Sitravatinib for Kidney Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Kidney Neoplasms+6 More
Sitravatinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether sitravatinib and nivolumab are safe and effective in treating patients with kidney cancer that has spread to other places in the body.

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Eligible Conditions

  • Kidney Neoplasms
  • Stage III Renal Cell Cancer AJCC v7
  • Metastatic Kidney Carcinoma
  • Clear Cell Renal Cell Carcinoma (ccRCC)
  • Stage IV Renal Cell Cancer AJCC v7

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Sitravatinib will improve 2 primary outcomes and 4 secondary outcomes in patients with Kidney Neoplasms. Measurement will happen over the course of Up to 6 weeks.

Up to 12 weeks
Incidence of adverse events
Up to 6 weeks
Efficacy (defined as achieving complete remission, partial remission or stable disease)
Up to 6 years
Objective response rate
Overall survival time
Progression free survival time
The Functional Assessment of Cancer Therapy (FACT) will be used to measure cancer-specific health-related quality of life

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Treatment (sitravatinib, nivolumab)
1 of 1
Experimental Treatment

This trial requires 42 total participants across 1 different treatment group

This trial involves a single treatment. Sitravatinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Treatment (sitravatinib, nivolumab)Patients receive sitravatinib PO QD on days 1-14 and receive nivolumab IV over 60 minutes on day 1 starting cycle 2. Cycles repeat every 14 days for cycles 1-6 and then every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity. Patients who receive at least 6 infusions of nivolumab with no DLTs related to nivolumab, may then receive nivolumab every 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sitravatinib
Not yet FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 years for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients who have received one or two prior anti-angiogenic therapies and who have a clear cell component of renal cell carcinoma are eligible for this study show original
The patient must show evidence of progression on or after their last treatment regimen and within 6 months of enrollment in the study. show original
therapy Patients must have at least one measurable site of disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures >= 15 mm with conventional techniques or >= 10 mm with more sensitive techniques such as magnetic resonance imaging (MRI) or spiral computed tomography (CT) scan; if the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation therapy. show original
The participant must have a total bilirubin level of 1.5 milligrams per deciliter or less within 14 days prior to study entry. show original
In most cases, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels should be less than 2.5 times the institutional upper limit of normal show original
Individuals with creatinine levels below 1.5 times the upper limit of the normal range (uln) may receive a blood transfusion show original
This is a statement that means that the individual has a Karnofsky performance status of greater than or equal to 70. show original
A person is allowed to participate in the study if their hemoglobin level is greater than or equal to 9 grams per deciliter show original
The subject must have an absolute neutrophil count of at least 1,500/uL within 14 days prior to study entry. show original
Platelets >= 100,000/uL (within 14 days prior to study entry)

Patient Q&A Section

What are common treatments for carcinoma, renal cell?

"Tumor treatment is highly individualized and tailored. Given the prevalence of kidney cancer, however, the information provided by the Mayo Clinic to help patients with this disease is both helpful and necessary." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma, renal cell?

"Nephromyelo-sarcoma may present with a small, non-symptomatic, red-blood cell mass in the renal and urinary tract, or as an asymptomatic haematuria. Haematuria in a young man should lead to prompt investigation for carcinoma." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, renal cell?

"Even though no cause has been found for all types of RCC, there is a clear relationship between the occurrence of certain risk factors and the development of the disease in patients with renal failure." - Anonymous Online Contributor

Unverified Answer

Can carcinoma, renal cell be cured?

"If carcinoma of the renal cortex, renal capsule and/or distal convoluted tubulla is successfully surgically removed, this can be an end-stage renal disease if not recurrent and well treated. If recurrence occurs, repeated surgeries can be necessary to improve the patient's condition. However, only a tiny percentage of patients who are successfully treated become disease-free." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, renal cell?

"Carcinoma, renal cell is the most common type of renal cancer. It is the major cause of kidney failure-related death in developing countries, such as Pakistan. The most common forms of skin cancer are Basal cell carcinoma, Squamous cell carcinoma and Malignant Melanoma of the Non-Acquired type. The prevalence of this disease continues to increase across the world due to environmental factors, as a part of the non-communicable disease cluster associated with tobacco use." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma, renal cell a year in the United States?

"The incidence of renal cell carcinoma in the United States is increasing. The incidence of other types of renal cell carcinomas remain stable. As the incidence of renal cell carcinoma increases, physicians' attention to the diagnosis of renal cell carcinoma is important because renal cell carcinoma is relatively treatable." - Anonymous Online Contributor

Unverified Answer

Is sitravatinib safe for people?

"The rate of dose-limiting toxicities was low in this study. There was no evidence of renal function impairment at doses up to 100 mg bid." - Anonymous Online Contributor

Unverified Answer

How does sitravatinib work?

"Stat3 plays a key role in cancer progression and survival. Sitravatinib acts as an inhibitor of vascular endothelial growth factor (VEGF) receptor (VEGFR)-2, which leads to suppression of angiogenesis and tumor vasculature growth, and consequent tumor shrinkage." - Anonymous Online Contributor

Unverified Answer

What is the latest research for carcinoma, renal cell?

"The current research is using clinical trials as part of the treatment and management of carcinoma, renal cell. Some of the cancers patients may use trials that can be prescribed to improve their chances of keeping alive and well after cancer treatments. Some of the cancers that are being studied are kidney cancer, breast cancer, prostate cancer, colorectal cancer, and non-small-cell lung cancer. These cancer treatments can get better as the cancer clinical trial research goes on." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving sitravatinib?

"Sitavatinib is a promising drug. We present data showing that sitavatinib inhibits the growth of a wide range of human solid and liquid tumors that exhibit a range of phenotypes. Sitavatinib deserves further development for a variety of indications." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma, renal cell spread?

"The overall survival of patients with metastatic renal cell carcinoma in the U.S. with metastatic disease can be improved by combining aggressive surgical intervention for cancer and aggressive chemotherapy that should focus on metastatic disease." - Anonymous Online Contributor

Unverified Answer

Has sitravatinib proven to be more effective than a placebo?

"This pilot study, involving six patients, is the first report describing the safety and antitumor activity of sitravatinib, in vitro and in vivo, in human malignant cells. The antitumor activity of sitravatinib in this pilot study suggests that its use might have a role in the treatment of patients with advanced RCC." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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