HIV Infected Patients With Cancer Treated by ICPiOncoVIHACNCT03354936
ANRS CO24 OncoVIHAC (Onco VIH Anti Checkpoint)
An observational study of HIV Infected Patients With Cancer Treated by ICPi, run by ANRS, Emerging Infectious Diseases at 56 sites in France.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infected Patients With Cancer Treated by ICPi
- What is being tested?
- Blood sample
- How many people
- 50 participants
- Where
- 56 sitesFrance
- Study dates
- 17 Jan 2018to 15 Jun 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV Infected Patients with a Cancer treated by Immune-Checkpoint Inhibitors.
Who may be able to join
- 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
- Participant included in the observatory
Show all 14Show fewer
- 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
Who cannot join
- Subject participating in clinical trials "CHIVA 2" (Lung Cancer- IFCT) and "HANOVRE" (Hodgkin's disease - LYSA)
- Study Population for the Physiopathological Substudy "OncoVIRIM":
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
France56 sites, 56 recruiting
- Recruiting
Service d'Hématologie Oncologie - Centre Hospitalier du Pays d'Aix
Aix-en-Provence, 13616
Thierry ALLEGRE, MD
Thierry ALLEGRE, MD
- Recruiting
Service de pneumologie - Hôpital Victor Dupouy
Argenteuil, 95100
Laure BELMONT, MD
Laure BELMONT, MD
- Not yet recruiting
Service d'Onco-Hématologie Immunodépression - Hôpital Henri Duffaut
Avignon, 84000
Gilles PICHANCOURT, MD
Gilles PICHANCOURT, MD
- Not yet recruiting
Service des Maladies Infectieuses et Tropicales - Hôpital Jean Minjoz
Besançon, 25030
Catherine CHIROUZE, MD
Catherine CHIROUZE, MD
- Not yet recruiting
Pôle de Médecine 2 - Centre Hospitalier Andrée Rosemon
Cayenne, 97306
Béatrice VIRJOGHE, MD
- Not yet recruiting
Service de Médecine interne - Hôpital Antoine Béclère
Clamart, 92141
Jean-François BOUE, MD
Jean-François BOUE, MD
- Not yet recruiting
Service d'hématologie - Hôpital Gabriel Montpied
Clermont-Ferrand, 63000
Cécile MOLUCON-CHABROT, MD
Cécile MOLUCON-CHABROT, MD
- Not yet recruiting
Service des Maladies Infectieuses et Tropicales - Hôpital Gabriel Montpied
Clermont-Ferrand, 63000
Christine JACOMET, MD
Christine JACOMET, MD
- Recruiting
Service d'Immunologie Clinique - Hôpital Henri Mondor
Créteil, 94010
Jean-Daniel LELIEVRE, MD
Jean-Daniel LELIEVRE, MD
- Not yet recruiting
Service de Médecine interne - Centre Hospitalier Intercommunal
Créteil, 94010
Valérie GARRAIT, MD
Valérie GARRAIT
- Not yet recruiting
Service de pneumologie - Centre Hospitalier Intercommunal
Créteil, 94010
Isabelle MONNET, MD
Isabelle MONNET, MD
- Recruiting
Service Hémopathies Lymphoïdes - Hôpital Henri Mondor
Créteil, 94010
Corinne HAIOUN, MD
Corinne HAIOUN, MD
- Not yet recruiting
Service Oncologie Médicale - Centre Hospitalier Intercommunal
Créteil, 94010
Isabelle COJEAN-ZELEK
Isabelle COJEAN-ZELEK, MD
- Not yet recruiting
Service d'Immunologie - Hôpital Felix Guyon
La Réunion, Saint-Denis, 97405
Catherine GAUD, MD
Catherine GAUD, MD
- Recruiting
Service de Médecine interne et Maladies infectieuses - Hôpital André Mignot
Le Chesnay, 78150
Alix GREDER-BELAN, MD
Alix GREDER-BELAN, MD
- Recruiting
Service d'hématologie et oncologie - Hôpital André Mignot
Le Chesnay, 78151
Caroline BESSON, MD
Caroline BESSON, MD
- Recruiting
Service de Médecine interne-Immunologie clinique - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94276
Olivier LAMBOTTE, MD
Olivier LAMBOTTE, MD
- Not yet recruiting
Service des Maladies Infectieuses et Tropicales - Hôpital de la Croix Rousse
Lyon, 69317
Laurent COTTE, MD
Laurent COTTE, MD
- Not yet recruiting
Ambulatoire-Hôpital de Jour - Institut Paoli Calmettes
Marseille, 13273
Jean-François MOULIN, MD
Jean-François MOULIN, MD
- Recruiting
Service d'hématologie-Cisih - Hôpital Sainte Marguerite
Marseille, 13274
Isabelle POIZOT-MARTIN, MD
Isabelle POIZOT-MARTIN, MD
- Recruiting
Service de dermatologie - Hôpital St Joseph
Marseille, 13285
Frank TOLLINCHI, MD
Frank TOLLINCHI, MD
- Recruiting
Service de Pneumologie - Hôpital St Joseph
Marseille, 13285
Christina AUDOLY, MD
Christina AUDOLY, MD
- Recruiting
Chirurgie Urologique et Tranplantation Rénale - Hôpital de la Conception
Marseille, 13385
Eric LECHEVALLIER, MD
Eric LECHEVALLIER, MD
- Recruiting
Service d'Oncologie médicale - Hôpital de la Timone
Marseille, 13385
Jean-Laurent DEVILLE, MD
Jean-Laurent DEVILLE, MD
