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

Recruiting Phase 2 Interventional Study
Clear Cell Renal Cell Carcinoma Sarcomatoid Renal Cell Carcinoma Stage II Renal Cell Cancer AJCC v8 Stage III Renal Cell Cancer AJCC v8 Stage IV Renal Cell Cancer AJCC v8
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
62 (estimated)
Sponsor
City of Hope Medical Center · Other
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About This Trial
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, a…
Trial Locations
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Eligibility Criteria
Inclusion 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, …
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