18 and older, any sex, with 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.
Toxicities Measured Using CTCAE Version 4.03Primary· Up to 24 months after SABR treatment
Number of Participants with Grade 3 Treatment Related Adverse Events as determined using CTCAE version 4.03 criteria. This standard criteria can be found through National Cancer Institute (https://ctep.cancer.gov/protocoldevelopment/electronic\_applications/ctc.htm). Grade 3 treatment-related events are high grade toxicities.
Group
Value
95% CI
SABR + Pembrolizumab
4
Overall SurvivalSecondary· From start of treatment until the date of death from any cause assessed up to 2 years
Group
Value
95% CI
SABR + Pembrolizumab
74
Freedom From Local Progression (FFLP)Secondary· From start of treatment until the date of first local progression or until the date of death from any cause, whichever occurs first, assessed up to 2 years
Freedom from local progression (FFLP) was defined as the absence of progressive disease by the Response Evaluation Criteria in Solid Tumors criteria
Group
Value
95% CI
SABR + Pembrolizumab
92
80 – 97
Distant Progression Free Survival (DPFS)Secondary· From start of treatment until the date of first distant progression or until the date of death from any cause, whichever occurs first, assessed at 2 years
Percentage of Participants with Distant Progression Free Survival (DPFS)
Group
Value
95% CI
SABR + Pembrolizumab
52
33 – 69
Overall Response Assessed Using RECIST 1.1Secondary· 24 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Group
Value
95% CI
SABR + Pembrolizumab
63
44 – 80
Pain Assessed Using the Numerical Pain Rating ScaleSecondary· From commencement of treatment up to 2 years.
The number of patients who reported a pain score \>0 at least once after treatment. Numerical Pain Rating Score, 0-10 scale with 0 representing no pain, to 10 representing the worst possible pain.
Group
Value
95% CI
SABR + Pembrolizumab
22
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 2 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This investigator driven study will examine the safety, efficacy and biological effects of combining pembrolizumab (MK-3475) an antibody targeted against anti-programmed cell death 1 (PD-1), with stereotactic ablative body radiotherapy (SABR) for oligometastatic renal cell carcinoma (RCC). The investigators hypothesise that the safety profile of this combination will be clinically acceptable.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07195682 — A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
· Phase 1
· recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr
· Phase 2
· recruiting
NCT07227402 — A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6
· Phase 3
· recruiting
NCT07123090 — A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma
· Phase 2
· recruiting
Other Peter MacCallum Cancer Centre, Australia trials
Trials by the same sponsor.
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· recruiting
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· recruiting
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· NA
· active not recruiting
NCT07090369 — Phase Ib Trial of 177Lu-PSMA-I&T Therapy in Combination With Olaparib and Pembrolizumab in Patients With Metastatic Cast
· Phase 1
· not yet recruiting
NCT07139782 — Home-Based Photo-Biomodulation for Management of Lymphoedema and Radiation Fibrosis in Patients After Head and Neck Canc
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· 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 Peter MacCallum Cancer Centre, Australia
Last refreshed: 3 August 2023
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/NCT02855203.