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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Nivolumab 3mg/kg every 2 weeks
CH d'Avignon
Avignon, France
CH de la Côte Basque
Bayonne, France
CH Cahors
Cahors, France
CH
Colmar, France
CHI Créteil
Créteil, France
Centre Hospitalier - Pneumologie
Le Mans, France
Hôpital de la Croix Rousse
Lyon, France
AP-HM Hôpital Nord
Marseille, France
Montpellier - CHRU
Montpellier, France
Montpellier - ICM
Montpellier, France
...and 8 more locations
Disease Control Rate
Time frame: 8 weeks
Progression Free Survival
Time between the date of inclusion and the first date of documented progression or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death. Subjects who did not progress or die will be censored on the date of their last evaluable tumor assessment.
Time frame: 6 months and one year
Overall Survival
Time elapsed between the date of inclusion and death. Subjects who did not die will be censored on the last date a subject was known to be alive.
Time frame: 6 months and one year
Tolerance
Adverse Events (AEs) grade (NCI-CTC 4.0)
Time frame: 8 weeks, 6 months and one year
Responses rate according to tissue PD-L1 expression
Time frame: 8 weeks
Quality of life measured by LCSS questionnaire
Time frame: After 2, 3, 5, 7 and 9 cycles (each cycle is 14 days)
Duration of response
Time frame: 8 weeks, 6 months and one year
impact on HIV control and immunological, other associated chronic infection susceptible of reactivation and potential occurrence of autoimmunity
Time frame: 8 weeks, 6 months and one year
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