ANRS CO24 OncoVIHAC (Onco VIH Anti Checkpoint) (OncoVIHAC)

January 24, 2018 updated by: ANRS, Emerging Infectious Diseases

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

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

Study Overview

Status

Unknown

Conditions

HIV Infected Patients With Cancer Treated by ICPi

Intervention / Treatment

Biological: Blood sample

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

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Aix-en-Provence, France, 13616
    - Recruiting
    - Service d'Hématologie Oncologie - Centre Hospitalier du Pays d'Aix
    - Contact:
      
      Thierry ALLEGRE, MD
    - Principal Investigator:
      
      Thierry ALLEGRE, MD
  - Argenteuil, France, 95100
    - Recruiting
    - Service de pneumologie - Hôpital Victor Dupouy
    - Principal Investigator:
      
      Laure BELMONT, MD
    - Contact:
      
      Laure BELMONT, MD
  - Avignon, France, 84000
    - Not yet recruiting
    - Service d'Onco-Hématologie Immunodépression - Hôpital Henri Duffaut
    - Contact:
      
      Gilles PICHANCOURT, MD
    - Principal Investigator:
      
      Gilles PICHANCOURT, MD
  - Besançon, France, 25030
    - Not yet recruiting
    - Service des Maladies Infectieuses et Tropicales - Hôpital Jean Minjoz
    - Contact:
      
      Catherine CHIROUZE, MD
    - Principal Investigator:
      
      Catherine CHIROUZE, MD
  - Cayenne, France, 97306
    - Not yet recruiting
    - Pôle de Médecine 2 - Centre Hospitalier Andrée Rosemon
    - Principal Investigator:
      
      Béatrice VIRJOGHE, MD
  - Clamart, France, 92141
    - Not yet recruiting
    - Service de Médecine interne - Hôpital Antoine Béclère
    - Contact:
      
      Jean-François BOUE, MD
    - Principal Investigator:
      
      Jean-François BOUE, MD
  - Clermont-Ferrand, France, 63000
    - Not yet recruiting
    - Service d'hématologie - Hôpital Gabriel Montpied
    - Contact:
      
      Cécile MOLUCON-CHABROT, MD
    - Principal Investigator:
      
      Cécile MOLUCON-CHABROT, MD
  - Clermont-Ferrand, France, 63000
    - Not yet recruiting
    - Service des Maladies Infectieuses et Tropicales - Hôpital Gabriel Montpied
    - Contact:
      
      Christine JACOMET, MD
    - Principal Investigator:
      
      Christine JACOMET, MD
  - Créteil, France, 94010
    - Recruiting
    - Service d'Immunologie Clinique - Hôpital Henri Mondor
    - Principal Investigator:
      
      Jean-Daniel LELIEVRE, MD
    - Contact:
      
      Jean-Daniel LELIEVRE, MD
  - Créteil, France, 94010
    - Not yet recruiting
    - Service de Médecine interne - Centre Hospitalier Intercommunal
    - Principal Investigator:
      
      Valérie Garrait
    - Contact:
      
      Valérie GARRAIT, MD
  - Créteil, France, 94010
    - Not yet recruiting
    - Service de pneumologie - Centre Hospitalier Intercommunal
    - Principal Investigator:
      
      Isabelle MONNET, MD
  - Créteil, France, 94010
    - Recruiting
    - Service Hémopathies Lymphoïdes - Hôpital Henri Mondor
    - Contact:
      
      Corinne Haioun, MD
    - Principal Investigator:
      
      Corinne HAIOUN, MD
  - Créteil, France, 94010
    - Not yet recruiting
    - Service Oncologie Médicale - Centre Hospitalier Intercommunal
    - Contact:
      
      Isabelle COJEAN-ZELEK
    - Principal Investigator:
      
      Isabelle COJEAN-ZELEK, MD
  - Le Chesnay, France, 78150
    - Recruiting
    - Service de Médecine interne et Maladies infectieuses - Hôpital André Mignot
    - Contact:
      
      Alix Greder-Belan, MD
    - Principal Investigator:
      
      Alix Greder-Belan, MD
  - Le Chesnay, France, 78151
    - Recruiting
    - Service d'hématologie et oncologie - Hôpital André Mignot
    - Contact:
      
      Caroline BESSON, MD
    - Principal Investigator:
      
      Caroline BESSON, MD
  - Le Kremlin-Bicêtre, France, 94276
    - Recruiting
    - Service de Médecine interne-Immunologie clinique - Hôpital Bicêtre
    - Contact:
      
