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

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ClinicalTrials.gov Identifier: NCT03354936
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : January 25, 2018
Sponsor:
Collaborators:
Pitié-Salpêtrière Hospital
Bicetre Hospital
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Brief Summary:

A Multicenter, Observational, National Cohort for HIV Infected Patients with a Cancer treated by Immune-Checkpoint Inhibitors (ICPi) for less than one month or to be treated with an ICPi such as anti-PD-1 or anti-PDL-1 or anti-CTLA4, monitored in some French hospitals .

The objective of the study is to assess the safety of these new agents in HIV-infected patients.

As an observatory, the number of participants planned is not predetermined: the aim is to include for 2 years any participant infected with HIV and having a cancer treated by ICPi in one of the centers that have agreed to participate.

50 participants will be recruited for Substudy "OncoVIRIM" during the study period (regardless of tumor type or ICPi type); 8 or 9 time points (blood samples) will be scheduled

The cohort " ANRS CO24 OncoVIHAC " is declared to authorities like category 2 research .

No intervention in the observatory, a collection of data will be carried out in M0, M6, M12, M18 and M24.

For the physiopathological Substudy OncoVIRIM : Blood samples will be collected to constitute cell bank, plasma bank, serum bank, DNA bank in order to meet the objectives of this substudy and possibly for complementary research


Condition or disease Intervention/treatment
HIV Infected Patients With Cancer Treated by ICPi 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 [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: A Multicenter Observational Cohort for HIV Infected Patients With a Cancer Treated by Immune-Checkpoint Inhibitors.
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : June 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


Intervention Details:
  • Biological: Blood sample
    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 Outcome Measures :
  1. Incidence of clinical and biological adverse events occurring with ICPi treatment during the study period [ Time Frame: 4.5 years ]

Secondary Outcome Measures :
  1. Immuno-virological evolution [ Time Frame: between Month0 and Month24 ]
    HIV-RNA plasma viral load copies/mL

  2. Immuno-virological evolution [ Time Frame: between Month0 and Month 24 ]
    CD4+ and CD8+ T cells counts /mm3 and %, CD4/CD8 ratio.

  3. Disease status [ Time Frame: at Month12 and at Month24 ]
    Overall response rate

  4. Progression-Free survival [ Time Frame: at Month6, Month12, Month18, Month24 ]
    Progression-Free survival rate

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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


Biospecimen Retention:   Samples With DNA

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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV Infected Patients with a Cancer treated by Immune-Checkpoint Inhibitors.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354936


Contacts
Contact: Joséphine Anna TINE +33 (0)1 42 16 42 88 josephine-anna.tine@iplesp.upmc.fr
Contact: Safa LASSOUED +33 (0)1 42 16 42 88 safa.lassoued@iplesp.upmc.fr

  Show 56 Study Locations
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Pitié-Salpêtrière Hospital
Bicetre Hospital
Investigators
Principal Investigator: Jean-Philippe SPANO, MD, PhD GH Pitié-Salpêtrière-Charles Foix
Principal Investigator: Olivier LAMBOTTE, MD, PhD CHU Bicêtre

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT03354936     History of Changes
Other Study ID Numbers: 2017-A00699-44
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No