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Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

Primary Purpose

Kidney Cancer, Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Doppler Ultrasound
Vantage 256 with C5-2v transducer
Vascular Endothelial Growth Factor Receptor 2 tyrosine kinase inhibitor
non-ICI therapy
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kidney Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older
  • Pathology-confirmed diagnosis of metastatic RCC now
  • at least one tumor lesion greater than 1 cm in diameter, amenable to ultrasound imaging
  • planned to be treated with VEGFR2 tyrosine kinase inhibitor plus immune checkpoint inhibitor
  • written informed consent.

Exclusion Criteria:

-Any comorbid condition that, in the opinion of the treating provider or the Protocol Directors, compromises the participant's ability to participate in the study.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tyrosine kinase (TKI) inhibitor plus immune checkpoint inhibitor (ICI)

Non-ICI therapy

Arm Description

Patients are planned to be treated with vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)

Patients are planned to be treated with non-ICI therapy

Outcomes

Primary Outcome Measures

Measure Initial Objective response
Initial objective response is defined as having either Complete Response (CR) or Partial Response (PR) per RECIST v1.1 at first on-treatment response evaluation 8-16 weeks after initiating treatment. The results will be expressed as number without dispersion.

Secondary Outcome Measures

Relative change in tumor burden compared to baseline
Relative change will be assessed as sum of all tumor diameters between treatment 'baseline' and first on-treatment response evaluation 8-16 weeks after start of treatment, using RECIST v1.1 for tumor diameter measurements, expressed as mean +/- standard deviation and median with interquartile range
Lesion response compared to baseline
Relative change in tumor diameter of a single lesion between treatment 'baseline' and first on-treatment response evaluation 8-16 weeks after start of treatment, using RECIST v1.1 for tumor diameter measurements, will be measured as mean +/- standard deviation and median with interquartile range.
Progression free survival (PFS)
PFS is defined as not having experienced any progressive disease (PD) per RECIST v1.1 within the first 12 months after initiating treatment (day 1 will be treatment start date), as a number and proportion without dispersion.

Full Information

First Posted
July 29, 2020
Last Updated
August 11, 2023
Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04508725
Brief Title
Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)
Official Title
Early Therapeutic Monitoring of Response to Therapy With Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 5, 2020 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To assess whether changes in quantitative tumor perfusion parameters after 3 weeks of treatment, as measured by power doppler ultrasound, can predict initial objective response, defined by current standard-of-care, to therapy at 12 weeks after start of treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer, Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tyrosine kinase (TKI) inhibitor plus immune checkpoint inhibitor (ICI)
Arm Type
Experimental
Arm Description
Patients are planned to be treated with vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
Arm Title
Non-ICI therapy
Arm Type
Experimental
Arm Description
Patients are planned to be treated with non-ICI therapy
Intervention Type
Diagnostic Test
Intervention Name(s)
Doppler Ultrasound
Intervention Description
Power doppler measurements will be made
Intervention Type
Device
Intervention Name(s)
Vantage 256 with C5-2v transducer
Intervention Description
Vantage 256 with C5-2v transducer, used for power doppler ultrasound, manufactured by Verasonics
Intervention Type
Drug
Intervention Name(s)
Vascular Endothelial Growth Factor Receptor 2 tyrosine kinase inhibitor
Other Intervention Name(s)
VEGFR2, TKI
Intervention Description
Participants will receive less than 4 weeks of TKI treatment during the first 12 weeks
Intervention Type
Other
Intervention Name(s)
non-ICI therapy
Intervention Description
TKI monotherapy, combination of TKI with other kinase inhibitor, localized tumor therapy such as radiation, chemo- or radioembolization
Primary Outcome Measure Information:
Title
Measure Initial Objective response
Description
Initial objective response is defined as having either Complete Response (CR) or Partial Response (PR) per RECIST v1.1 at first on-treatment response evaluation 8-16 weeks after initiating treatment. The results will be expressed as number without dispersion.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Relative change in tumor burden compared to baseline
Description
Relative change will be assessed as sum of all tumor diameters between treatment 'baseline' and first on-treatment response evaluation 8-16 weeks after start of treatment, using RECIST v1.1 for tumor diameter measurements, expressed as mean +/- standard deviation and median with interquartile range
Time Frame
12 weeks
Title
Lesion response compared to baseline
Description
Relative change in tumor diameter of a single lesion between treatment 'baseline' and first on-treatment response evaluation 8-16 weeks after start of treatment, using RECIST v1.1 for tumor diameter measurements, will be measured as mean +/- standard deviation and median with interquartile range.
Time Frame
12 weeks
Title
Progression free survival (PFS)
Description
PFS is defined as not having experienced any progressive disease (PD) per RECIST v1.1 within the first 12 months after initiating treatment (day 1 will be treatment start date), as a number and proportion without dispersion.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Pathology-confirmed diagnosis of metastatic RCC At least one tumor lesion greater than 1 cm in diameter, amenable to ultrasound imaging Written informed consent. Specific inclusion criteria: arm 1: planned to be treated with combination of VEGFR2 tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI) arm 2: planned to be treated with non-ICI therapy Exclusion Criteria: -Any comorbid condition that, in the opinion of the treating provider or the Protocol Directors, compromises the participant's ability to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice C Fan, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeremy Dahl, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

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