      Olivier LAMBOTTE, MD
    - Principal Investigator:
      
      Olivier LAMBOTTE, MD
  - Lyon, France, 69317
    - Not yet recruiting
    - Service des Maladies Infectieuses et Tropicales - Hôpital de la Croix Rousse
    - Contact:
      
      Laurent COTTE, MD
    - Principal Investigator:
      
      Laurent COTTE, MD
  - Marseille, France, 13273
    - Not yet recruiting
    - Ambulatoire-Hôpital de Jour - Institut Paoli Calmettes
    - Contact:
      
      Jean-François MOULIN, MD
    - Principal Investigator:
      
      Jean-François MOULIN, MD
  - Marseille, France, 13274
    - Recruiting
    - Service d'hématologie-Cisih - Hôpital Sainte Marguerite
    - Contact:
      
      Isabelle POIZOT-MARTIN, MD
    - Principal Investigator:
      
      Isabelle POIZOT-MARTIN, MD
  - Marseille, France, 13285
    - Recruiting
    - Service de dermatologie - Hôpital St Joseph
    - Contact:
      
      Frank TOLLINCHI, MD
    - Principal Investigator:
      
      Frank TOLLINCHI, MD
  - Marseille, France, 13285
    - Recruiting
    - Service de Pneumologie - Hôpital St Joseph
    - Contact:
      
      Christina AUDOLY, MD
    - Principal Investigator:
      
      Christina AUDOLY, MD
  - Marseille, France, 13385
    - Recruiting
    - Chirurgie Urologique et Tranplantation Rénale - Hôpital de la Conception
    - Contact:
      
      Eric LECHEVALLIER, MD
    - Principal Investigator:
      
      Eric LECHEVALLIER, MD
  - Marseille, France, 13385
    - Recruiting
    - Service d'Oncologie médicale - Hôpital de la Timone
    - Contact:
      
      Jean-Laurent DEVILLE, MD
    - Principal Investigator:
      
      Jean-Laurent DEVILLE, MD
  - Marseille, France, 13385
    - Recruiting
    - Service dermatologie/vénéréologie - Hôpital de la Timone
    - Contact:
      
      Jean-Jacques Grob, MD
    - Principal Investigator:
      
      Jean-Jacques GROB, MD
  - Marseille, France, 13915
    - Recruiting
    - Service d'oncologie multidiscliplinaire - Hôpital Nord
    - Principal Investigator:
      
      Laurent Greillier, MD
    - Contact:
      
      Laurent GREILLIER, MD
  - Martigues, France, 13695
    - Recruiting
    - Service de Médecine Interne - Centre Hospitalier de Martigues
    - Contact:
      
      Rolande COHEN VALENSI, MD
    - Principal Investigator:
      
      Rolande COHEN VALENSI, MD
  - Montpellier, France, 34295
    - Recruiting
    - Service des Maladies Infectieuses et Tropicales - Hôpital Gui de Chauliac
    - Contact:
      
      Alain MAKINSON, MD
    - Principal Investigator:
      
      Alain MAKINSON, MD
  - Nice, France, 06202
    - Recruiting
    - service de Dermatologie - Hôpital l'Archet
    - Contact:
      
      Alexandra PICARD, MD
    - Principal Investigator:
      
      Alexandra PICARD, MD
  - Nice, France, 06202
    - Recruiting
    - Service de médecine interne Cancérologie - Hôpital l'Archet
    - Contact:
      
      Eric ROSENTHAL, MD
    - Principal Investigator:
      
      Eric ROSENTHAL, MD
  - Nice, France, 06202
    - Recruiting
    - Service des Maladies Infectieuses et Tropicales - Hôpital l'Archet
    - Contact:
      
      Alissa NAQVI, MD
    - Principal Investigator:
      
      Alissa NAQVI, MD
  - Paris, France, 75877
    - Recruiting
    - Hôpital Bichat
    - Contact:
      
      Yazdan YAZDANPANAH, MD
    - Principal Investigator:
      
      Yazdan YAZDANPANAH, MD
  - Paris, France, 75012
    - Recruiting
    - Service des Maladies Infectieuses - Hôpital Saint Antoine
    - Contact:
      
      Karine LACOMBE, MD
    - Principal Investigator:
      
      Karine LACOMBE, MD
  - Paris, France, 75101
    - Recruiting
    - Service Infectiologie - Hôpital de l'Hôtel-Dieu
    - Contact:
      
