ANRS CO24 OncoVIHAC (Onco VIH Anti Checkpoint)

ANRS, Emerging Infectious Diseases

Status: Unknown

Conditions: HIV Infected Patients With Cancer Treated by ICPi

Treatments: Biological: Blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT03354936

2017-A00699-44

Details and patient eligibility

About

A Multicenter, Observational, National Cohort for HIV Infected Patients with a Cancer treated by Immune-Checkpoint Inhibitors (ICPi) for less than one month or to be treated with an ICPi such as anti-PD-1 or anti-PDL-1 or anti-CTLA4, monitored in some French hospitals .

The objective of the study is to assess the safety of these new agents in HIV-infected patients.

As an observatory, the number of participants planned is not predetermined: the aim is to include for 2 years any participant infected with HIV and having a cancer treated by ICPi in one of the centers that have agreed to participate.

50 participants will be recruited for Substudy "OncoVIRIM" during the study period (regardless of tumor type or ICPi type); 8 or 9 time points (blood samples) will be scheduled

The cohort " ANRS CO24 OncoVIHAC " is declared to authorities like category 2 research .

No intervention in the observatory, a collection of data will be carried out in M0, M6, M12, M18 and M24.

For the physiopathological Substudy OncoVIRIM : Blood samples will be collected to constitute cell bank, plasma bank, serum bank, DNA bank in order to meet the objectives of this substudy and possibly for complementary research

Full description

Primary Objective To evaluate clinical and biological safety of the use of immune checkpoint inhibitors in HIV infected patients with cancer treated by Immune-Checkpoint Inhibitors (ICPi).

Secondary objectives

• To evaluate evolution of HIV immunological and virological data in HIV infected patients with cancer treated by Immune-Checkpoint Inhibitors (ICPi):
• HIV-RNA plasma viral load
• Evolution of CD4+ and CD8+ T cells counts, CD4/CD8 ratio
• To assess the efficacy endpoint : progression-free survival, overall survival rate at 1 year and 2 years.
• Potential Modification of antiretroviral therapy

Secondary objectives of the Physiopathological Substudy "OncoVIRIM" (Limited to a few clinical centers with a suitable technical tray) :

• To evaluate response to ICPi treatment according to RECIST criteria (solid tumor) and CHESON criteria (lymphoma)
• Other immunological and virological explorations on HIV :
• To evaluate low level HIV replication and size of the HIV reservoir
• To evaluate effects of ICPi on HIV-specific immune responses
• To show the effects of ICPi on HIV-related immune alterations such as T cell differentiation, T cell activation/exhaustion and systemic inflammation
• To demonstrate an effect on other viruses-specific T cells and viremia (EBV, CMV, HHV-8, HBV et HCV (if co-infected)
• To better understand the pathophysiology of ICPi-related immune adverse effects, particularly the development of infraclinical auto-immunity : monitoring of autoantibodies and analysis of changes in B cell antibodies repertoires
• To find immune biomarkers predictive for clinical response to ICPi, MHC class I and II in particular and description of any gene of interest in the context of ICPi treatment

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Study Population for Cohort

Inclusion criteria :

• Age ≥ 18 years
• Documented HIV-1 infection treated or untreated with antiretrovirals
• Cancer histologically and /or cytologically proven
• Person treated for less than 30 days or who should be treated with anti-PD-1 or anti-PDL-1 or anti-CTLA4 according to current recommendations
• Signed informed consent

Exclusion Criteria

• Subject participating in clinical trials "CHIVA 2" (Lung Cancer- IFCT) and "HANOVRE" (Hodgkin's disease - LYSA)

Study Population for the Physiopathological Substudy "OncoVIRIM":

Inclusion criteria:

• Participant included in the observatory
• Stable antiretroviral therapy (ART) with controlled HIV-RNA plasma viral load ≤ 50 copies/mL
• Beneficiary of a Social Security program (State Medical Aid or AME is not a Social Security program), article L1121-11 of the Public health code...
• Signed informed consent.

Non Inclusion Criteria

• Brain or lung radiotherapy < 30 days
• Transplant organ or bone marrow transplant
• Corticosteroid > 10 mg per day
• Participant who started ICPi treatment prior to inclusion in the observatory