system) that has/have been surgically cured, or
• •* Any other malignancy that has/have been curatively treated with surgery and/or localized radiation
• •Allergic reaction/ hypersensitivity to thalidomide or to the excipients contained in the formulation of durvalumab
• •Female only: pregnant or lactating
• •Prior stem cell transplantation
• •Acute infection requiring systemic treatment
• •Known history of human immunodeficiency virus (HIV) infection
• •Active hepatitis B or C infection
• •Conditions requiring chronic steroid or immunosuppressive treatment that likely need additional steroid or immunosuppressive treatments in addition to the protocol therapy
• •Current peripheral neuropathy \>= grade 2
• •Renal failure requiring hemodialysis or peritoneal dialysis
• •Unstable cardiac disease as defined by one of the following:
• •* Cardiac events such as myocardial infarction (MI) within the past 6 months
• •* NYHA (New York Heart Association) heart failure class III-IV
• •* Uncontrolled atrial fibrillation or hypertension
• •Major surgery (as defined by the investigator) within the 28 days prior to the first dose of study treatment
• •Active or prior documented autoimmune or inflammatory disorders requiring therapy within the past 3 years prior to the start of treatment; the following are exceptions to this criterion:
• •* Vitiligo or alopecia;
• •* Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; or
• •* Psoriasis not requiring systemic treatment
• •History of primary immunodeficiency
• •Incidence of gastrointestinal disease that may significantly alter the absorption of lenalidomide
• •Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc
• •In the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)