Sitravatinib and Nivolumab for the Treatment of Metastatic or Advanced Clear Cell Renal Cell Cancer
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|ClinicalTrials.gov Identifier: NCT04904302|
Recruitment Status : Not yet recruiting
First Posted : May 27, 2021
Last Update Posted : June 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Clear Cell Renal Cell Carcinoma Metastatic Clear Cell Renal Cell Carcinoma Stage IV Renal Cell Cancer AJCC v8||Biological: Nivolumab Other: Quality-of-Life Assessment Other: Questionnaire Administration Drug: Sitravatinib||Phase 2|
I. To determine the objective response rate (ORR) and disease control rate (DCR) at 24 weeks of sitravatinib 100 milligrams (mg) by mouth (PO) daily plus nivolumab 480 mg intravenously (IV) every 4 weeks in patients with metastatic renal cell carcinoma (mRCC) who progress on prior PD-1 or PD-L1 immune checkpoint inhibitors (CPIs), cabozantinib, or lenvatinib, as defined by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
I. To estimate the overall survival (OS), progression-free survival (PFS), duration of response (DOR), and 1-year OS of sitravatinib plus nivolumab in the same population.
II. To determine the safety, tolerability, and impact on health-related quality of life of sitravatinib plus nivolumab in patients with mRCC who progress on PD-1/PD-L1 CPIs, cabozantinib, or lenvatinib as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
I. To assess how the immune landscape, transcriptome, and genome change after contemporary first-line treatment via tumor tissue biopsy obtained at time of enrollment, 4 weeks after treatment with sitravatinib plus nivolumab, and at time of progression, as well as blood sample collection.
Patients receive sitravatinib PO once daily (QD) and nivolumab IV over 30 minutes on day 1. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Sitravatinib Plus Nivolumab in Patients With Metastatic Clear Cell Renal Cell Carcinoma Who Progressed on Prior Treatment Acronym: SNAPI (Sitravatinib and Nivolumab After Prior Immunotherapy)|
|Estimated Study Start Date :||July 1, 2021|
|Estimated Primary Completion Date :||January 10, 2023|
|Estimated Study Completion Date :||January 10, 2023|
Experimental: Treatment (sitravatinib, nivolumab)
Patients receive sitravatinib PO QD and nivolumab IV over 30 minutes on day 1. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Other Name: MGCD516
- Objective response rate [ Time Frame: At 24 weeks ]Will be defined as complete response + partial response. Will be defined by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
- Disease control rate [ Time Frame: At 24 weeks ]Will be defined by RECIST 1.1.
- Overall survival [ Time Frame: At 1 year ]Kaplan-Meier survival curves will be generated. Cox regression models will be fitted to assess the association between prognostic variables, and the survival endpoints.
- Progression free survival [ Time Frame: At 1 year ]Kaplan-Meier survival curves will be generated. Cox regression models will be fitted to assess the association between prognostic variables, and the survival endpoints.
- Duration of response [ Time Frame: At 1 year ]Kaplan-Meier survival curves will be generated. Cox regression models will be fitted to assess the association between prognostic variables, and the survival endpoints.
- Incidence of adverse events [ Time Frame: Up to 6 years ]Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will be summarized using descriptive statistics (e.g., frequency, 95% confidence interval) by type and grade.
- Health-related quality-of-life (QOL) [ Time Frame: Up to 24 weeks ]Will be assessed using the Functional Assessment of Cancer Therapy- Kidney Symptom Index- Disease Related Symptoms questionnaire. Descriptive statistics (e.g., means, ranges, standard deviations) will be computed, together with ninety-five percent confidence intervals for the means. Proportions of subjects falling outside normative ranges for the stress and QOL measures will also be calculated. Values for the standardized scales will be compared to normative data and patients receiving other types of cancer therapy. Graphical methods (e.g., boxplots and histograms) will be employed to more closely examine the distributions of the measures at each time point. Change scores for the stress and QOL measures will be computed as the simple differences between the baseline measure and subsequent evaluations. Paired t-tests will be used to evaluate the change of the stress and QOL measures between different time points.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04904302
|Contact: Pavlos Msaouelemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Contact: Pavlos Msaouel 713-563-4585 firstname.lastname@example.org|
|Principal Investigator: Pavlos Msaouel|
|Principal Investigator:||Pavlos Msaouel||M.D. Anderson Cancer Center|