Advanced non small cell lung cancer in VIH+ patient MedDRA version: 20.0 Level: PT Classification code 10041068 Term: Small cell lung cancer extensive stage System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Opdivo
Product Name: Opdivo
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Nivolumab
Other descriptive name: NIVOLUMAB
Concentration unit: mg/kg milligram(
Sponsors
IFCT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old 2. HIV1 or HIV2, regardless of CD4 cell count 3. HIV Viral load 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 =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of the anti-PD1 antibody (nivolumab) as measured by DCR.;Secondary Objective: • tolerance: Adverse Events (AEs) grade (NCI-CTC 4.0), • 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) • duration of response • Reponses rate according to tissue PD-L1 expression • progression-free survival • Overall survival • Quality of life (LCSS);Primary end point(s): Disease control rate;Timepoint(s) of evaluation of this end point: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • tolerance: Adverse Events (AEs) grade (NCI-CTC 4.0), • 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) • duration of response • Reponses rate according to tissue PD-L1 expression • progression-free survival • Overall survival • Quality of life (LCSS) ;Timepoint(s) of evaluation of this end point: During all the study | — |
Countries
France
Contacts
Public ContactContact
IFCT
Outcome results
None listed