      Dominique SALMON-CERON, MD
    - Principal Investigator:
      
      Dominique SALMON-CERON, MD
  - Paris, France, 75475
    - Recruiting
    - Service d'immuno-pathologie clinique - Hôpital Saint-Louis
    - Contact:
      
      Laurence GERARD, MD
    - Principal Investigator:
      
      Laurence GERARD, MD
  - Paris, France, 75475
    - Recruiting
    - Service des Maladies Infectieuses - Hôpital Saint-Louis
    - Contact:
      
      Diane PONSCARME, MD
    - Principal Investigator:
      
      Diane PONSCARME, MD
  - Paris, France, 75475
    - Not yet recruiting
    - Servide de Dermatologie - Hôpital Saint-Louis
    - Contact:
      
      Celeste Lebbe, MD
    - Principal Investigator:
      
      Celeste Lebbe, MD
  - Paris, France, 75651
    - Recruiting
    - Service d'Oncologie Médicale - Hôpital Pitié-Salpêtrière
    - Contact:
      
      Jean-Philippe Spano, MD
    - Principal Investigator:
      
      Jean-Philippe Spano, MD
  - Paris, France, 75651
    - Recruiting
    - Service des Maladies Infectieuses et Tropicales - Hôpital Pitié-Salpêtrière
    - Contact:
      
      Christine KATLAMA, MD
    - Principal Investigator:
      
      Christine KATLAMA, MD
  - Paris, France, 75651
    - Recruiting
    - Service Hématologie Clinique - Hôpital Pitié-Salpêtrière
    - Contact:
      
      Sylvain Choquet
  - Paris, France, 75908
    - Recruiting
    - Service d'Immunologie Clinique - Hôpital européen Georges Pompidou
    - Contact:
      
      Laurence WEISS, MD
    - Principal Investigator:
      
      Laurence WEISS, MD
  - Paris, France, 75909
    - Recruiting
    - Service de Cancérologie Médicale - Hôpital européen Georges Pompidou
    - Contact:
      
      Stéphane OUDARD, MD
    - Principal Investigator:
      
      Stéphane OUDARD, MD
  - Paris, France, 75970
    - Recruiting
    - Service de pneumologie - Hôpital Tenon
    - Contact:
      
      Armelle LAVOLE, MD
    - Principal Investigator:
      
      Armelle LAVOLE, MD
  - Paris, France, 75971
    - Recruiting
    - Service des Maladies Infectieuses et Tropicales - Hôpital Tenon
  - Saint-Brieuc, France, 22000
    - Not yet recruiting
    - Service de pneumologie - Hôpital Yves Le Foll
    - Contact:
      
      Gwenaëlle LE GARFF, MD
    - Principal Investigator:
      
      Gwenaëlle LE GARFF, MD
  - Saint-Brieuc, France, 22000
    - Not yet recruiting
    - Service Médecine interne - Maladies Infectieuses - Hôpital Yves Le Foll
    - Contact:
      
      Corinne DANIEL, MD
    - Principal Investigator:
      
      Corinne DANIEL, MD
  - Saint-Brieuc, France, 22000
    - Not yet recruiting
    - Service Oncologie Hématologie - Hôpital Yves Le Foll
    - Contact:
      
      Corinne ALLEAUME, MD
    - Principal Investigator:
      
      Corinne ALLEAUME, MD
  - Saint-Priest-en-Jarez, France, 42270
    - Recruiting
    - Centre Hospitalier Universitaire de Saint Etienne
    - Contact:
      
      Anne FRESARD, MD
    - Principal Investigator:
      
      Anne FRESARD, MD
  - Saint-Priest-en-Jarez, France, 42270
    - Not yet recruiting
    - Institut de Cancérologie Lucien Neuwirth
    - Principal Investigator:
      
      Pierre Fournel, MD
    - Contact:
      
      Pierre FOURNEL, MD
  - Strasbourg, France, 67091
    - Not yet recruiting
    - Le Trait d'Union - Hôpitaux Universitaires de Strasbourg
    - Contact:
      
      Marie-Laure BATARD, MD
    - Principal Investigator:
      
      Marie-Laure BATARD, MD
  - Suresnes, France, 92151
    - Recruiting
    - Service de Médecine Interne - Hôpital Foch
    - Contact:
      
      David ZUCMAN, MD
    - Principal Investigator:
      
      David ZUCMAN, MD
  - Suresnes, France, 92151
    - Recruiting
    - Service de Pneumologie - Hôpital Foch
    - Contact:
      
