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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
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
  • 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

    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

    Not yet recruiting
  • Service d'Immunologie Clinique - Hôpital Henri Mondor

    Créteil, 94010

    Jean-Daniel LELIEVRE, MD

    Jean-Daniel LELIEVRE, MD

    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

    Not yet recruiting
  • Service Hémopathies Lymphoïdes - Hôpital Henri Mondor

    Créteil, 94010

    Corinne HAIOUN, MD

    Corinne HAIOUN, MD

    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

    Not yet 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

    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

    Not yet 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

    Recruiting
  • Servide de Dermatologie - Hôpital Saint-Louis

    Paris, 75475

    Céleste LEBBE, MD

    Céleste LEBBE, MD

    Not yet 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

    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

    Not yet recruiting
  • Centre Hospitalier Universitaire de Saint Etienne

    Saint-Priest-en-Jarez, 42270

    Anne FRESARD, MD

    Anne FRESARD, MD

    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

    Not yet 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

    Recruiting
  • Service de Médecine Interne - Hôpital d'Instruction des Armées Saint Anne

    Toulon, 83041

    Jean-Pierre DE JAUREGUIBERRY, MD

    Jean-Pierre DE JAUREGUIBERRY, MD

    Not yet 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

    Recruiting
  • Département d'Innovation Thérapeutique et d'Essais Précoces - Institut Gustave Roussy

    Villejuif, 94800

    Aurélien MARABELLE, MD

    Aurélien MARABELLE, MD

    Not yet recruiting

Other trials in France

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.

  1. Incidence of clinical and biological adverse events occurring with ICPi treatment during the study period

    Measured: 4.5 years

Secondary outcomes (10)
  1. Immuno-virological evolution

    HIV-RNA plasma viral load copies/mL

    Measured: between Month0 and Month24

  2. Immuno-virological evolution

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

    Measured: between Month0 and Month 24

  3. Disease status

    Overall response rate

    Measured: at Month12 and at Month24

  4. Progression-Free survival

    Progression-Free survival rate

    Measured: at Month6, Month12, Month18, Month24

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  1. First posted28 Nov 2017
  2. Study start17 Jan 2018
  3. Primary completion1 Jan 2022 (estimated)
  4. Study completion15 Jun 2022 (estimated)

Resources

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
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

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.

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