SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02626130

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Pilot Study of Tremelimumab With or Without Tissue Cryoablation in Patients With Metastatic Renal Cell Carcinoma

This randomized pilot clinical trial studies the side effects of tremelimumab with or without tissue cryoablation in treating patients with kidney cancer that has spread to other places in the body. Tremelimumab binds to a protein called cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), which is found on the surface of T cells (a type of white blood cell). Tremelimumab may block CTLA-4 and help the immune system kill cancer cells. Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue. It is not yet known whether tremelimumab with or without cryoablation is effective in treating patients with kidney cancer.

NCT02626130 Clear Cell Renal Cell Carcinoma Metastatic Renal Cell Cancer Stage IV Renal Cell Cancer AJCC v7
MeSH: Carcinoma Carcinoma, Renal Cell
HPO: Carcinoma Clear cell renal cell carcinoma Papillary renal cell carcinoma Renal cell carcinoma

4 Interventions

Name: Cryosurgery

Description: Undergo cryoablation

Type: Procedure

Arm B (tremelimumab and cryoablation)

Name: Laboratory Biomarker Analysis

Description: Correlative studies

Type: Other

Arm A (tremelimumab) Arm B (tremelimumab and cryoablation)

Name: Therapeutic Conventional Surgery

Description: Undergo surgery

Type: Procedure

Arm A (tremelimumab) Arm B (tremelimumab and cryoablation)

Name: Tremelimumab

Description: Given IV

Type: Biological

Arm A (tremelimumab) Arm B (tremelimumab and cryoablation)


Primary Outcomes

Description: Safety will be recorded through the incidence of adverse events, serious adverse events and specific laboratory abnormalities (worst grade) in each treatment arm. Descriptive statistical analyses will be performed to summarize the incidence of adverse events.

Measure: Incidence of adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

Time: Up to 2 weeks

Description: Extreme toxicities will be defined as any grade 3 or higher adverse event that is possibly, probably, or definitely related to therapy that occurs within the first two cycles of therapy with the following exceptions: any grade 3 or higher adverse event that is potentially treatable with steroids will only count as an extreme toxicity if it does not improve to grade 1 or better within 2 weeks of steroid therapy, grade 3 or 4 amylase or lipase abnormalities that are not associated with symptoms or clinical manifestations of pancreatitis, or grade 3 or 4 drug related endocrinopathies which within two weeks of presentation are adequately controlled with only physiologic hormone replacement therapy.

Measure: Incidence of extreme toxicities as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

Time: Up to 2 weeks

Secondary Outcomes

Description: Descriptive statistical analyses will be performed to summarize the response rate including summary tables, scatter-plots, box-plots, proportions, 95% credible intervals, median, means, and standard deviations.

Measure: Response rate

Time: Up to 5 years

Description: Differences of indication markers between arms will be compared using a t-test with transformations of non-normal data, as needed. A mixed model accounting for patient effects will be used to analyze the longitudinal data on immunological values over time.

Measure: Changes in indication markers

Time: Up to 5 years

Description: Descriptive statistical analyses will be performed.

Measure: Progression free survival

Time: Up to 5 years

Description: A mixed model accounting for patient effects will be used to analyze the longitudinal data on immunological values over time.

Measure: Longitudinal data on immunological values over time

Time: Up to 13 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 Q12W

After surgery or biopsy, patients receive tremelimumab IV every 4 weeks (Q4W) for 3 doses, and then every 12 weeks (Q12W) in the absence of disease progression or unacceptable toxicity. --- Q12W ---

After surgery or biopsy, patients receive tremelimumab IV Q4W for 3 doses, and then Q12W in the absence of disease progression or unacceptable toxicity. --- Q12W ---



HPO Nodes


HPO:
Carcinoma
Genes 11
PTEN CDKN1B APC MLH1 MSH2 FGFR3 KIT DKC1 RSPO1 STK11 NLRP1
Clear cell renal cell carcinoma
Genes 1
NOD2
Papillary renal cell carcinoma
Genes 8
FOXE1 LMNA HABP2 CDC73 MET MINPP1 PRCC FH
Renal cell carcinoma
Genes 52
FOXE1 VHL MET STK11 HNF1A HNF1B KLLN DLC1 NRAS FN1 LMNA SDHAF2 PIK3CA PRCC MAX KIF1B SRC SLC49A4 BUB1B APC FLCN COL14A1 AKT1 TSC1 TSC2 HABP2 FGFR3 CDC73 KEAP1 MINPP1 CTNNB1 RET DCC FH MDH2 PTEN RNF139 HNF4A AAGAB TMEM127 OGG1 DICER1 EP300 SEC23B SDHA SDHB TFE3 SDHC SDHD AXIN2 BAP1 NOD2