Metastatic Non-Small Cell Lung Cancer (NSCLC) and Renal Cell Carcinoma (RCC) MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: LLT Classification code 10038395 Term: Renal carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
EverImmune SAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed Stage IV NSCLC or clear cell RCC. 2. Patient eligible for SOC PD-L1 based immunotherapy or chemo-immunotherapy (for NSCLC) and ipilimumab + nivolumab (for RCC). 3. NSCLC cohort-specific criterion: best tumor response (by iRECIST) as stable disease (SD) between 12 and 18 weeks after initiation of first line PD-L1-based –immunotherapy or chemo-immunotherapy. 4. RCC cohort-specific criterion: intermediate- or poor-risk35 newly diagnosed RCC patients (clear cell histology). 5. Negative stool polymerase chain reaction (PCR) test for Akkermansia (A. muciniphila and A. massiliensis) as defined in paragraph 11.2.7.2. of the protocol. 6. NSCLC Cohort-specific criterion: PD-L1 expression data =1%. 7. At least one measurable (target) lesion per iRECIST. 8. Eastern Cooperative Oncology Group (ECOG) performance status = 0-1. 9. Age >18 years. 10. Hemoglobin =90 g/L. 11. Neutrophil count =1.0 x 109/L. 12. Platelet count =75 x 109/L. 13. Lymphocyte count > 0.5 x 10e9/L. 14. Albumin >30 g/L. 15. A wash-out period of 5 half-lives or more since the last dose administered of any investigational medicinal products or chemotherapy received previously. 16. For patients of child-bearing potential, commitment to use a birth control method with a failure rate of less than 1% per year, during the entire treatment period AND for at least 4 months after the last dose of ICI (for NSCLC patients) OR at least 5 months after the last dose of nivolumab (for RCC patients). 17. Signed informed consent form. 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 128 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Symptomatic brain metastases. Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period. 2. Alanine aminotransferase (ALT) >5 times the upper limit of normal range (ULN). 3. Calculated creatinine clearance 10 mg prednisone/day equivalent) within 4 weeks of signed informed consent. 6. Known allergy to Oncobax®-AK excipients. 7. Radiotherapy (>30 Gy) to the lung(s) within 6 months of signed informed consent. 8. Active infection. A 4-week delay must have elapsed between the resolution of any systemic infection and the initiation of Oncobax®-AK administration. 9.Vaccination with a live attenuated virus, other than influenza, within 6 months of signed informed consent. 10. Pregnancy or breast-feeding. 11. Active inflammatory bowel disease and/or any medical condition that alters the integrity of the intestinal barrier. 12. Other co-morbidities that, in the opinion of the Investigator, may place the patient at a higher risk of treatment-related AEs. 13. Inability to comply with protocol-specific assessments. 14. Patient is subject to any of the following procedures: ward of court, trusteeship, supervision order, applied mandate of future protection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1: Characterize the safety profile and tolerability of repeated doses of Oncobax®-AK administered in combination with PD-L1-based chemo-immunotherapy in metastatic NSCLC or RCC patients deficient in Akkermansia. Phase 2: Characterize the efficacy of repeated doses of Oncobax®-AK administered in combination with PD-L1-based immunotherapy in metastatic NSCLC or RCC patients and deficient in Akkermansia.;Secondary Objective: Phase 2: Characterize the: - efficacy of repeated doses of Oncobax®-AK administered in combination with PD-L1-based immunotherapy in metastatic NSCLC or RCC patients - safety profile and tolerability of repeated doses of Oncobax®-AK administered in combination with PD-L1-based immunotherapy in metastatic NSCLC or RCC patients;Primary end point(s): Phase 1: - AEs, TEAEs, related TEAEs, SAEs, DLTs per NCI-CTCAE version 5.0 - Dose reductions and interruptions Phase 2: - ORR per iRECIST ;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase 2: - PFS9, OS12, DOR - AEs, TEAEs, related, TEAEs, SAEs, DLTs per NCI-CTCAE version 5.0 - Dose reductions and interruptions ;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Countries
Belgium, France
Contacts
Public ContactAlain Thibault
EverImmune SAS
Outcome results
None listed