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Immune Checkpoint Inhibitors

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

Blood sample

Joséphine Anna TINE

Safa LASSOUED

Catherine GAUD, MD

Thierry ALLEGRE, MD

Laure BELMONT, MD

Gilles PICHANCOURT, MD

Catherine CHIROUZE, MD

Béatrice VIRJOGHE, MD

Jean-François BOUE, MD

Cécile MOLUCON-CHABROT, MD

Christine JACOMET, MD

Jean-Daniel LELIEVRE, MD

Valérie GARRAIT, MD

Valérie GARRAIT

Isabelle MONNET, MD

Corinne HAIOUN, MD

Isabelle COJEAN-ZELEK

Isabelle COJEAN-ZELEK, MD

Alix GREDER-BELAN, MD

Caroline BESSON, MD

Olivier LAMBOTTE, MD

Laurent COTTE, MD

Jean-François MOULIN, MD

Isabelle POIZOT-MARTIN, MD

Frank TOLLINCHI, MD

Christina AUDOLY, MD

Eric LECHEVALLIER, MD

Jean-Laurent DEVILLE, MD

Jean-Jacques GROB, MD

Laurent GREILLIER, MD

Rolande COHEN VALENSI, MD

Alain MAKINSON, MD

Alexandra PICARD, MD

Eric ROSENTHAL, MD

Alissa NAQVI, MD

Karine LACOMBE, MD

Dominique SALMON-CERON, MD

Laurence GERARD, MD

Diane PONSCARME, MD

Céleste LEBBE, MD

Jean-Philippe SPANO, MD

Jean-Philippe Spano, MD

Christine KATLAMA, MD

Sylvain CHOQUET

Sylvain CHOQUET, MD

Yazdan YAZDANPANAH, MD

Laurence WEISS, MD

Stéphane OUDARD, MD

Armelle LAVOLE, MD

Gilles PIALOUX, MD

Gwenaëlle LE GARFF, MD

Corinne DANIEL, MD

Corinne ALLEAUME, MD

Anne FRESARD, MD

Pierre FOURNEL, MD

Marie-Laure BATARD, MD

David ZUCMAN, MD

Jean-Louis COUDERC, MD

Jean-Pierre DE JAUREGUIBERRY, MD

Pierre DELOBEL, MD

Faïza AJANA, MD

Aurélien MARABELLE, MD

Jean-Philippe SPANO, MD, PhD

Olivier LAMBOTTE, MD, PhD

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

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

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.

ANRS CO24 OncoVIHAC (Onco VIH Anti Checkpoint)

A Multicenter Observational Cohort for HIV Infected Patients With a Cancer Treated by Immune-Checkpoint Inhibitors.

CD4+ and CD8+ T cells counts /mm3 and %, CD4/CD8 ratio.

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

- 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.

- Anti-HIV Specific Immune Responses T cell (polyfunctionality and expression of immune checkpoints)

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.

- 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.

Incidence of autoimmune complications and changes in antibodies repertoires of B cell in case of immunological adverse event

Gene sequencing whose interest appears to be major in the responses / adverse effects of ICPi, especially MHC class I and II

Pitié-Salpêtrière Hospital

Bicetre Hospital

ANRS, Emerging Infectious Diseases

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
ANRS CO24 OncoVIHAC (Onco VIH Anti Checkpoint)	NCT03354936	HIV Infected Pa...	Blood sample	18 Years -	ANRS, Emerging Infectious Diseases
ANRS CO24 OncoVIHAC (Onco VIH Anti Checkpoint)	NCT03354936	HIV Infected Pa...	Blood sample	18 Years -	ANRS, Emerging Infectious Diseases

Spots Global Cancer Trial Database for hiv infected patients with cancer treated by icpi