      Jean-Louis COUDERC, MD
    - Principal Investigator:
      
      Jean-Louis COUDERC, MD
  - Toulon, France, 83041
    - Not yet recruiting
    - Service de Médecine Interne - Hôpital d'Instruction des Armées Saint Anne
    - Contact:
      
      Jean-Pierre DE JAUREGUIBERRY, MD
    - Principal Investigator:
      
      Jean-Pierre DE JAUREGUIBERRY, MD
  - Toulouse, France, 31059
    - Recruiting
    - Service des Maladies Infectieuses et Tropicales - Hôpital Purpan
    - Principal Investigator:
      
      Pierre DELOBEL, MD
    - Contact:
      
      Pierre DELOBEL, MD
  - Tourcoing, France, 59208
    - Recruiting
    - Service des Maladies Infectieuses et du Voyageur - Centre Hospitalier de Tourcoing
    - Contact:
      
      Faïza AJANA, MD
    - Principal Investigator:
      
      Faïza AJANA, MD
  - Villejuif, France, 94800
    - Not yet recruiting
    - Département d'Innovation Thérapeutique et d'Essais Précoces - Institut Gustave Roussy
    - Contact:
      
      Aurelien Marabelle, MD
    - Principal Investigator:
      
      Aurelien Marabelle, MD
- Saint-Denis
  - La Réunion, Saint-Denis, France, 97405
    - Not yet recruiting
    - Service d'Immunologie - Hôpital Felix Guyon
    - Contact:
      
      Catherine GAUD, MD
    - Principal Investigator:
      
      Catherine GAUD, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV Infected Patients with a Cancer treated by Immune-Checkpoint Inhibitors.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of clinical and biological adverse events occurring with ICPi treatment during the study period Time Frame: 4.5 years	4.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immuno-virological evolution Time Frame: between Month0 and Month24	HIV-RNA plasma viral load copies/mL	between Month0 and Month24
Immuno-virological evolution Time Frame: between Month0 and Month 24	CD4+ and CD8+ T cells counts /mm3 and %, CD4/CD8 ratio.	between Month0 and Month 24
Disease status Time Frame: at Month12 and at Month24	Overall response rate	at Month12 and at Month24
Progression-Free survival Time Frame: at Month6, Month12, Month18, Month24	Progression-Free survival rate	at Month6, Month12, Month18, Month24
For Physiopathological Substudy "OncoVIRIM" : Objective Response Rate (OPR) Time Frame: 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	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
For Physiopathological Substudy "OncoVIRIM" : Detailed Immunological and Virological Evolution Time Frame: 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.	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
For Physiopathological Substudy "OncoVIRIM" : Detailed Immunological and Virological Evolution Time Frame: 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	- 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.	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
For Physiopathological Substudy "OncoVIRIM" : Detailed Immunological and Virological Evolution Time Frame: 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.	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
For Physiopathological Substudy "OncoVIRIM" : Time Frame: between Month0 and Month24	Incidence of autoimmune complications and changes in antibodies repertoires of B cell in case of immunological adverse event	between Month0 and Month24
For Physiopathological Substudy "OncoVIRIM" : Gene sequencing Time Frame: Week0	Gene sequencing whose interest appears to be major in the responses / adverse effects of ICPi, especially MHC class I and II	Week0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Bicetre Hospital

Pitié-Salpêtrière Hospital

Investigators

Principal Investigator: Jean-Philippe SPANO, MD, PhD, GH Pitié-Salpêtrière-Charles Foix
Principal Investigator: Olivier LAMBOTTE, MD, PhD, CHU Bicêtre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2018

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

June 15, 2022

Study Registration Dates

First Submitted

September 21, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (Actual)

November 28, 2017

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

2017-A00699-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Clinical Trials on HIV Infected Patients With Cancer Treated by ICPi

Tianjin Medical University Cancer Institute and...
Shaanxi Provincial Cancer Hospital; Shanxi Bethune Hospital; The First Affiliated... and other collaborators

Not yet recruiting

A Study on Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients

Breast Cancer Patients Treated With T-DXd
Yeon Hee Park
Helsinn Healthcare SA

Enrolling by invitation

NEPA in Patients With HER2-positive or HER2-low Advanced Breast Cancer Treated With T-DXd (PRO-NEPA)

Patients With HER2-positive Advanced Breast Cancer Treated With T-DXd | Patients With HER2-low Advanced Breast Cancer Treated With T-DXd

