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Non Small Cell Lung Cancer MetastaticPhase 2CHIVA2NCT03304093

Immunotherapy by Nivolumab for HIV+ Patients

A Phase 2 study testing Nivolumab Injection in people with Non Small Cell Lung Cancer Metastatic and Non Small Cell Lung Cancer Stage IIIB, run by Intergroupe Francophone de Cancerologie Thoracique at 18 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
18 sitesFrance
Study dates
19 Oct 2017to 18 Feb 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old
  • HIV1 or HIV2, regardless of CD4 cell count
  • HIV Viral load <200 copies/mL
  • Proven histologically and/or cytologically, stage IIIB-IV or metastatic relapse post-surgery non-small cell lung cancer (NSCLC)
  • Disease recurrence or progression during/after at least one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease
  • Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per RECIST 1.1 criteria
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  • Performance status (PS) 0, 1 or 2
  • Written informed consent
  • Patients must have adequate organ function: creatinine clearance > 40 mL/min (Cockcroft, MDRD or CKD-Epi formula or 24h Urine Calculate creatinine clearance from a 24h urine collection ), neutrophiles count > 1500/mm3; platelets > 100 000/mm3 ; hemoglobin > 9 g/dL; hepatic enzymes < 3N with total bilirubin ≤ 1.5 × ULN (upper limit of normal) except subjects with documented Gilbert's syndrome (≤ 5 × ULN) or liver metastasis, who must have a baseline total bilirubin ≤ 3.0 mg/dL
  • Patients must receive appropriate care and treatment for HIV infection including ART when clinically indicated and subjects should be under the care of a physician experienced in HIV management. In case of recent introduction of cART and CD4 levels <50 cells/ml, inclusion will be possible provided subjects had at least 4 weeks of treatment prior to inclusion, to avoid clinical type IRIS (immune inflammatory syndrome reconstitution). All antiretroviral treatments are allowed.
  • Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of contraception after this point should be discussed with the referent physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. They must also refrain from egg cell donation for 6 months after the final dose of investigational product. Men receiving nivolumab and who are sexually active with women of childbearing potential will be instructed to adhere to contraception (appendix I) for a period of 31 weeks after the last dose of nivolumab.
  • Persons deprived of liberty could be eligible because the expected benefice (improvement of disease control rate) justifies the foreseeable risk (adverse reaction of nivolumab).

Who cannot join

  • Concurrent malignancies requiring active intervention
  • Active Infection
  • Patient with known EGFR activating tumor mutation or known ALK or ROS1 gene rearrangement not treated with the appropriate targeted therapy.
  • History of immunological events related to HIV: lymphoid interstitial pneumonitis (LIP), non-infectious uveitis, encephalitis and other manifestations of CD8 lymphocyte infiltration syndrome, HIV-associated nephropathy (HIVAN).
  • Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Active or history of inflammatory bowel disease (eg, diverticulitis, colitis, Crohn's, coeliac disease or other serious gastrointestinal chronic conditions associated with diarrhea). Note that diverticulosis is permitted.
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  • Symptomatic cerebral metastasis unless treated by brain radiotherapy which will be completed for at least 15 days before the beginning of the treatment; subjects with carcinomatous meningitis.
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • The last dose of prior chemotherapy or radiation therapy (with the exception of palliative radiotherapy) was received less than 3 weeks prior to inclusion;
  • History of primary immunodeficiency, history of organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of inclusion or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of inclusion. Intranasal/inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control.
  • Legally protected adults.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • CH d'Avignon

    Avignon

  • CH de la Côte Basque

    Bayonne

  • CH Cahors

    Cahors

  • CH

    Colmar

  • CHI Créteil

    Créteil

  • Centre Hospitalier - Pneumologie

    Le Mans, 72000

  • Hôpital de la Croix Rousse

    Lyon

  • AP-HM Hôpital Nord

    Marseille

  • Montpellier - CHRU

    Montpellier, 34295

  • Montpellier - ICM

    Montpellier

  • APHP - Hopital Tenon - Pneumologie

    Paris, 75020

  • Paris - APHP Bichat

    Paris

  • Paris - Pitié-salpêtrière

    Paris

  • CH de Pau

    Pau

  • Saint Brieuc - CHG

    Saint-Brieuc, 22000

  • NHC - Pneumologie

    Strasbourg, 63000

  • Suresnes - Hopital Foch

    Suresnes, 92151

  • CHU Toulouse - Pneumologie

    Toulouse

Other trials in France

About this study

Official title: Immunotherapy by Nivolumab After Prior Chemotherapy for HIV+ Patients With Advanced Non-small Cell Lung Cancer (NSCLC): IFCT-CHIVA2 Phase IIa Trial

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.

Being tested
Nivolumab Injection
Keywords
IFCT, VIH, Nivolumab, NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nivolumab InjectionDrug

    Nivolumab 3mg/kg every 2 weeks

Study groups in NCT03304093
Study groupRoleWhat they receive
NivolumabExperimentalNivolumab 3mg/kg every 2 weeks
Receives: Drug: Nivolumab Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Control Rate

    Measured: 8 weeks

Secondary outcomes (7)

  1. 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.

    Measured: 6 months and one year

  2. 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.

    Measured: 6 months and one year

  3. Tolerance

    Adverse Events (AEs) grade (NCI-CTC 4.0)

    Measured: 8 weeks, 6 months and one year

  4. Responses rate according to tissue PD-L1 expression

    Measured: 8 weeks

  5. Quality of life measured by LCSS questionnaire

    Measured: After 2, 3, 5, 7 and 9 cycles (each cycle is 14 days)

  6. Duration of response

    Measured: 8 weeks, 6 months and one year

  7. impact on HIV control and immunological, other associated chronic infection susceptible of reactivation and potential occurrence of autoimmunity

    Measured: 8 weeks, 6 months and one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2017
  2. Study start19 Oct 2017
  3. Primary completion18 Feb 2021
  4. Study completion18 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03304093
Sponsor's protocol ID
IFCT-1602
Acronym
CHIVA2
Status last verified
Mar 2023
First submitted
19 Sep 2017
Last updated
12 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab Injection in people with Non Small Cell Lung Cancer Metastatic and Non Small Cell Lung Cancer Stage IIIB, run by Intergroupe Francophone de Cancerologie Thoracique at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control Rate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03304093.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.

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