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

Part of paid clinical trials in Duarte, California.

Sponsor
Osel, Inc.
Study ID
NCT06399419
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Clear Cell Renal Cell Carcinoma
  • Advanced Renal Cell Carcinoma
  • Advanced Sarcomatoid Renal Cell Carcinoma
  • Metastatic Clear Cell Renal Cell Carcinoma
  • Metastatic Renal Cell Carcinoma
  • Metastatic Sarcomatoid Renal Cell Carcinoma
  • Stage III Renal Cell Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • CBM588 Capsules — BIOLOGICAL
    Given PO
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Jun 19, 2024
Status verified
May 2024
Primary completion
Oct 19, 2026
Completion
Oct 19, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (CBM588 capsules, nivolumab, ipilimumab)
    Patients receive CBM588 PO BID on days 1-21, nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 4 cycles. Patients then receive CBM588 PO BID on days 1-28 and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT, bone scan and blood sample collection throughout the study. Patients may optionally undergo MRI on study.

Primary Outcome Measure

Dose limiting toxicity (DLT) [ Time Frame: Up to 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Alex Chehrazi-Raffle, MD
[email protected]
626-218-4772
Alex Chehrazi-Raffle, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
City of Hope Medical Center· Duarte, CA

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