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| ID | Type | Description | Link |
|---|---|---|---|
| RENAL0042 | Other Identifier | OnCore | |
| NCI-2021-02327 | Registry Identifier | CTRP | |
| 1R03CA25277601 | Other Grant/Funding Number | NIH |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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To assess whether changes in quantitative tumor perfusion parameters after 3 or 6 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI) | Active Comparator | Patients are planned to be treated with vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI) |
|
| Non-ICI therapy | Active Comparator | Patients are planned to be treated with non-ICI therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doppler Ultrasound | Diagnostic Test | Power Doppler measurements will be made |
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| Measure | Description | Time Frame |
|---|---|---|
| Initial Objective Response- First Participation | Initial objective response was 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. | 12 weeks |
| Initial Objective Response- Second Participation | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Initial Relative Change in Tumor Burden Compared to Baseline - First Participation | Tumor burden was assessed as the sum of all tumor diameters at baseline compared to the first on-treatment response evaluation (8-16 weeks after the start of treatment) using RECIST v1.1 criteria | 8-16 weeks after the start of treatment |
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Inclusion Criteria:
Specific inclusion criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Alice C Fan, MD | Stanford University | Principal Investigator |
| Jeremy Dahl, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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A total of 22 participants were enrolled in the study. Twelve participants started in Arm 1 and five participants started in Arm 2. Additional two participants consecutively participated in both arms; these participants are reported in Arm 3.
Three participants were enrolled but did not start treatment and are not included in any arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI) | Patients were treated with vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI). |
| FG001 | ARM 2: Non-ICI Therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 1, 2023 | Nov 27, 2024 |
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| SIEMENS S3000 and Verasonics Vantage 256 | Device | Vantage 256 used for power Doppler ultrasound, manufactured by Verasonics |
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| Standard-of-care Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI) | Drug | Standard-of-care Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI). |
|
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| Standard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKI | Drug | Standard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKI |
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| Initial Relative Change in Tumor Burden Compared to Baseline - Second Participation |
Tumor burden was assessed as the sum of all tumor diameters at baseline compared to the first on-treatment response evaluation (8-16 weeks after the start of treatment) using RECIST v1.1 criteria |
| 8-16 weeks after the start of treatment |
| Initial Per-Lesion Response Compared To Baseline - First Participation | The relative change in tumor diameter of a single lesion between treatment 'baseline' and the first on-treatment response evaluation 8-16 weeks after the start of treatment, using RECIST v1.1 for tumor diameter measurements. This was measured as percent change and reported as mean ± standard deviation. | 12 weeks |
| Initial Per-Lesion Response Compared To Baseline - Second Participation | The relative change in tumor diameter of a single lesion between treatment 'baseline' and the first on-treatment response evaluation 8-16 weeks after the start of treatment, using RECIST v1.1 for tumor diameter measurements. This was measured as percent change and reported as mean ± standard deviation. | 12 weeks |
| 12-month Progression Free Survival (PFS)- First Participation | PFS was 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). | 12 months |
| 12-month Progression Free Survival (PFS)- Second Participation | 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. | 12 months |
Patients were treated with non-ICI therapy. |
| FG002 | ARM 3: Enrolled Consecutively in Both Arms | Patients were enrolled consecutively in both arms. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI) | Patients are planned to be treated with vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI) Doppler Ultrasound: Power Doppler measurements will be made. SIEMENS S3000 and Verasonics Vantage 256: Vantage 256 used for power Doppler ultrasound, manufactured by Verasonics. |
| BG001 | ARM 2: Non-ICI Therapy | Patients are planned to be treated with non-ICI therapy Doppler Ultrasound: Power Doppler measurements will be made. SIEMENS S3000 and Verasonics Vantage 256: Vantage 256 used for power Doppler ultrasound, manufactured by Verasonics. |
| BG002 | ARM 3: Enrolled Consecutively in Both Arms | Patients were enrolled consecutively in both arms. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Initial Objective Response- First Participation | Initial objective response was 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. | Two of fourteen participants in Arm 1 were not evaluable because they were removed from the study during active participation without undergoing any response evaluation. | Posted | Count of Participants | Participants | 12 weeks |
