18 and older, any sex, with Kidney Cancer or Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Initial Objective Response- First ParticipationPrimary· 12 weeks
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.
Yes (CR or PR)
Group
Value
95% CI
ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI)
5
ARM 2: Non-ICI Therapy
1
No (SD or PD)
Group
Value
95% CI
ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI)
7
ARM 2: Non-ICI Therapy
4
Initial Objective Response- Second ParticipationPrimary· 12 weeks
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.
Yes (CR or PR)
Group
Value
95% CI
ARM 3: Enrolled Consecutively in Both Arms
0
No (SD or PD)
Group
Value
95% CI
ARM 3: Enrolled Consecutively in Both Arms
1
Initial Relative Change in Tumor Burden Compared to Baseline - First ParticipationSecondary· 8-16 weeks after the start of treatment
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
Group
Value
95% CI
ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI)
-16.0
± 70.3
ARM 2: Non-ICI Therapy
43.7
± 94.8
Initial Relative Change in Tumor Burden Compared to Baseline - Second ParticipationSecondary· 8-16 weeks after the start of treatment
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
Group
Value
95% CI
ARM 3: Enrolled Consecutively in Both Arms
-20.7
± 0
Initial Per-Lesion Response Compared To Baseline - First ParticipationSecondary· 12 weeks
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.
Group
Value
95% CI
ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI)
-28.0
± 23.0
ARM 2: Non-ICI Therapy
-4.6
± 19.0
Initial Per-Lesion Response Compared To Baseline - Second ParticipationSecondary· 12 weeks
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.
Group
Value
95% CI
ARM 3: Enrolled Consecutively in Both Arms
-6.3
± 18.7
12-month Progression Free Survival (PFS)- First ParticipationSecondary· 12 months
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).
Yes (No PD and no death experienced)
Group
Value
95% CI
ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI)
7
ARM 2: Non-ICI Therapy
3
No (PD or death experienced)
Group
Value
95% CI
ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI)
4
ARM 2: Non-ICI Therapy
2
12-month Progression Free Survival (PFS)- Second ParticipationSecondary· 12 months
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.
Yes (No PD and no death experienced)
Group
Value
95% CI
ARM 3: Enrolled Consecutively in Both Arms
0
No (PD or death experienced)
Group
Value
95% CI
ARM 3: Enrolled Consecutively in Both Arms
1
Adverse events — posted to ClinicalTrials.gov
Time frame: First study ultrasound exam through 12 weeks after starting treatment..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI)
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stanford University
Last refreshed: 25 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04508725.