2023
Effect of CBM588 in combination with cabozantinib plus nivolumab for patients (pts) with metastatic renal cell carcinoma (mRCC): A randomized clinical trial.
Ebrahimi H, Meza L, Lee K, Malhotra J, Alcantara M, Zengin Z, Dizman N, Govindarajan A, Hsu J, Llamas-Quitiquit M, Chawla N, Castro D, Mercier B, Liu S, Chehrazi-Raffle A, Dorff T, Frankel P, Li X, Pal S, Tripathi A. Effect of CBM588 in combination with cabozantinib plus nivolumab for patients (pts) with metastatic renal cell carcinoma (mRCC): A randomized clinical trial. Journal Of Clinical Oncology 2023, 41: lba104-lba104. DOI: 10.1200/jco.2023.41.17_suppl.lba104.Peer-Reviewed Original ResearchMetastatic renal cell carcinomaProgression-free survivalTyrosine kinase inhibitorsPrimary endpointClinical outcomesStool specimensDual immune checkpoint inhibitorsMedian progression-free survivalImproved progression-free survivalOne-sided type I errorBifidobacterium sppGrade 3/4 toxicitiesImmune checkpoint inhibitorsStudy's primary endpointWeeks of treatmentDose/scheduleRandomized clinical trialsRenal cell carcinomaEligible ptsPo bidSystemic immunomodulationCheckpoint inhibitorsSecondary endpointsLine therapyMetastatic disease
2022
A phase I trial to evaluate the biologic effect of CBM588 (Clostridium butyricum) in combination with cabozantinib plus nivolumab for patients with metastatic renal cell carcinoma (mRCC).
Meza L, Malhotra J, Zengin Z, Dizman N, Hsu J, Chawla N, Chehrazi-Raffle A, Muddasani R, Govindarajan A, Castro D, Dorff T, Lyou Y, Frankel P, Pal S. A phase I trial to evaluate the biologic effect of CBM588 (Clostridium butyricum) in combination with cabozantinib plus nivolumab for patients with metastatic renal cell carcinoma (mRCC). Journal Of Clinical Oncology 2022, 40: tps4606-tps4606. DOI: 10.1200/jco.2022.40.16_suppl.tps4606.Peer-Reviewed Original ResearchMetastatic renal cell carcinomaClinical responseClear cell metastatic renal cell carcinomaTyrosine kinase inhibitor cabozantinibBiologic effectsGut microbiomeImmune checkpoint inhibitor nivolumabOne-sided type I errorPhase I clinical trialFirst-line treatmentProgression-free survivalStudy's primary endpointCheckpoint inhibitor nivolumabPhase I trialPhase 1 trialSubgroup of patientsWeeks of treatmentCytokines/chemokinesDose/scheduleOngoing phase IRenal cell carcinomaImproved clinical benefitBifidobacterium sppEligible patientsPo bid