Durvalumab in HIV-1 Patients With Solid Tumors

Inclusion Criteria

• Written informed consent
• Age > 18 years at time of study entry.
• Eastern Cooperative Oncology Group (ECOG) 0-2
• Life expectancy of > 16 weeks
• Adequate normal organ and marrow function.
• Female subjects must either be of non-reproductive potential
• Subject is willing and able to comply with the protocol
• Subjects with histologically or cytologically advanced/metatasic-documented lung cancer, head and neck cancer, cervical cancer, melanoma, anal cancer, pancreatic cancer, gastrio-esophageal cancer, triple negative breast cancer, bladder or renal cancer, Cholangiocarcinoma, Kaposi sarcoma, lymphomas, ovarian cancer or Merkel cell carcinoma or any other tumor type in which anti PD-L1 antibodies have desmonstrated antitumoral activity, refractory to standard treatment, intolerant of standard treatment, or for which no standard therapy exists or who refuse the standard treatment.
• Subjects may be included irrespectively of number of previous lines of treatment for advanced disease.
• Prior palliative radiotherapy must have been completed at least 2 weeks prior to start the study treatment (subjects may receive localized palliative radiotherapy while receiving study drug).
• Documented HIV-1 infection.
• Undetectable viral load in the last analysis.
• Subjects with brain metastases are eligible if they are asymptomatic, are treated or are neurological stable for at least 2 weeks without the use of steroids or on stable or decreasing dose of Grade 1.
• Active or prior documented autoimmune disease within the past 2 years
• Any syndrome that requires systemic corticosteroid/immunosuppressive medications
• Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
• History of primary immunodeficiency.
• History of allogeneic organ transplant.
• History of hypersensitivity to durvalumab or any excipient.
• Uncontrolled intercurrent illness
• Known history of active tuberculosis.
• Any serious or uncontrolled medical disorder or active infection non HIV, that would impair the ability of the subject to receive the treatment of protocol therapy under treating physician criteria.
• Subjects with previous malignances, are excluded unless a complete remission was achieved at least 5 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.
• Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab.
• Female subjects who are pregnant, breast-feeding, male, or female patients of reproductive potential who are not employing an effective method of birth control.
• Symptomatic or uncontrolled brain metastases
• Subjects with uncontrolled seizures.
• Patients with tumoral disease in the head and neck region, such as peritracheal or periesophageal lymph node involvement,
• Patients with neuroendocrine tumors of pulmonary origin or pulmonary metastases with evidence of active bleeding
• Patients with digestive bleeding