Clinical trial NCT03354936: ANRS CO24 OncoVIHAC (Onco VIH Anti Checkpoint)
Official title: A Multicenter Observational Cohort for HIV Infected Patients With a Cancer Treated by Immune-Checkpoint Inhibitors.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infected Patients With Cancer Treated by ICPi
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Pitié-Salpêtrière Hospital
name: Bicetre Hospital
First posted: 2017-11-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV Infected Patients with a Cancer treated by Immune-Checkpoint Inhibitors.

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

Eligibility 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

Primary outcomes:
measure: Incidence of clinical and biological adverse events occurring with ICPi treatment during the study period
timeFrame: 4.5 years
Secondary outcomes:
measure: Immuno-virological evolution
timeFrame: between Month0 and Month24
measure: Immuno-virological evolution
timeFrame: between Month0 and Month 24
measure: Disease status
timeFrame: at Month12 and at Month24
measure: Progression-Free survival
timeFrame: at Month6, Month12, Month18, Month24
measure: For Physiopathological Substudy "OncoVIRIM" : Objective Response Rate (OPR)
timeFrame: 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
measure: For Physiopathological Substudy "OncoVIRIM" : Detailed Immunological and Virological Evolution
timeFrame: 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
measure: For Physiopathological Substudy "OncoVIRIM" : Detailed Immunological and Virological Evolution
timeFrame: 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
measure: For Physiopathological Substudy "OncoVIRIM" : Detailed Immunological and Virological Evolution
timeFrame: 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
measure: For Physiopathological Substudy "OncoVIRIM" :
timeFrame: between Month0 and Month24
measure: For Physiopathological Substudy "OncoVIRIM" : Gene sequencing
timeFrame: Week0
Other outcomes:
Locations:
city: La Réunion
country: France
facility: Service d'Immunologie - Hôpital Felix Guyon
state: Saint-Denis
city: Aix-en-Provence
country: France
facility: Service d'Hématologie Oncologie - Centre Hospitalier du Pays d'Aix
city: Argenteuil
country: France
facility: Service de pneumologie - Hôpital Victor Dupouy
city: Avignon
country: France
facility: Service d'Onco-Hématologie Immunodépression - Hôpital Henri Duffaut
city: Besançon
country: France
facility: Service des Maladies Infectieuses et Tropicales - Hôpital Jean Minjoz
city: Cayenne
country: France
facility: Pôle de Médecine 2 - Centre Hospitalier Andrée Rosemon
city: Clamart
country: France
facility: Service de Médecine interne - Hôpital Antoine Béclère
city: Clermont-Ferrand
country: France
facility: Service d'hématologie - Hôpital Gabriel Montpied
city: Clermont-Ferrand
country: France
facility: Service des Maladies Infectieuses et Tropicales - Hôpital Gabriel Montpied
city: Créteil
country: France
facility: Service d'Immunologie Clinique - Hôpital Henri Mondor
city: Créteil
country: France
facility: Service de Médecine interne - Centre Hospitalier Intercommunal
city: Créteil
country: France
facility: Service de pneumologie - Centre Hospitalier Intercommunal
city: Créteil
country: France
facility: Service Hémopathies Lymphoïdes - Hôpital Henri Mondor
city: Créteil
country: France
facility: Service Oncologie Médicale - Centre Hospitalier Intercommunal
city: Le Chesnay
country: France
facility: Service de Médecine interne et Maladies infectieuses - Hôpital André Mignot
city: Le Chesnay
country: France
facility: Service d'hématologie et oncologie - Hôpital André Mignot
city: Le Kremlin-Bicêtre
country: France
facility: Service de Médecine interne-Immunologie clinique - Hôpital Bicêtre
city: Lyon
country: France
facility: Service des Maladies Infectieuses et Tropicales - Hôpital de la Croix Rousse
