Osel, Inc.
This phase I trial tests the safety, side effects, best dose, and effectiveness of CBM588 in combination with nivolumab and ipilimumab in treating patients with kidney cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). CBM588 is a live biotherapeutic that may help improve the effects of immunotherapy. Nivolumab and ipilimumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread by enhancing the ability of the body's immune cells to attack tumor cells. CBM588 in combination with nivolumab and ipilimumab may be safe, tolerable, and/or effective in treating patients with advanced stage kidney cancer.
PRIMARY OBJECTIVE: I. To evaluate the safety and tolerability of nivolumab/ipilimumab with escalating doses of Clostridium butyricum MIYAIRI 588 capsules (CBM588) in patients with metastatic renal cell carcinoma. SECONDARY OBJECTIVES: I. To evaluate the effect of CBM588 on the clinical efficacy of nivolumab/ipilimumab. II. To determine the effect of CBM588 (in combination with nivolumab/ipilimumab) in modulation of the gut microbiome in patients with metastatic renal cell carcinoma. III. To assess the effect of CBM588 on the change of metabolic pathways with the nivolumab/ipilimumab combi…
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principle investigator (PI) approval * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Age ≥ 18 years * Histologically confirmed renal cell carcinoma with clear cell renal cell carcinoma component or sarcomatoid component * Advanced (not amenable to curative surgery or radia…
Undergo blood sample collection
Undergo bone scan
Given PO
Undergo CT
Given IV
Undergo MRI
Given IV