A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal … (NCT04028245) | Clinical Trial Compass
CompletedEarly Phase 1
A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma
United States17 participantsStarted 2019-08-15
Plain-language summary
Primary Objective:
* To confirm the safety and feasibility of canakinumab and spartalizumab (PDR-001) administered using a standard dose / schedule in the neo-adjuvant setting in renal cell carcinoma
Secondary Objectives:
* To assess the immune response to combination canakinumab and spartalizumab
* To assess anti-tumor activity as measured by pathologic downstaging
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Radiographically consistent with or histologically confirmed clear cell RCC or predominantly clear cell RCC
* Localized non-metastatic RCC T1b-T4NanyM0 or TanyN1M0)
* Schedule to undergo either partial or radical nephrectomy as part of the treatment plan
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* Age ≥ 18 years old at time of consent
* HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes as defined by the following
* Cluster of differentiation 4 (CD4+) T cell counts ≥ 350 cells/microliter OR undetectable HIV viral load
* no history of AIDS-defining opportunistic infection in the last year
* Normal organ and marrow function as defined below:
* White blood cell count (WBC) \> 3.0 K/mm3
* Absolute neutrophil count (ANC) ≥ 1.5 K/mm3
* Platelets ≥ 100 K/mm3
* Hemoglobin (Hgb) ≥ 9 g/dL
* Serum total bilirubin: ≤ 1.5 x upper limit of normal (ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x ULN
* Serum creatinine ≤ 1.5 x ULN or serum creatinine \> 1.5 - 3 x ULN if calculated
* creatinine clearance (CrCl) is ≥ 30 mL/min
* For patients with known chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* For patients with a history of hepatitis C virus (HCV) infection, the infection must be treated and cured
* Willingness to provide written informed consent and HIPAA authorization for the release o…
What they're measuring
1
Percentage of subjects who proceed to radical nephrectomy