ANRS CO24 OncoVIHAC (Onco VIH Anti Checkpoint)
- Conditions
- HIV Infected Patients With Cancer Treated by ICPi
- Registration Number
- NCT03354936
- Lead Sponsor
- ANRS, Emerging Infectious Diseases
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of clinical and biological adverse events occurring with ICPi treatment during the study period 4.5 years
- Secondary Outcome Measures
Name Time Method Immuno-virological evolution between Month0 and Month 24 CD4+ and CD8+ T cells counts /mm3 and %, CD4/CD8 ratio.
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, Month12For 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" : 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 - Systemic inflammation markers and markers of T cell activation, exhaustion, and differentiation
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.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
Trial Locations
- Locations (56)
Service d'Immunologie - H么pital Felix Guyon
馃嚝馃嚪La R茅union, Saint-Denis, France
Service d'H茅matologie Oncologie - Centre Hospitalier du Pays d'Aix
馃嚝馃嚪Aix-en-Provence, France
Service de pneumologie - H么pital Victor Dupouy
馃嚝馃嚪Argenteuil, France
Service d'Onco-H茅matologie Immunod茅pression - H么pital Henri Duffaut
馃嚝馃嚪Avignon, France
Service des Maladies Infectieuses et Tropicales - H么pital Jean Minjoz
馃嚝馃嚪Besan莽on, France
Ambulatoire-H么pital de Jour - Institut Paoli Calmettes
馃嚝馃嚪Marseille, France
Service d'h茅matologie-Cisih - H么pital Sainte Marguerite
馃嚝馃嚪Marseille, France
Service dermatologie/v茅n茅r茅ologie - H么pital de la Timone
馃嚝馃嚪Marseille, France
Service de M茅decine interne - Centre Hospitalier Intercommunal
馃嚝馃嚪Cr茅teil, France
Service de pneumologie - Centre Hospitalier Intercommunal
馃嚝馃嚪Cr茅teil, France
Service de M茅decine interne - H么pital Antoine B茅cl猫re
馃嚝馃嚪Clamart, France
P么le de M茅decine 2 - Centre Hospitalier Andr茅e Rosemon
馃嚝馃嚪Cayenne, France
Service de M茅decine interne et Maladies infectieuses - H么pital Andr茅 Mignot
馃嚝馃嚪Le Chesnay, France
Service des Maladies Infectieuses et Tropicales - H么pital de la Croix Rousse
馃嚝馃嚪Lyon, France
Service d'h茅matologie - H么pital Gabriel Montpied
馃嚝馃嚪Clermont-Ferrand, France
Service des Maladies Infectieuses et Tropicales - H么pital Gabriel Montpied
馃嚝馃嚪Clermont-Ferrand, France
Service des Maladies Infectieuses et Tropicales - H么pital Piti茅-Salp锚tri猫re
馃嚝馃嚪Paris, France
Service H茅mopathies Lympho茂des - H么pital Henri Mondor
馃嚝馃嚪Cr茅teil, France
Service Oncologie H茅matologie - H么pital Yves Le Foll
馃嚝馃嚪Saint-Brieuc, France
Service des Maladies Infectieuses et Tropicales - H么pital Purpan
馃嚝馃嚪Toulouse, France
Service d'Immunologie Clinique - H么pital Henri Mondor
馃嚝馃嚪Cr茅teil, France
Service Infectiologie - H么pital de l'H么tel-Dieu
馃嚝馃嚪Paris, France
Service Oncologie M茅dicale - Centre Hospitalier Intercommunal
馃嚝馃嚪Cr茅teil, France
Service de M茅decine Interne - Centre Hospitalier de Martigues
馃嚝馃嚪Martigues, France
Service des Maladies Infectieuses et Tropicales - H么pital Gui de Chauliac
馃嚝馃嚪Montpellier, France
Service d'h茅matologie et oncologie - H么pital Andr茅 Mignot
馃嚝馃嚪Le Chesnay, France
Service de M茅decine interne-Immunologie clinique - H么pital Bic锚tre
馃嚝馃嚪Le Kremlin-Bic锚tre, France
Service d'oncologie multidiscliplinaire - H么pital Nord
馃嚝馃嚪Marseille, France
Service de Dermatologie - H么pital l'Archet
馃嚝馃嚪Nice, France
Service de m茅decine interne Canc茅rologie - H么pital l'Archet
馃嚝馃嚪Nice, France
Service d'Oncologie M茅dicale - H么pital Piti茅-Salp锚tri猫re
馃嚝馃嚪Paris, France
Service de dermatologie - H么pital St Joseph
馃嚝馃嚪Marseille, France
Service de Pneumologie - H么pital St Joseph
馃嚝馃嚪Marseille, France
Chirurgie Urologique et Tranplantation R茅nale - H么pital de la Conception
馃嚝馃嚪Marseille, France
Service d'Oncologie m茅dicale - H么pital de la Timone
馃嚝馃嚪Marseille, France
Service des Maladies Infectieuses et Tropicales - H么pital l'Archet
馃嚝馃嚪Nice, France
Service des Maladies Infectieuses - H么pital Saint Antoine
馃嚝馃嚪Paris, France
Service des Maladies Infectieuses - H么pital Saint-Louis
馃嚝馃嚪Paris, France
Service H茅matologie Clinique - H么pital Piti茅-Salp锚tri猫re
馃嚝馃嚪Paris, France
Service d'Immunologie Clinique - H么pital europ茅en Georges Pompidou
馃嚝馃嚪Paris, France
Servide de Dermatologie - H么pital Saint-Louis
馃嚝馃嚪Paris, France
H么pital Bichat
馃嚝馃嚪Paris, France
Service de pneumologie - H么pital Tenon
馃嚝馃嚪Paris, France
Service de pneumologie - H么pital Yves Le Foll
馃嚝馃嚪Saint-Brieuc, France
Service M茅decine interne - Maladies Infectieuses - H么pital Yves Le Foll
馃嚝馃嚪Saint-Brieuc, France
Centre Hospitalier Universitaire de Saint Etienne
馃嚝馃嚪Saint-Priest-en-Jarez, France
Service de M茅decine Interne - H么pital Foch
馃嚝馃嚪Suresnes, France
Service de M茅decine Interne - H么pital d'Instruction des Arm茅es Saint Anne
馃嚝馃嚪Toulon, France
Service de Canc茅rologie M茅dicale - H么pital europ茅en Georges Pompidou
馃嚝馃嚪Paris, France
Service des Maladies Infectieuses et Tropicales - H么pital Tenon
馃嚝馃嚪Paris, France
Institut de Canc茅rologie Lucien Neuwirth
馃嚝馃嚪Saint-Priest-en-Jarez, France
Service de Pneumologie - H么pital Foch
馃嚝馃嚪Suresnes, France
D茅partement d'Innovation Th茅rapeutique et d'Essais Pr茅coces - Institut Gustave Roussy
馃嚝馃嚪Villejuif, France
Le Trait d'Union - H么pitaux Universitaires de Strasbourg
馃嚝馃嚪Strasbourg, France
Service des Maladies Infectieuses et du Voyageur - Centre Hospitalier de Tourcoing
馃嚝馃嚪Tourcoing, France
Service d'immuno-pathologie clinique - H么pital Saint-Louis
馃嚝馃嚪Paris, France