Adding a Live Biotherapeutic Product (CBM588) to Pembrolizumab for the Treatment of Renal Cell Cancer After Surgery

This phase II trial compares the effect of adding a Live Biotherapeutic Product called CBM588 to pembrolizumab versus pembrolizumab alone in preventing return of disease (recurrence) after surgery for patients with renal cell cancer. Pembrolizumab is an immune checkpoint inhibitor. Immunotherapy with monoclonal antibodies such as pembrolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab is approved for the treatment of renal cell cancer after surgery. Research has shown that changes to the composition

Trial Details

NCT ID
NCT07037004
Phase
PHASE2
Sponsor
City of Hope Medical Center
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • Biospecimen Collection
  • Clostridium butyricum CBM588 Strain
  • Computed Tomography
  • Pembrolizumab
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Irvine, California, United States|33.66946,-117.82311

Key Eligibility Criteria

  • Be willing and able to provide informed consent for the trial
  • Histological confirmation of renal cell carcinoma (RCC) with a clear-cell or sarcomatoid component
  • Pathologic stage of pT2, G4 or sarcomatoid, N0M0; pT3, any grade, N0M0; pT4, any grade, N0M0; pTany, any grade, N+M0; or M1 no evidence of disease …
  • No prior systemic immunotherapy for RCC

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Kidney Cancer Trials on Trialify →