Trial Outcomes & Findings for Stereotactic Radiotherapy and Anti-PD1 Antibody (Pembrolizumab) for Oligometastatic Renal Tumours (NCT NCT02855203)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Up to 24 months after SABR treatment

Results posted on

2023-08-03

Participant Flow

Participant milestones

Participant milestones
Measure	SABR + Pembrolizumab SABR treatment (18Gy-20Gy/1#) followed by 200mg pembrolizumab IV once every 3 weeks for a total of 8 cycles Stereotactic Ablative Body Radiosurgery (SABR): 18-20Gy in 1 fraction 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.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SABR + Pembrolizumab n=30 Participants SABR treatment (18Gy-20Gy/1#) followed by 200mg pembrolizumab IV once every 3 weeks for a total of 8 cycles Stereotactic Ablative Body Radiosurgery (SABR): 18-20Gy in 1 fraction 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.
Age, Continuous	62 years n=30 Participants
Sex: Female, Male Female	7 Participants n=30 Participants
Sex: Female, Male Male	23 Participants n=30 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SABR + Pembrolizumab n=30 Participants SABR treatment (18Gy-20Gy/1#) followed by 200mg pembrolizumab IV once every 3 weeks for a total of 8 cycles Stereotactic Ablative Body Radiosurgery (SABR): 18-20Gy in 1 fraction 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.
Toxicities Measured Using CTCAE Version 4.03	4 participants with G3 TRAEs

SECONDARY outcome

Timeframe: From start of treatment until the date of death from any cause assessed up to 2 years

Outcome measures

Outcome measures
Measure	SABR + Pembrolizumab n=30 Participants SABR treatment (18Gy-20Gy/1#) followed by 200mg pembrolizumab IV once every 3 weeks for a total of 8 cycles Stereotactic Ablative Body Radiosurgery (SABR): 18-20Gy in 1 fraction 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.
Overall Survival	74 percentage of participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	SABR + Pembrolizumab n=30 Participants SABR treatment (18Gy-20Gy/1#) followed by 200mg pembrolizumab IV once every 3 weeks for a total of 8 cycles Stereotactic Ablative Body Radiosurgery (SABR): 18-20Gy in 1 fraction 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.
Freedom From Local Progression (FFLP)	92 percentage of participants Interval 80.0 to 97.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	SABR + Pembrolizumab n=30 Participants SABR treatment (18Gy-20Gy/1#) followed by 200mg pembrolizumab IV once every 3 weeks for a total of 8 cycles Stereotactic Ablative Body Radiosurgery (SABR): 18-20Gy in 1 fraction 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.
Distant Progression Free Survival (DPFS)	52 percentage of participants with DPFS Interval 33.0 to 69.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SABR + Pembrolizumab n=30 Participants SABR treatment (18Gy-20Gy/1#) followed by 200mg pembrolizumab IV once every 3 weeks for a total of 8 cycles Stereotactic Ablative Body Radiosurgery (SABR): 18-20Gy in 1 fraction 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.
Overall Response Assessed Using RECIST 1.1	63 percentage of participants Interval 44.0 to 80.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SABR + Pembrolizumab n=30 Participants SABR treatment (18Gy-20Gy/1#) followed by 200mg pembrolizumab IV once every 3 weeks for a total of 8 cycles Stereotactic Ablative Body Radiosurgery (SABR): 18-20Gy in 1 fraction 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.
Pain Assessed Using the Numerical Pain Rating Scale	22 Participants

Adverse Events

SABR + Pembrolizumab

Serious events: 4 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	SABR + Pembrolizumab n=30 participants at risk SABR treatment (18Gy-20Gy/1#) followed by 200mg pembrolizumab IV once every 3 weeks for a total of 8 cycles Stereotactic Ablative Body Radiosurgery (SABR): 18-20Gy in 1 fraction 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.
Respiratory, thoracic and mediastinal disorders respiratory	13.3% 4/30 • Up to 2 years

Other adverse events

Adverse event data not reported

Additional Information

Office of Cancer Research

Peter MacCallum Cancer Centre

Phone: +61 3 85597364

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place