lung cancer
Conditions
Interventions
Trade Name: OPVIDO
Product Name: NIVOLUMAB
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: NIVOLUMAB
CAS Number: 946414-94-4
Current Sponsor code: BMS-936558
Other descriptive name: NI
Sponsors
CHU de Besançon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- Signed informed consent 2- Male or female patients, age = 18 years 3- Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other) 4- Advanced NSCLC cancer patient previously treated with a first line of combo chemotherapy plus anti-PD-1 or chemotherapy plus anti-PDL-1 combination 5- Measurable disease defined according to RECIST v1.1 guidelines (Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.) 6- Patients must have a mandatory treatment-free interval of at least 21 days following previous systemic anti-cancer treatments 7- Patients who have received previous systemic anticancer treatment and/or radiotherapy should have recovered from any treatment related toxicity, to a level of = grade 1 (according to National Cancer Institute [NCI] common terminology criteria for adverse events, version 5 (CTCAE v5) with the exception of Grade 2 alopecia 8- Performance status 0 or 1 on the ECOG scale 9- Females must be using highly effective contraceptive measures and have a negative pregnancy test prior to the start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening: •Post-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments. •Women under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution. •Women with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation. Male patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 5 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 5 months after discontinuing study treatment. 10- Affiliation to French social security or receiving such a regime. 11- Ability to comply with the study protocol, in the Investigator’s judgment. 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 74 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37
Exclusion criteria
Exclusion criteria: 1- Diagnosis of additional malignancy within 2 years prior to the inclusion with the exception of curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical or breast cancer 2- Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study 3- Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment 4- Patient under guardianship, curatorship or under the protection of justice 5- Uncontrolled pleural effusion, pericardial effusion, ascites or symptomatic fistula 6- Uncontrolled tumor-related pain: Symptomatic lesions amenable to palliative radiotherapy should be treated prior to randomization. Patients should be recovered from the effects of radiation. There is no required minimum recovery period 7- Known active central nervous system metastases and/or carcinomatous meningitis. Subject with previously treated brain metastases and with radiological and clinical stability are allowed. 8- Presence of EGFR mutation, ALK or ROS1 translocation 9- Uncontrolled brain metastases. Patients with controlled brain metastases after radiation therapy or with asymptomatic brain metastases may be included. 10- Inadequate organ functions: known cardiac failure of unstable coronaropathy, respiratory failure, or uncontrolled infection or another life-risk condition 11- Active or chronic hepatitis B or C and/or HIV positive (HIV 1/2 antibodies patients), or a known history of active Tuberculosis bacillus 12- Any immunosuppressive therapy (i.e. corticosteroids >10mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study therapy 13- Active autoimmune disease that has required a systemic treatment in past 2 years (i.e. corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin) is allowed 14- Active or history of autoimmune disease or immune deficiency, 15- Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study, 16- Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study, 17- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met: 18- Prior allogeneic bone marrow transplantation or prior solid organ transplantation 19- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins 20- Known hypersensitivity or allergy to Chinese hamster ovary cell products or any component of Nivolumab formulation 21- History of idiopathic or secondary pulmonary fibrosis (History of radiation pneumonitis in the radiation field fibrosis is permitted), or evidence of active pneumonitis requiring a systemic treatment with 28 days before the planned start of study therapy 22- Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study 23- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia 24- Treatment with therapeutic oral
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluer l’efficacité de la combinaison UCPVax plus Nivolumab comme seconde ligne de traitement des cancers du poumon non à petites cellules avancés.;Secondary Objective: 1.Evaluer le taux de réponses objectives à 6 mois selon les critères RECIST. 2.Evaluer la survie sans progression et le taux de réponses objectives selon les critères iRECIST dans le bras expérimental 3.Evaluer le taux de contrôle de la maladie (DCR) après 12 mois. 4.Evaluer les toxicités selon les critères du NCI-CTCAE version 5 à chaque visite 5.Evaluer la survie globale (SG): intervalle de temps entre la date de l’initiation du traitement et la date de décès quelle que soit la cause. 6.Evaluer l’immunogénicité de la combinaison évaluée par test ELISPOT-interféron-gamma dans le sang périphérique. 7.Evaluer la qualité de vie relative à la santé 8.Exploratoire: TMB, ctDNA, microbiote, angiogenèse tumorale, infiltrats immunitaires ;Primary end point(s): Progression-free survival (PFS) rate at 6 months. PFS is defined by the duration from the date of initiation of the treatment to the disease progression (RECIST) or death from any cause whichever occurs first, censoring cases without progression at the date of last disease assessment. ;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Objective Response Rate (ORR) at 6 months according to RECIST criteria. ORR is defined as the addition of complete response (CR) and partial response (PR) rates. 2. PFS and ORR according to iRECIST criteria in the experimental arm 3. Disease Control Rate (DCR) by 12 months defined as the percentage of patients who have achieved complete response, partial response and stable disease to the therapeutic intervention. 4. Safety will be evaluated according to NCI CTCAE v 4.03 at each visit 5. Overall survival (OS) is defined by the duration from the date of inclusion to death from any cause. 6. Assessment of Telomerase-specific T cell responses by IFN-? ELISPOT in peripheral blood. 7. Health-related quality of life (HRQoL) evaluated using EORTC QLQ-C30 and LC-13 modules specific to lung cancer 8. Exploratory: TMB, ctDNA, microbiote, tumor angiogenesis, immune infiltrates ;Timepoint(s) of evaluation of this end point: 6 months / 12 months | — |
Countries
France
Outcome results
None listed