Trials / Completed
CompletedNCT02855203
Stereotactic Radiotherapy and Anti-PD1 Antibody (Pembrolizumab) for Oligometastatic Renal Tumours
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Peter MacCallum Cancer Centre, Australia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Dual institutional, single arm, unblinded, phase I/II study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Stereotactic Ablative Body Radiosurgery (SABR) | 18-20Gy in 1 fraction |
| DRUG | Pembrolizumab | 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. |
Timeline
- Start date
- 2016-10-20
- Primary completion
- 2020-05-22
- Completion
- 2020-05-22
- First posted
- 2016-08-04
- Last updated
- 2023-08-03
- Results posted
- 2023-08-03
Locations
2 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT02855203. Inclusion in this directory is not an endorsement.