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: - Histologically or cytologically confirmed Stage IV non-squamous NSCLC or clear cell RCC. - NSCLC cohort-specific criterion: best tumor response (by iRECIST) as stable disease (SD) or progressive disease (PD), 12 weeks after initiation of first line PD-L1-based-immunotherapy. - RCC cohort-specific criterion: intermediate- or poor-risk newly diagnosed RCC patients (clear cell histology). - Negative stool polymerase chain reaction (PCR) test for Akkermansia (A. muciniphila and SGB9228). - NSCLC Cohort-specific criterion: PD-L1 expression data =50%. - At least one measurable (target) lesion per iRECIST. - Eastern Cooperative Oncology Group (ECOG) performance status = 0-1. - Age >18 years. - Hemoglobin =100 g/L. - Albumin >35 g/L. - 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 122 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Administration of antibiotics within 4 weeks of signed informed consent. - Symptomatic brain metastases. - Alanine aminotransferase (ALT) >5 times the upper limit of normal range (ULN). - Calculated creatinine clearance 10 mg prednisone/day equivalent) within 4 weeks of signed informed consent. - Known allergy to Oncobax®-AK excipients. - Radiotherapy (>30 Gy) to the lung(s) within 6 months of signed informed consent. - Active infection. - Pregnant or breast-feeding women. - Co-morbidities that, in the opinion of the Investigator, may place the patient at a higher risk of treatment-related AEs - Inability to comply with protocol-specific assessments.
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 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 1: Characterize the: - presence of Akk. p2261 in the gastrointestinal tract of patients following Oncobax®-AK administration - impact of Oncobax®-AK administration on the patients’ gastrointestinal microbiota composition - immuno-modulatory effects of Oncobax®-AK administration - changes in patients’ intestinal barrier fitness. 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 - presence of Akk. p2261in the gastrointestinal tract of patients following Oncobax®-AK administration - impact of Oncobax®-AK administration on the patients’ gastrointestinal microbiota composition - immuno-modulatory effects of Oncobax®-AK administration - changes in the patient’s intestinal barrier fitness;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 1: - Detection and duration of Akkermansia p2261 colonization in stools - Microbial shift in gut microbiota - Immuno-monitoring in peripheral blood - Monitoring of inflammatory markers in peripheral blood Phase 2: - PFS9, OS12, DOR - AEs, TEAEs, related, TEAEs, SAEs, DLTs per NCI-CTCAE version 5.0 - Dose reductions and interruptions - Detection and duration of Akkermansia p2261 colonization in stools - Microbial shift in gut microbiota - Immuno-monitoring in peripheral blood - Monitoring of inflammatory markers in peripheral blood;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Countries
Belgium, France
Contacts
Public ContactAlain Thibault
EverImmune SAS
Outcome results
None listed