Durvalumab in Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cancer
- HIV
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Durvalumab will be supplied in glass vials containing 500 mg of liquid solution at a concentration of 50 mg/mL for intravenous(IV) administrationMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PD-1/ PD-L1 coinhibitory pathway plays a significant role in the regulation of the immune response in both chronic infectious diseases and cancer. Preclinical and animal data support the safety and promising activity of anti-PD-1 antibody in HIV-1 infection. Demonstrated anticancer activity and safe...
PD-1/ PD-L1 coinhibitory pathway plays a significant role in the regulation of the immune response in both chronic infectious diseases and cancer. Preclinical and animal data support the safety and promising activity of anti-PD-1 antibody in HIV-1 infection. Demonstrated anticancer activity and safety profile of durvalumab (MEDI4736) in cancer clinical trials. Unlikely drug interactions of durvalumab (MEDI4736) and antiretroviral treatments. 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. In this regard, our hypothesis is: HIV patients with cancer have a similar outcome in terms of tolerability when treated with durvalumab (MEDI4736) monotherapy at the recommended dose than non HIV infected patients.
Tracking Information
- NCT #
- NCT03094286
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: María González-Cao, MD Instituto Oncológico Dr Rosell
Get Well Soon