- Recruiting
Service dermatologie/vénéréologie - Hôpital de la Timone
Marseille, 13385
Jean-Jacques GROB, MD
Jean-Jacques GROB, MD
- Recruiting
Service d'oncologie multidiscliplinaire - Hôpital Nord
Marseille, 13915
Laurent GREILLIER, MD
Laurent GREILLIER, MD
- Recruiting
Service de Médecine Interne - Centre Hospitalier de Martigues
Martigues, 13695
Rolande COHEN VALENSI, MD
Rolande COHEN VALENSI, MD
- Recruiting
Service des Maladies Infectieuses et Tropicales - Hôpital Gui de Chauliac
Montpellier, 34295
Alain MAKINSON, MD
Alain MAKINSON, MD
- Recruiting
Service de Dermatologie - Hôpital l'Archet
Nice, 06202
Alexandra PICARD, MD
Alexandra PICARD, MD
- Recruiting
Service de médecine interne Cancérologie - Hôpital l'Archet
Nice, 06202
Eric ROSENTHAL, MD
Eric ROSENTHAL, MD
- Recruiting
Service des Maladies Infectieuses et Tropicales - Hôpital l'Archet
Nice, 06202
Alissa NAQVI, MD
Alissa NAQVI, MD
- Recruiting
Service des Maladies Infectieuses - Hôpital Saint Antoine
Paris, 75012
Karine LACOMBE, MD
Karine LACOMBE, MD
- Recruiting
Service Infectiologie - Hôpital de l'Hôtel-Dieu
Paris, 75101
Dominique SALMON-CERON, MD
Dominique SALMON-CERON, MD
- Recruiting
Service d'immuno-pathologie clinique - Hôpital Saint-Louis
Paris, 75475
Laurence GERARD, MD
Laurence GERARD, MD
- Recruiting
Service des Maladies Infectieuses - Hôpital Saint-Louis
Paris, 75475
Diane PONSCARME, MD
Diane PONSCARME, MD
- Not yet recruiting
Servide de Dermatologie - Hôpital Saint-Louis
Paris, 75475
Céleste LEBBE, MD
Céleste LEBBE, MD
- Recruiting
Service d'Oncologie Médicale - Hôpital Pitié-Salpêtrière
Paris, 75651
Jean-Philippe SPANO, MD
Jean-Philippe Spano, MD
- Recruiting
Service des Maladies Infectieuses et Tropicales - Hôpital Pitié-Salpêtrière
Paris, 75651
Christine KATLAMA, MD
Christine KATLAMA, MD
- Recruiting
Service Hématologie Clinique - Hôpital Pitié-Salpêtrière
Paris, 75651
Sylvain CHOQUET
Sylvain CHOQUET, MD
- Recruiting
Hôpital Bichat
Paris, 75877
Yazdan YAZDANPANAH, MD
Yazdan YAZDANPANAH, MD
- Recruiting
Service d'Immunologie Clinique - Hôpital européen Georges Pompidou
Paris, 75908
Laurence WEISS, MD
Laurence WEISS, MD
- Recruiting
Service de Cancérologie Médicale - Hôpital européen Georges Pompidou
Paris, 75909
Stéphane OUDARD, MD
Stéphane OUDARD, MD
- Recruiting
Service de pneumologie - Hôpital Tenon
Paris, 75970
Armelle LAVOLE, MD
Armelle LAVOLE, MD
- Recruiting
Service des Maladies Infectieuses et Tropicales - Hôpital Tenon
Paris, 75971
Gilles PIALOUX, MD
Gilles PIALOUX, MD
- Not yet recruiting
Service de pneumologie - Hôpital Yves Le Foll
Saint-Brieuc, 22000
Gwenaëlle LE GARFF, MD
Gwenaëlle LE GARFF, MD
- Not yet recruiting
Service Médecine interne - Maladies Infectieuses - Hôpital Yves Le Foll
Saint-Brieuc, 22000
Corinne DANIEL, MD
Corinne DANIEL, MD
- Not yet recruiting
Service Oncologie Hématologie - Hôpital Yves Le Foll
Saint-Brieuc, 22000
Corinne ALLEAUME, MD
Corinne ALLEAUME, MD
- Recruiting
Centre Hospitalier Universitaire de Saint Etienne
Saint-Priest-en-Jarez, 42270
Anne FRESARD, MD
Anne FRESARD, MD
- Not yet recruiting
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
Pierre FOURNEL, MD
Pierre FOURNEL, MD
- Not yet recruiting
Le Trait d'Union - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Marie-Laure BATARD, MD
Marie-Laure BATARD, MD
- Recruiting
Service de Médecine Interne - Hôpital Foch
Suresnes, 92151
David ZUCMAN, MD
David ZUCMAN, MD
- Recruiting
Service de Pneumologie - Hôpital Foch
Suresnes, 92151
Jean-Louis COUDERC, MD
Jean-Louis COUDERC, MD
- Not yet recruiting
Service de Médecine Interne - Hôpital d'Instruction des Armées Saint Anne
Toulon, 83041
Jean-Pierre DE JAUREGUIBERRY, MD
Jean-Pierre DE JAUREGUIBERRY, MD
- Recruiting
Service des Maladies Infectieuses et Tropicales - Hôpital Purpan
Toulouse, 31059
Pierre DELOBEL, MD
Pierre DELOBEL, MD
- Recruiting
Service des Maladies Infectieuses et du Voyageur - Centre Hospitalier de Tourcoing
Tourcoing, 59208
Faïza AJANA, MD
Faïza AJANA, MD
- Not yet recruiting
Département d'Innovation Thérapeutique et d'Essais Précoces - Institut Gustave Roussy
Villejuif, 94800
Aurélien MARABELLE, MD
Aurélien MARABELLE, MD
About this study
Official title: 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.
Read more
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
Read the 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
- Being tested
- Blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinical and biological adverse events occurring with ICPi treatment during the study period
Measured: 4.5 years
Secondary outcomes (10)
Immuno-virological evolution
HIV-RNA plasma viral load copies/mL
Measured: between Month0 and Month24
Immuno-virological evolution
CD4+ and CD8+ T cells counts /mm3 and %, CD4/CD8 ratio.
Measured: between Month0 and Month 24
Disease status
Overall response rate
Measured: at Month12 and at Month24
Progression-Free survival
Progression-Free survival rate
Measured: at Month6, Month12, Month18, Month24
For Physiopathological Substudy "OncoVIRIM" : Objective Response Rate (OPR)
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
Measured: 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
- 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.
Measured: 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
- 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.
Measured: 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
- 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.
Measured: 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" :
Incidence of autoimmune complications and changes in antibodies repertoires of B cell in case of immunological adverse event
Measured: between Month0 and Month24
For Physiopathological Substudy "OncoVIRIM" : Gene sequencing
Gene sequencing whose interest appears to be major in the responses / adverse effects of ICPi, especially MHC class I and II
Measured: Week0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start17 Jan 2018
- Primary completion1 Jan 2022 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Infected Patients With Cancer Treated by ICPiStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Pitié-Salpêtrière Hospital, Bicetre Hospital
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe SPANO, MD, PhD, Principal investigator, GH Pitié-Salpêtrière-Charles FoixOlivier LAMBOTTE, MD, PhD, Principal investigator, CHU Bicêtre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354936
- Sponsor's protocol ID
- 2017-A00699-44
- Acronym
- OncoVIHAC
- Status last verified
- Jan 2018
- First submitted
- 21 Sep 2017
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Observational Cohort for HIV Infected Patients With a Cancer Treated by Immune-Checkpoint Inhibitors.
- ClinicalTrials.gov ID
- NCT03354936
- Acronym / sponsor ID
- OncoVIHAC / 2017-A00699-44
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Pitié-Salpêtrière Hospital, Bicetre Hospital
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV Infected Patients with a Cancer treated by Immune-Checkpoint Inhibitors.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (2 listed)
- Subject participating in clinical trials "CHIVA 2" (Lung Cancer- IFCT) and "HANOVRE" (Hodgkin's disease - LYSA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBlood 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 | Biological | – |
Primary outcome
Incidence of clinical and biological adverse events occurring with ICPi treatment during the study period
Time frame: 4.5 years
10 secondary outcomes
Immuno-virological evolution
Time frame: between Month0 and Month24
Immuno-virological evolution
Time frame: between Month0 and Month 24
Disease status
Time frame: at Month12 and at Month24
Progression-Free survival
Time frame: 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
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
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
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
For Physiopathological Substudy "OncoVIRIM" :
Time frame: between Month0 and Month24
For Physiopathological Substudy "OncoVIRIM" : Gene sequencing
Time frame: Week0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe SPANO, MD, PhD principal investigator
GH Pitié-Salpêtrière-Charles Foix
Olivier LAMBOTTE, MD, PhD principal investigator
CHU Bicêtre
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infected Patients With Cancer Treated by ICPi, run by ANRS, Emerging Infectious Diseases at 56 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joséphine Anna TINE (+33 (0)1 42 16 42 88, josephine-anna.tine@iplesp.upmc.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinical and biological adverse events occurring with ICPi treatment during the study period (time frame: 4.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.