Immunotherapy for HIV+ patients with Advanced lung cancer
- Conditions
- Advanced non small cell lung cancer in VIH+ patientMedDRA version: 20.0Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-003796-22-FR
- Lead Sponsor
- IFCT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
1.Age = 18 years old
2.HIV1 or HIV2, regardless of CD4 cell count
3.HIV Viral load <200 copies/mL
4.Proven histologically and/or cytologically, stage IIIB-IV or metastatic relapse post-surgery non-small cell lung cancer (NSCLC)
5.Disease recurrence or progression during/after at least one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease
6.Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per RECIST 1.1 criteria
7.Performance status (PS) 0, 1 or 2
8.Written informed consent
9.Patients must have adequate organ function: creatinine clearance > 40 mL/min (Cockroft, MDRD or CKD-Epi formula or 24h Urine Calculate creatinine clearance from a 24h urine collection ), neutrophiles count > 1500/mm3; platelets > 100 000/mm3 ; hemoglobine > 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
10.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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
1.Concurrent malignancies requiring active intervention
2.Active Infection
3.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).
4.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.
5.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.
6.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.
7.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.
8.The last dose of prior chemotherapy or radiation therapy (with the exception of palliative radiotherapy) was received less than 3 weeks prior to randomization;
9.History of primary immunodeficiency, history of organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.
10.Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Intranasal/inhaled or topical steroids, and adrenal replacement steroid doses = 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy of the anti-PD1 antibody (nivolumab) as measured by DCR.;Secondary Objective: •tolerance: Adverse Events (AEs) grade (NCI-CTC 4.0),<br>•impact on HIV control and immunological (CD4, CD8, HIV viral load each evaluation), other associated chronic infection susceptible of reactivation (HHV8, CMV, EBV, tuberculosis) and potential occurrence of autoimmunity (organ specific i.e. thyroiditis, adrenalitis and hypophysitis, or non organ specific) <br>•duration of response<br>•Reponses rate according to tissue PD-L1 expression <br>•progression-free survival<br>•Overall survival<br>•Quality of life (LCSS);Primary end point(s): Disease control rate;Timepoint(s) of evaluation of this end point: 8 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •tolerance: Adverse Events (AEs) grade (NCI-CTC 4.0),<br>•impact on HIV control and immunological (CD4, CD8, HIV viral load each evaluation), other associated chronic infection susceptible of reactivation (HHV8, CMV, EBV, tuberculosis) and potential occurrence of autoimmunity (organ specific i.e. thyroiditis, adrenalitis and hypophysitis, or non organ specific) <br>•duration of response<br>•Reponses rate according to tissue PD-L1 expression <br>•progression-free survival<br>•Overall survival<br>•Quality of life (LCSS)<br>;Timepoint(s) of evaluation of this end point: During all the study