NCT02560636: PLUMMB

Pembrolizumab in Muscle Invasive/Metastatic Bladder Cancer

Active, enrolled Phase 1 Last updated 6 January 2026

What this trial tests

Phase 1 trial testing Pembrolizumab in Invasive Bladder Cancer in 34 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 June 2016

Primary endpoint
15 January 2025

30 July 2028

Quick facts

Lead sponsor	Royal Marsden NHS Foundation Trust
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	34
Start date	6 June 2016
Primary completion	15 January 2025
Estimated completion	30 July 2028
Sites	1 location across United Kingdom

Drugs / interventions tested

• Pembrolizumab (pembrolizumab) — full drug profile →
• Radiotherapy — full drug profile →

Conditions studied

• Invasive Bladder Cancer — all drugs for Invasive Bladder Cancer →

Sponsor

Royal Marsden NHS Foundation Trust

Who can join

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

Sponsor's own description

PLUMMB is an phase I trial to investigate the safety, tolerability and effectiveness of an immunotherapy drug called Pembrolizumab used in combination with radiotherapy. The study will also investigate two different doses of pembrolizumab, starting at 100mg (through an intravenous drip) and increasing to 200mg for the next cohort of patients, if the first dose is well tolerated. The patients suitable for this study will be: Group A those with locally advanced bladder cancer or Group B patients whose cancer has spread from the bladder (metastatic bladder cancer).

Treatment in the PLUMMB trial will start with a pembrolizumab 2 weeks prior to starting a course of 4 - 6 weeks radiotherapy. Treatment with pembrolizumab will then be given every three weeks. Patients in Group A will then continue to take pembrolizumab for up to a year unless they have disease progression or unacceptable side effects in the meantime. Patients in Group B will continue taking pembrolizumab for as long as needed until they have disease progression or unacceptable side effects.

Patients will be seen every 3 weeks during treatment and every 3-6 months thereafter. CT scans will be done every 3 months during treatment and as per usual care (usually 6 monthly) after the treatment has finished. Patients in Group A will also have a cystoscopy (camera test) to look into the bladder 3 months after they finish radiotherapy. This is standard care and would be the same for patients not on a research study.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current clinical trials testing the combination of immunotherapy with radiotherapy.
   Kang J, Demaria S, Formenti S. · · 2016 · cited 293× · PMID 27660705 · DOI 10.1186/s40425-016-0156-7
2. The Abscopal Effect: A Review of Pre-Clinical and Clinical Advances.
   Janopaul-Naylor JR, Shen Y, Qian DC, Buchwald ZS. · · 2021 · cited 118× · PMID 34681719 · DOI 10.3390/ijms222011061
3. FLASH X-ray spares intestinal crypts from pyroptosis initiated by cGAS-STING activation upon radioimmunotherapy.
   Shi X, Yang Y, Zhang W, Wang J, et al · · 2022 · cited 79× · PMID 36256824 · DOI 10.1073/pnas.2208506119
4. Dose-limiting Urinary Toxicity With Pembrolizumab Combined With Weekly Hypofractionated Radiation Therapy in Bladder Cancer.
   Tree AC, Jones K, Hafeez S, Sharabiani MTA, et al · · 2018 · cited 73× · PMID 30012528 · DOI 10.1016/j.ijrobp.2018.04.070
5. Trial Watch: Immunotherapy plus radiation therapy for oncological indications.
   Vacchelli E, Bloy N, Aranda F, Buqué A, et al · · 2016 · cited 61× · PMID 27757313 · DOI 10.1080/2162402x.2016.1214790
6. Targeting Myeloid-Derived Suppressor Cells in Cancer Immunotherapy.
   Wang Y, Jia A, Bi Y, Wang Y, et al · · 2020 · cited 45× · PMID 32942545 · DOI 10.3390/cancers12092626
7. Combined radiotherapy and immunotherapy in urothelial bladder cancer: harnessing the full potential of the anti-tumor immune response.
   Daro-Faye M, Kassouf W, Souhami L, Marcq G, et al · · 2021 · cited 45× · PMID 32915313 · DOI 10.1007/s00345-020-03440-4
8. Improving Anti-PD-1/PD-L1 Therapy for Localized Bladder Cancer.
   de Jong FC, Rutten VC, Zuiverloon TCM, Theodorescu D. · · 2021 · cited 40× · PMID 33802033 · DOI 10.3390/ijms22062800