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.
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, …
Contacts
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