city: Marseille
country: France
facility: Ambulatoire-Hôpital de Jour - Institut Paoli Calmettes
city: Marseille
country: France
facility: Service d'hématologie-Cisih - Hôpital Sainte Marguerite
city: Marseille
country: France
facility: Service de dermatologie - Hôpital St Joseph
city: Marseille
country: France
facility: Service de Pneumologie - Hôpital St Joseph
city: Marseille
country: France
facility: Chirurgie Urologique et Tranplantation Rénale - Hôpital de la Conception
city: Marseille
country: France
facility: Service d'Oncologie médicale - Hôpital de la Timone
city: Marseille
country: France
facility: Service dermatologie/vénéréologie - Hôpital de la Timone
city: Marseille
country: France
facility: Service d'oncologie multidiscliplinaire - Hôpital Nord
city: Martigues
country: France
facility: Service de Médecine Interne - Centre Hospitalier de Martigues
city: Montpellier
country: France
facility: Service des Maladies Infectieuses et Tropicales - Hôpital Gui de Chauliac
city: Nice
country: France
facility: Service de Dermatologie - Hôpital l'Archet
city: Nice
country: France
facility: Service de médecine interne Cancérologie - Hôpital l'Archet
city: Nice
country: France
facility: Service des Maladies Infectieuses et Tropicales - Hôpital l'Archet
city: Paris
country: France
facility: Service des Maladies Infectieuses - Hôpital Saint Antoine
city: Paris
country: France
facility: Service Infectiologie - Hôpital de l'Hôtel-Dieu
city: Paris
country: France
facility: Service d'immuno-pathologie clinique - Hôpital Saint-Louis
city: Paris
country: France
facility: Service des Maladies Infectieuses - Hôpital Saint-Louis
city: Paris
country: France
facility: Servide de Dermatologie - Hôpital Saint-Louis
city: Paris
country: France
facility: Service d'Oncologie Médicale - Hôpital Pitié-Salpêtrière
city: Paris
country: France
facility: Service des Maladies Infectieuses et Tropicales - Hôpital Pitié-Salpêtrière
city: Paris
country: France
facility: Service Hématologie Clinique - Hôpital Pitié-Salpêtrière
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Service d'Immunologie Clinique - Hôpital européen Georges Pompidou
city: Paris
country: France
facility: Service de Cancérologie Médicale - Hôpital européen Georges Pompidou
city: Paris
country: France
facility: Service de pneumologie - Hôpital Tenon
city: Paris
country: France
facility: Service des Maladies Infectieuses et Tropicales - Hôpital Tenon
city: Saint-Brieuc
country: France
facility: Service de pneumologie - Hôpital Yves Le Foll
city: Saint-Brieuc
country: France
facility: Service Médecine interne - Maladies Infectieuses - Hôpital Yves Le Foll
city: Saint-Brieuc
country: France
facility: Service Oncologie Hématologie - Hôpital Yves Le Foll
city: Saint-Priest-en-Jarez
country: France
facility: Centre Hospitalier Universitaire de Saint Etienne
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
city: Strasbourg
country: France
facility: Le Trait d'Union - Hôpitaux Universitaires de Strasbourg
city: Suresnes
country: France
facility: Service de Médecine Interne - Hôpital Foch
city: Suresnes
country: France
facility: Service de Pneumologie - Hôpital Foch
city: Toulon
country: France
facility: Service de Médecine Interne - Hôpital d'Instruction des Armées Saint Anne
city: Toulouse
country: France
facility: Service des Maladies Infectieuses et Tropicales - Hôpital Purpan
city: Tourcoing
country: France
facility: Service des Maladies Infectieuses et du Voyageur - Centre Hospitalier de Tourcoing
city: Villejuif
country: France
facility: Département d'Innovation Thérapeutique et d'Essais Précoces - Institut Gustave Roussy
Study officials:
affiliation: GH Pitié-Salpêtrière-Charles Foix
name: Jean-Philippe SPANO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Bicêtre
name: Olivier LAMBOTTE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: