Immunotherapy by Nivolumab for HIV+ Patients

Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Study ID
NCT03304093
Phase
PHASE2
Status
Completed

Conditions

  • HIV/AIDS
  • Non Small Cell Lung Cancer Metastatic
  • Non Small Cell Lung Cancer Stage IIIB

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Two Phase III trials showed superiority in terms of efficacy and tolerance of nivolumab in second-line treatment compared to docetaxel in metastatic NSCLC in the general population, so it is important to evaluate this treatment in PLWHIV (Patient Living With HIV) in maximum security conditions, taking into account their specificities and complex underlying immunological status. As NSCLC in PLWHIV is a rare tumour, a phase 2 trial, using DCR (Disease Control Rate) data, would be able to recruit a sufficient number of patients, in a reasonable period of time, to provide a proof of concept of the safety and efficacy of nivolumab in this population. Therefore, we think that an open-label, one arm phase 2 trial, with a rapid accrual, would be currently a crucial approach and a window of opportunity to explore whether nivolumab could find its place in PLWHIV with NSCLC. Such a trial is typically a trial for an academic sponsor, experienced in PLWHIV with NSCLC, which previously showed its ability to recruit patients with such a rare disease as the IFCT did with the IFCT-1001 CHIVA trial, testing carboplatin plus pemetrexed followed by pemetrexed.

Key Dates

Start date
Oct 19, 2017
Status verified
Mar 2023
Primary completion
Feb 18, 2021
Completion
Feb 18, 2022

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Nivolumab 3mg/kg every 2 weeks

Primary Outcome Measure

Disease Control Rate [ Time Frame: 8 weeks ]

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