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

Exclusion Criteria39

• 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)