Adults 18 to 99, any sex, with Metastatic Clear Cell 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.
Response RatePrimary· 6 months
Treatment response will be measured using the immune related Response Evaluation Criteria in Solid Tumors (RECIST) criteria (iRECIST) which are a minor modification of RECIST 1.1 for immunotherapy
Group
Value
95% CI
Treatment
4
Overall SurvivalSecondary· 4 years
Overall Survival (OS), which is defined as the time between date of registration and the date of death due to any cause.
Group
Value
95% CI
Treatment
39
16 – 53
Progression Free SurvivalSecondary· 4 years
Progression Free Survival (PFS), which is defined according to the immune Response Evaluation Criteria in Solid Tumors (iRECIST) as the time between date of registration and the first date of documented disease progression or date of death due to any cause.
Group
Value
95% CI
Treatment
2.5
2 – 8
Local Control RateSecondary· 4 years
Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of \> 20% in tumor size.
Group
Value
95% CI
Treatment
30
Median Response DurationSecondary· 4 years
Median response duration, which is defined as the time between the date a response (CR or PR) was first seen until date of progression
Group
Value
95% CI
Treatment
26.7
11.4 – 36.4
Number of Participants With Adverse EventsSecondary· 4 years
Adverse events will be determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Group
Value
95% CI
Treatment
30
Adverse events — posted to ClinicalTrials.gov
Time frame: 4 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky progressive disease, but also to provide antigen presentation and immune stimulation which is expected to act synergistically when immediately followed by the non-specific immune stimulation provided by treatment with HD IL-2 and thereby increase the response rate and complete response for metastatic clear cell renal cell cancer patients. Both HD IL-2 and SABR are FDA approved therapeutic cancer treatment
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06158828 — Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML
· Phase 1, PHASE2
· recruiting
NCT06302062 — Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors
· Phase 1
· recruiting
NCT05336409 — A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies
· Phase 1
· terminated
NCT05603013 — Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 f
· Phase 2
· unknown
NCT05400122 — Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Recepto
· Phase 1
· suspended
Other recruiting trials for Metastatic Clear Cell Renal Cell Carcinoma
Currently open trials in the same condition.
NCT07128680 — Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Met
· Phase 1
· recruiting
NCT07179770 — Effects of Belzutifan on 89Zr-DFO-girentuximab PET Uptake in Patients With Renal Cell Carcinoma (RCC)
· Phase 1
· recruiting
NCT06866262 — Inulin Gel in Combination With Ipilimumab and Nivolumab for the Treatment of Metastatic or Locally Advanced Kidney Cell
· Phase 1, PHASE2
· recruiting
NCT06942104 — Imaging of Solid Tumors Using 18F-TRX
· Phase 1
· recruiting
NCT06399419 — CBM588 Capsules in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer
· Phase 1
· recruiting
Other University of Texas Southwestern Medical Center trials
Trials by the same sponsor.
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· recruiting
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· NA
· not yet recruiting
NCT05145309 — Value of Potassium Magnesium Citrate in Preventing and Treating Hypertension in African Americans
· Phase 2
· not yet recruiting
NCT06552000 — Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer
· NA
· not yet recruiting
NCT07387666 — Imaging Acetadote Metabolism in Glioblastoma
· EARLY_PHASE1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
Last refreshed: 23 August 2021
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/NCT01896271.