At a glance
ClinicalIndex Comparison Record- ✓Age >18 years at study entry
- ✓ECOG performance status 0-2
- ✓Life expectancy >16 weeks
- ✓Advanced/metastatic solid tumor (lung, head/neck, cervical, melanoma, anal, pancreatic, gastric, TNBC, bladder, renal, cholangiocarcinoma, Kaposi sarcoma, lymphoma, ovarian, Merkel cell, or other with demonstrated anti-PD-L1 activity) refractory to, intolerant of, or without standard therapy
- ✕Prior treatment with PD-1, PD-L1, or PD-L2 inhibitors (including durvalumab)
- ✕Anti-cancer therapy within 28 days prior to first dose of study drug
- ✕QTc ≥470 ms
- ✕Immunosuppressive medication within 28 days before first dose of durvalumab
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Exploratory Study of Durvalumab (MEDI4736) in HIV-1 Patients With Advanced Solid Tumors.
In Brief
A Phase 2 clinical trial evaluating Durvalumab for HIV and Cancer. Completed, enrolled 20 participants across 8 sites.
Detailed 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.
Study Details
Timeline
Interventions
Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled