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©2022 Stanford Medicine
Not Recruiting
Trial ID: NCT02655822
A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose-Selection Study of Ciforadenant as Single Agent and in Combination With Atezolizumab in Patients With Selected Incurable Cancers
Professor of Medicine (Oncology)
Professor of Medicine (Oncology) and, by courtesy, of Urology
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Renal Cell Carcinoma Inclusion Criteria
1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
2. Documented pathologic diagnosis of clear cell RCC.
3. Relapsed or refractory to 1-2 prior lines of therapy containing at least an
anti-PD-(L)1 agent.
4. Measurable disease according to RECIST v1.1
5. Mandatory newly collected tumor biopsy sample obtained prior to treatment initiation.
Renal Cell Carcinoma Exclusion Criteria
1. History of severe hypersensitivity reaction to monoclonal antibodies.
2. Has immunodeficiency or requires treatment with systemic immunosuppressive medication
within 2 weeks prior to initiation of study treatment or anticipation of need for
systemic immunosuppressant medication during study treatment.
3. Has an active autoimmune disease requiring systemic treatment with in the past 2 years
OR a documented history of clinically severe autoimmune disease.
Metastatic Castration-Resistant Prostate Cancer Inclusion Criteria
1. Documentation of disease: progressive CRPC with histologically or cytologically
confirmed adenocarcinoma of the prostate.
2. Patients must have radiologically evident metastatic disease, but it can be measurable
or non-measurable disease:
- Measurable disease: nodal, visceral, or extra nodal lesions according to RECIST
v1.1 using a diagnostic computed tomography
- Non-measurable disease: bone only disease (up to 1/3 of study population) per
PCWG3 criteria
3. 1-3 prior lines of therapy, including at least one newer generation androgen synthesis
inhibitor (e.g., abiraterone) or androgen receptor antagonist (e.g., enzalutamide,
apalutamide, darolutamide).
4. Mandatory newly collected tumor biopsy sample obtained prior to treatment initiation.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
Metastatic Castration-Resistant Prostate Cancer Exclusion Criteria
1. Has pure small-cell histology and variants with predominant (≥ 50%) neuroendocrine
differentiation.
2. Has a history of severe hypersensitivity reaction to monoclonal antibodies.
3. Has immunodeficiency or requires treatment with systemic immunosuppressive medication
within 2 weeks prior to initiation of study treatment or anticipation of need for
systemic immunosuppressant medication during study treatment.
4. Has an active autoimmune disease requiring systemic treatment with in the past 2 years
OR a documented history of clinically severe autoimmune disease.
drug: Ciforadenant
drug: Ciforadenant
drug: Ciforadenant
drug: Ciforadenant + atezolizumab
drug: Ciforadenant
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Melanie Ashland
650-723-0669