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NCT02855203: RAPPORT

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

Completed Phase 1, PHASE2 Results posted Last updated 3 August 2023
What this trial tests

Phase 1, PHASE2 trial testing Stereotactic Ablative Body Radiosurgery (SABR) in Renal Cell Carcinoma in 30 participants. Completed in 22 May 2020.

Timeline
20 October 2016
Primary endpoint
22 May 2020
22 May 2020

Quick facts

Lead sponsorPeter MacCallum Cancer Centre, Australia
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date20 October 2016
Primary completion22 May 2020
Estimated completion22 May 2020
Sites2 locations across Australia

Drugs / interventions tested

Conditions studied

Sponsor

Peter MacCallum Cancer Centre, Australia — full company profile →

Who can join

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 4.03 Primary · 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.

GroupValue95% CI
SABR + Pembrolizumab4
Overall Survival Secondary · From start of treatment until the date of death from any cause assessed up to 2 years
GroupValue95% CI
SABR + Pembrolizumab74
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

GroupValue95% CI
SABR + Pembrolizumab9280 – 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)

GroupValue95% CI
SABR + Pembrolizumab5233 – 69
Overall Response Assessed Using RECIST 1.1 Secondary · 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.

GroupValue95% CI
SABR + Pembrolizumab6344 – 80
Pain Assessed Using the Numerical Pain Rating Scale Secondary · 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.

GroupValue95% CI
SABR + Pembrolizumab22

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.

SABR + Pembrolizumab
Serious: 4/30 (13%)
Deaths: 7/30

Serious adverse events (1 terms)

ReactionSystemSABR + Pembrolizumab
respiratoryRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: respiratory.

Data from ClinicalTrials.gov NCT02855203 adverse events section.

Sponsor's own description

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):

  1. Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
    Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2
  2. Definitive radiotherapy in lieu of systemic therapy for oligometastatic renal cell carcinoma: a single-arm, single-centre, feasibility, phase 2 trial.
    Tang C, Msaouel P, Hara K, Choi H, et al · · 2021 · cited 126× · PMID 34717797 · DOI 10.1016/s1470-2045(21)00528-3
  3. Stereotactic Radiotherapy and Short-course Pembrolizumab for Oligometastatic Renal Cell Carcinoma-The RAPPORT Trial.
    Siva S, Bressel M, Wood ST, Shaw MG, et al · · 2022 · cited 106× · PMID 34953600 · DOI 10.1016/j.eururo.2021.12.006
  4. Overcoming cold tumors: a combination strategy of immune checkpoint inhibitors.
    Ouyang P, Wang L, Wu J, Tian Y, et al · · 2024 · cited 66× · PMID 38545114 · DOI 10.3389/fimmu.2024.1344272
  5. Radiotherapy induced immunogenic cell death by remodeling tumor immune microenvironment.
    Zhu S, Wang Y, Tang J, Cao M. · · 2022 · cited 60× · PMID 36532071 · DOI 10.3389/fimmu.2022.1074477
  6. PD1/PD-L1 blockade in clear cell renal cell carcinoma: mechanistic insights, clinical efficacy, and future perspectives.
    Zhu Z, Jin Y, Zhou J, Chen F, et al · · 2024 · cited 45× · PMID 39014460 · DOI 10.1186/s12943-024-02059-y
  7. Is there a role for stereotactic radiotherapy in the treatment of renal cell carcinoma?
    Rühle A, Andratschke N, Siva S, Guckenberger M. · · 2019 · cited 30× · PMID 31341985 · DOI 10.1016/j.ctro.2019.04.012
  8. Combination therapy with PD-1/PD-L1 blockade: An overview of ongoing clinical trials.
    Johnson CB, Win SY. · · 2018 · cited 26× · PMID 29632719 · DOI 10.1080/2162402x.2017.1408744

Verify or expand the search:

Other recruiting trials for Renal Cell Carcinoma

Currently open trials in the same condition.

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