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Immunotherapy by Nivolumab for HIV+ Patients

NCT03304093 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-05-12

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Nivolumab Injection

Nivolumab 3mg/kg every 2 weeks

Sponsors & Collaborators

  • ANRS, Emerging Infectious Diseases

    collaborator OTHER_GOV

  • Intergroupe Francophone de Cancerologie Thoracique

    lead OTHER

Principal Investigators

  • Armelle LAVOLE, MD · APHP Hôpital Tenon

  • Jacques CADRANEL, MD, PhD · APHP Hôpital Tenon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-19
Primary Completion
2021-02-18
Completion
2022-02-18

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03304093 on ClinicalTrials.gov