Durvalumab in HIV-1 Patients With Solid Tumors (NCT03094286) | Clinical Trial Compass
CompletedPhase 2
Durvalumab in HIV-1 Patients With Solid Tumors
Spain20 participantsStarted 2017-04-24
Plain-language summary
The proposal is a phase II clinical study designed to assess the feasibility of durvalumab (MEDI4736) in HIV-1-infected individuals with solid tumors. Additionally, to obtain data that lets understand the possible benefit of this treatment in cancer patients and HIV infection, exploring if activity of durvalumab (MEDI4736) could be higher in cancer that has been produced at least in part due to the chronic immunosupression. Simultaneously, it will allow us to investigate the effect of disrupting this immunoregulatory pathway might have in reversing cancer pathways and HIV-specific T-cell function during persistent chronic HIV infection in humans.
Who can participate
Age range18 Years
SexALL
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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.
Exclusion criteria
What they're measuring
1
Best Response During the Treatment Period
Timeframe: From the first dose until last follow up, assessed up to 24 month