NCT02826564

Trial of Stereotactic Body Radiotherapy With Concurrent Pembrolizumab in Metastatic Urothelial Cancer

Completed Phase 1 Last updated 17 July 2024

What this trial tests

Phase 1 trial testing pembrolizumab in Metastatic Urothelial Cancer in 18 participants. Completed in 18 February 2019.

Timeline

14 November 2016

Primary endpoint
2 April 2018

18 February 2019

Quick facts

Lead sponsor	University Hospital, Ghent
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	14 November 2016
Primary completion	2 April 2018
Estimated completion	18 February 2019
Sites	1 location across Belgium

Drugs / interventions tested

• pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

• Metastatic Urothelial Cancer — all drugs for Metastatic Urothelial Cancer →

Sponsor

University Hospital, Ghent

Who can join

18 and older, any sex, with Metastatic Urothelial Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of the proposed research project is to assess the safety (dose limiting toxicity, DLT) of the combination of pembrolizumab and high-dose stereotactic body radiotherapy (SBRT) in patients with metastatic urothelial cancer. Both the SBRT dose and pembrolizumab dose will be fixed, but the timing of the combination will be varied. Secondary objectives include response rates, local control, progression-free survival (PFS) and overall survival (OS). Exploratory endpoints include immunologic responses and response rates in PD-L1- TIL- tumors. The combination sequence with the most promising response rates and the best safety profile will be selected to continue in a Phase II trial.

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. Novel Approaches to Improve the Efficacy of Immuno-Radiotherapy.
   Shevtsov M, Sato H, Multhoff G, Shibata A. · · 2019 · cited 137× · PMID 30941308 · DOI 10.3389/fonc.2019.00156
3. Radiomics to predict outcomes and abscopal response of patients with cancer treated with immunotherapy combined with radiotherapy using a validated signature of CD8 cells.
   Sun R, Sundahl N, Hecht M, Putz F, et al · · 2020 · cited 67× · PMID 33188037 · DOI 10.1136/jitc-2020-001429
4. Trial watch: Immune checkpoint blockers for cancer therapy.
   Vanpouille-Box C, Lhuillier C, Bezu L, Aranda F, et al · · 2017 · cited 55× · PMID 29147629 · DOI 10.1080/2162402x.2017.1373237
5. Optimizing the Treatment Schedule of Radiotherapy Combined With Anti-PD-1/PD-L1 Immunotherapy in Metastatic Cancers.
   Kong Y, Ma Y, Zhao X, Pan J, et al · · 2021 · cited 34× · PMID 33859942 · DOI 10.3389/fonc.2021.638873
6. 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
7. A phase I/II trial of fixed-dose stereotactic body radiotherapy with sequential or concurrent pembrolizumab in metastatic urothelial carcinoma: evaluation of safety and clinical and immunologic response.
   Sundahl N, De Wolf K, Rottey S, Decaestecker K, et al · · 2017 · cited 23× · PMID 28662677 · DOI 10.1186/s12967-017-1251-3
8. Beyond success: unveiling the hidden potential of radiotherapy and immunotherapy in solid tumors.
   Wu Y, Yi M, Niu M, Zhou B, et al · · 2024 · cited 14× · PMID 38837878 · DOI 10.1002/cac2.12576