Durvalumab in Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03094286|
Recruitment Status : Active, not recruiting
First Posted : March 29, 2017
Last Update Posted : November 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV Cancer||Drug: Durvalumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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) administration|
|Masking:||None (Open Label)|
|Official Title:||A PHASE II EXPLORATORY STUDY OF DURVALUMAB (MEDI4736) IN HIV-1 PATIENTS WITH ADVANCED SOLID TUMORS|
|Actual Study Start Date :||April 24, 2017|
|Actual Primary Completion Date :||April 24, 2019|
|Estimated Study Completion Date :||April 24, 2022|
Experimental: Arm 1
Durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients
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
Other Name: MEDI4736
- Number of HIV patient that receive durvalumab at least during 4 months [ Time Frame: From the first dose until progression disease (at 1 year approximately) ]To explore the feasibility of durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg in solid tumors in HIV-1-infected patients
- To assess Overall Response Rate (ORR) (RECIST 1.1 and irRECIST) [ Time Frame: From the first dose until the first response evaluation (8 weeks from the first dose) ]ORR according to RECIST criteria
- To evaluate the Progression Free Survival (PFS) rate [ Time Frame: From the first dose until the first response evaluation (8 weeks from the first dose) ]To evaluate progression free survival rate of all the patients included
- To evaluate the Overall Survival (OS) rate [ Time Frame: At month 12th from the first dose of Durvalumab ]To evaluate overall survival rate of all the patients included
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094286
|Badalona, Barcelona, Spain, 08916|
|Consorci Sanitari de Terrassa|
|Terrassa, Barcelona, Spain, 08220|
|H. Clínic i Provincial de Barcelona|
|Barcelona, Spain, 08036|
|H. Universitario Quirón Dexeus|
|Barcelona, Spain, 08036|
|Hospital Puerta de Hierro|
|Madrid, Spain, 28222|
|H. La Paz|
|Hospital Virgen del Rocío|
|Sevilla, Spain, 41013|
|Hospital La Fe|
|Principal Investigator:||María González-Cao, MD||Instituto Oncológico Dr Rosell|