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| Primary | Initial Objective Response- Second Participation | 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. | This measure reflects outcome data from the second participation of two individuals enrolled in both Arm 1 and Arm 2. For their second participation, these individuals are grouped under Arm 3. Each participant is counted once in this outcome based on the second treatment period. For one of the two participants the outcome measure was not defined for their second treatment period. | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Initial Relative Change in Tumor Burden Compared to Baseline - First Participation | Tumor burden was assessed as the sum of all tumor diameters at baseline compared to the first on-treatment response evaluation (8-16 weeks after the start of treatment) using RECIST v1.1 criteria | Two of fourteen participants in Arm 1 were not evaluable because they were removed from the study during active participation without undergoing any response evaluation. | Posted | Mean | Standard Deviation | Percentage change from baseline | 8-16 weeks after the start of treatment |
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| Secondary | Initial Relative Change in Tumor Burden Compared to Baseline - Second Participation | Tumor burden was assessed as the sum of all tumor diameters at baseline compared to the first on-treatment response evaluation (8-16 weeks after the start of treatment) using RECIST v1.1 criteria | This measure reflects outcome data from the second participation of two individuals enrolled in both Arm 1 and Arm 2. For their second participation, these individuals are grouped under Arm 3. Each participant is counted once in this outcome based on the second treatment period. For one of the two participants the outcome measure was not defined for their second treatment period. | Posted | Mean | Standard Deviation | Percentage change from baseline | 8-16 weeks after the start of treatment |
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| Secondary | Initial Per-Lesion Response Compared To Baseline - First Participation | The relative change in tumor diameter of a single lesion between treatment 'baseline' and the first on-treatment response evaluation 8-16 weeks after the start of treatment, using RECIST v1.1 for tumor diameter measurements. This was measured as percent change and reported as mean ± standard deviation. | Two of fourteen participants in Arm 1 were not evaluable because they were removed from the study during active participation without undergoing any response evaluation. | Posted | Mean | Standard Deviation | Percentage change from baseline | 12 weeks | lesions | lesions |
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| Secondary | Initial Per-Lesion Response Compared To Baseline - Second Participation | The relative change in tumor diameter of a single lesion between treatment 'baseline' and the first on-treatment response evaluation 8-16 weeks after the start of treatment, using RECIST v1.1 for tumor diameter measurements. This was measured as percent change and reported as mean ± standard deviation. | The total number of participants analyzed for this outcome measure reflects only those who were evaluable. Two participants in Arm 1 were not evaluable because they were removed from the study during active participation without undergoing any response evaluation. One participant in Arm 3 received a treatment during the second participation, for which the outcome measure was not defined. | Posted | Mean | Standard Deviation | Percentage change from baseline | 12 weeks | lesions | lesions |
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| Secondary | 12-month Progression Free Survival (PFS)- First Participation | PFS was 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). | Three of fourteen patients in arm 1 were not evaluable. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | 12-month Progression Free Survival (PFS)- Second Participation | 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. | This outcome measure reflects 12-month progression-free survival for two participants who enrolled a second time after initial treatment. These participants are grouped under Arm 3, and each is counted once based on survival status from their second participation. For one participant the outcome measure was not defined for their second participation. | Posted | Count of Participants | Participants | 12 months |
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First study ultrasound exam through 12 weeks after starting treatment.
Only Adverse Events were recorded for this study that were definitely, probably, or possibly related to study procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI) | Patients were treated with vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI). | 1 | 12 | 0 | 12 | 2 | 12 |
| EG001 | ARM 2: Non-ICI Therapy | Patients were planned to be treated with non-ICI therapy | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | ARM 3: Enrolled Consecutively in Both Arms | Patients were enrolled consecutively in both arms. | 0 | 2 | 0 | 2 | 0 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alice Fan | Stanford University | (650) 498-6000 | afan@stanford.edu |
| Prot_001.pdf |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D018608 | Ultrasonography, Doppler |
| D020794 | Receptor Protein-Tyrosine Kinases |
| D000092004 | Tyrosine Kinase Inhibitors |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011505 | Protein-Tyrosine Kinases |
| D011494 | Protein Kinases |
| D017853 | Phosphotransferases (Alcohol Group Acceptor) |
| D010770 | Phosphotransferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D047428 | Protein Kinase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| lesions |
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| lesions |
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