South Korea
Hellenic Cooperative Oncology Group

Completed

Clinical Outcomes and Prognostic Biomarkers Exploration Between HER2 Low and HER2 Zero eBC Patients

HER2 Low and HER2 Zero Patients With Operable Breast Cancer Treated With Dds-CT

Greece
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Hallam University; Clinique Pasteur Toulouse

Recruiting

SpaceOAR Post-Market Registry Study (OASIS)

Prostate Cancer Patients Treated by Radiotherapy

France, United Kingdom
Assiut University

Not yet recruiting

Diagnostic Value of Tc-99mMDP Bone Scan in Assessment of Renal Functions in Cancer Patients Compared to Estimated Glomerular Filtration Rate.

Cancer Patients Treated by Nephrotoxic Chemotherapy
Tel-Aviv Sourasky Medical Center

Unknown

Effect of Radiation Therapy Among Head and Neck Cancer Patients on the Inner Ear Function

Head and Neck Cancer Patients Treated With Radiotherapy
Institut National de la Santé Et de la Recherche...
European Commission; Gustave Roussy, Cancer Campus, Grand Paris

Completed

Long Term Neurocognitive Effects of Low-dose Radiation in the Brain: Study of 150 Patients in the French Hemangioma Cohort (CogRad)

Patients Treated by Radiotherapy With < One Gy to the Brain

France
The First Affiliated Hospital with Nanjing Medical...

Not yet recruiting

QL1706 With Olaparib for Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination Deficiency (HRD)

Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination Deficiency

China
Assistance Publique - Hôpitaux de Paris

Not yet recruiting

Preclinical Development of a 3D Bili-MRI Reconstruction Tool and an Artificial Intelligence Algorithm to Assist Endoscopists in Performing Endoscopic Retrograde Cholangiopancreatography (ERCP) (MAAGIE)

Patients With Biliary Stricture Treated During ERCP With Available MRCP and Abdominal CT Scan

France
Hospices Civils de Lyon

Unknown

ASIA Study : French Register of Inflammatory Eye Disease (ASIA)

Patients Treated for Cancer by Immunotherapy

France

Clinical Trials on Blood sample

Institut Pasteur
Centre Terrritorial Hospitalier Gaston Bourret

Not yet recruiting

Characterizing the Host Response to Leptospirosis for Better Diagnosis and Prognosis - NIHFI (NIHFI)

Leptospirosis
First Affiliated Hospital of Zhejiang University

Recruiting

The Association of Microbiota Composition With cGVHD After Allo-HSCT

Complication | Hematologic Malignancy | Hematopoietic Stem Cell Transplantation | Chronic Graft-versus-host-disease

China
University Hospital, Bordeaux
Ministry for Health and Solidarity, France

Recruiting

Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia (BIOCAI)

Immune Thrombocytopenia | Autoimmune Hemolytic Anemia | Autoimmune Neutropenia

France
University Hospital, Tours

Completed

Evaluation of the Technical Feasibility of Testing ct DNA for Homologous Recombination Gene Variants in Metastatic Prostate Cancer. (PROMECI)

Metastatic Prostate Cancer | Circulating Tumor DNA

France
University Hospital, Bordeaux

Completed

Cohort Follow-up: Progression and Consequences of Chronic Kidney Disease. (NéphroTest)

Renal Function Disorder | Chronic Renal Diseases
Memorial Sloan Kettering Cancer Center

Active, not recruiting

Genetic Susceptibility to Lung Cancer in Never Smokers

Lung Cancer

United States
Medical University of Warsaw

Completed

Multiple Electrode Aggregometry to Assess Platelet Function in Patients Undergoing Hip Joint Alloplasty With and Without Bone Cement (APJAB)

Arthroplasty | Platelet Aggregation | Methylmethacrylate Embolism

Poland
Stanford University

Withdrawn

Clinical and Pathologic Studies in Neuroendocrine Tumors

Neuroendocrine Tumors | Carcinoid Tumor

United States
Masonic Cancer Center, University of Minnesota

Completed

Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy

Acute Myeloid Leukemia

United States
The First Affiliated Hospital of Soochow University

Recruiting

Alterations in Intestinal Microbiota, Metabolites, and Immune Cells in Allo-HSCT

Graft Vs Host Disease

China

ANRS CO24 OncoVIHAC (Onco VIH Anti Checkpoint) (OncoVIHAC)

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

Study Overview

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Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on HIV Infected Patients With Cancer Treated by ICPi

Clinical Trials on Blood sample

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