HIV Infected Patients With Cancer Treated by ICPi
Conditions
Brief summary
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
Detailed 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
Interventions
BIOLOGICALBlood sample
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
Sponsors
Pitié-Salpêtrière Hospital
Bicetre Hospital
ANRS, Emerging Infectious Diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of clinical and biological adverse events occurring with ICPi treatment during the study period | 4.5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease status | at Month12 and at Month24 | Overall response rate |
| Progression-Free survival | at Month6, Month12, Month18, Month24 | Progression-Free survival rate |
| For Physiopathological Substudy OncoVIRIM : Objective Response Rate (OPR) | At following cures cycles according to the type of treatment : Cycle1 (Week0), Cycle2 (Week2 or Week3), Cycle3 (Week4 or Week6), Cycle9 (Week16) or Cycle9 (Week24), Cycle 15(Week28), Cycle18 (Week52), Cycle27 (Week52), Cycle36 (Week104), Month6, Month12 | Objective response rate of patient tumor with ICPi treatment according to RECIST criteria (solid tumor) et CHESON criteria (lymphoma). The cycles of cures concerned according to the type of treatment : * Nivolumab with a cure cycle length of 2 weeks : Cycle1(Week0), Cycle2 (Week2), Cycle3 (Week4), Cycle9 (Week16), Cycle15 (Week28), Cycle27 (Week52), Cycle51 (Week100) * Pembrolizumab with a cure cycle length of 3 weeks : Cycle1 (Week0), Cycle2 (Week3), Cycle3 (Week6), Cycle9 (Week24), Cycle18 (Week52), Cycle36 (Week104) * Ipilimumab with a cure cycle length of 3 weeks : Cycle1 (Week0), Cycle2(Week3), Cycle3 (Week6), Cycle4 (Week9), Month6, Month12 |
| Immuno-virological evolution | between Month0 and Month24 | HIV-RNA plasma viral load copies/mL |
| For Physiopathological Substudy OncoVIRIM : | between Month0 and Month24 | Incidence of autoimmune complications and changes in antibodies repertoires of B cell in case of immunological adverse event |
| For Physiopathological Substudy OncoVIRIM : Gene sequencing | Week0 | Gene sequencing whose interest appears to be major in the responses / adverse effects of ICPi, especially MHC class I and II |
| For Physiopathological Substudy OncoVIRIM : Detailed Immunological and Virological Evolution | At following cures cycles according to the type of treatment : Cycle1 (Week0), Cycle2 (Week2 or Week3), Cycle3 (Week4 or Week6), Cycle9 (Week16) or Cycle9 (Week24), Cycle 15(Week28), Cycle18 (Week52), Cycle27 (Week52), Cycle36 (Week104), Month6, Month12 | \- Low level of HIV-RNA plasma viral load (ultrasensitive assay), HIV-DNA viral load in PBMCs (peripheral blood mononuclear cells) The cycles of cures concerned according to the type of treatment : * Nivolumab with a cure cycle length of 2 weeks : Cycle1 (Week0), Cycle2 (Week2), Cycle3 (Week4), Cycle9 (Week16), Cycle 15(Week28), Cycle27 (Week52), Cycle51 (Week100), in case of treatment stopped and in case of immunological adverse event. * Pembrolizumab with a cure cycle length of 3 weeks : Cycle1 (Week0), Cycle2 (Week3), Cycle3 (Week6), Cycle9 (Week24), Cycle18 (Week52), Cycle36 (Week104) in case of treatment stopped and in case of immunological adverse event. * Ipilimumab with a cure cycle length of 3 weeks : Cycle1 (Week0), Cycle2(Week3), Cycle3 (Week6), Cycle4 (Week9), Month 6, Month 12, in case of treatment stopped and in case of immunological adverse event. |
Countries
France
Contacts
Primary ContactJoséphine Anna TINE
Backup ContactSafa LASSOUED
Outcome results
None listed