Health Trials

CBM588 Capsules in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer

ConditionsAdvanced Clear Cell Renal Cell CarcinomaAdvanced Renal Cell CarcinomaAdvanced Sarcomatoid Renal Cell CarcinomaMetastatic Clear Cell Renal Cell CarcinomaMetastatic Renal Cell CarcinomaMetastatic Sarcomatoid Renal Cell CarcinomaStage III Renal Cell Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOsel, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Prior treatment with ipilimumab and/or nivolumab

Current use, or intent to use, probiotics, yogurt, or bacterial fortified foods during the period of treatment

History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent

Active interstitial lung disease (ILD)/pneumonitis or history of ILD/pneumonitis requiring treatment with systemic steroids

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Bone Scan
  • CBM588 Capsules
  • Computed Tomography
  • Ipilimumab
  • Magnetic Resonance Imaging
  • Nivolumab

Treatment groups

28 Participants
are divided into 1 treatment group

Sponsors and collaborators

Osel, Inc.

Lead sponsor

City of Hope Medical Center

Collaborator

Miyarisan Pharmaceuticals, Co., Ltd.

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov