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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):
ANRS, Emerging Infectious Diseases

Tracking Information
First Submitted Date September 21, 2017
First Posted Date November 28, 2017
Last Update Posted Date January 25, 2018
Actual Study Start Date January 17, 2018
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 21, 2017)
Incidence of clinical and biological adverse events occurring with ICPi treatment during the study period [ Time Frame: 4.5 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 21, 2017)
  • Immuno-virological evolution [ Time Frame: between Month0 and Month24 ]
    HIV-RNA plasma viral load copies/mL
  • Immuno-virological evolution [ Time Frame: between Month0 and Month 24 ]
    CD4+ and CD8+ T cells counts /mm3 and %, CD4/CD8 ratio.
  • Disease status [ Time Frame: at Month12 and at Month24 ]
    Overall response rate
  • Progression-Free survival [ Time Frame: at Month6, Month12, Month18, Month24 ]
    Progression-Free survival rate
  • 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
  • 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.
  • 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.
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ANRS CO24 OncoVIHAC (Onco VIH Anti Checkpoint)
Official Title A Multicenter Observational Cohort for HIV Infected Patients With a Cancer Treated by Immune-Checkpoint Inhibitors.
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

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]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Retention:   Samples With DNA
Description:

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.

Sampling Method Non-Probability Sample
Study Population HIV Infected Patients with a Cancer treated by Immune-Checkpoint Inhibitors.
Condition HIV Infected Patients With Cancer Treated by ICPi
Intervention 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 21, 2017)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 15, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03354936
Other Study ID Numbers 2017-A00699-44
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party ANRS, Emerging Infectious Diseases
Study Sponsor ANRS, Emerging Infectious Diseases
Collaborators
  • 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
PRS Account ANRS, Emerging Infectious Diseases
Verification Date January 2018