At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 30 enrolled

Drug / intervention

Pembrolizumab +1 moredrug

Likely dose

Pembrolizumab 200mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02855203

NCT02855203Phase 2Completed

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Stereotactic Radiotherapy and Anti-PD1 Antibody (Pembrolizumab) for Oligometastatic Renal Tumours

Peter MacCallum Cancer Centre, Australia·interventional·Posted Aug 4, 2016·Updated Aug 3, 2023

In Brief

A Phase 2 clinical trial evaluating Stereotactic Ablative Body Radiosurgery (SABR) and Pembrolizumab for Renal Cell Carcinoma. Completed, enrolled 30 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsRenal Cell Carcinoma

CountriesAustralia

Collaborators--

Timeline

Phase 2CompletedFinished

2017201820192020202120222023202420252026

First PostedAug 2016

Enrollment StartOct 2016

Primary CompletionMay 2020

TodayJul 2026

First PostedAug 4, 2016

Enrollment StartOct 20, 2016

Primary CompletionMay 22, 2020

TodayJul 2, 2026

Enrollment to primary: 3.6 yearsPosted 9.9 years ago

Interventions

Stereotactic Ablative Body Radiosurgery (SABR)radiation

18-20Gy in 1 fraction

Pembrolizumabdrug

Pembrolizumab at a dose of 200mg IV, 3-weekly will be delivered for a duration of 6 months, commencing 5 days (+/- 3 days) from the last dose of SABR.