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NCT03686332: PERICLES

PEnile Cancer Radio- and Immunotherapy CLinical Exploration Study

Completed Phase 2 Last updated 21 September 2023
What this trial tests

Phase 2 trial testing Arm A: Atezolizumab and Radiotherapy in Penile Cancer in 32 participants. Completed in 15 September 2023.

Timeline
25 September 2018
Primary endpoint
28 September 2022
15 September 2023

Quick facts

Lead sponsorThe Netherlands Cancer Institute
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment32
Start date25 September 2018
Primary completion28 September 2022
Estimated completion15 September 2023
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

The Netherlands Cancer Institute

Who can join

18 and older, male only, with Penile Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with advanced penile cancer have a poor prognosis (21% 2-year overall survival from moment of diagnosis) and high morbidity due to progressive locoregional disease. Translational studies show high rates of infiltrating immune cells and PD-L1 positivity, suggesting that immunotherapy may be beneficial in this disease. Atezolizumab, targeting PD-L1, is active in several cancer types and is generally well-tolerated. This study will investigate whether atezolizumab can be combined with radiotherapy to control locoregional lymph node disease. Furthermore, the activity of atezolizumab in advanced penile cancer patients will be investigated.

Publications & conference data

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

  1. A global approach to improving penile cancer care.
    Bandini M, Ahmed M, Basile G, Watkin N, et al · · 2022 · cited 45× · PMID 34937881 · DOI 10.1038/s41585-021-00557-y
  2. Pembrolizumab for advanced penile cancer: a case series from a phase II basket trial.
    Hahn AW, Chahoud J, Campbell MT, Karp DD, et al · · 2021 · cited 45× · PMID 33770291 · DOI 10.1007/s10637-021-01100-x
  3. An update on treatment of penile cancer.
    Chadha J, Chahoud J, Spiess PE. · · 2022 · cited 35× · PMID 36172172 · DOI 10.1177/17588359221127254
  4. Recent Advances in the Management of Penile Cancer: A Contemporary Review of the Literature.
    Stecca CE, Alt M, Jiang DM, Chung P, et al · · 2021 · cited 31× · PMID 33454930 · DOI 10.1007/s40487-020-00135-z
  5. The combination of immune checkpoint inhibitors and antibody-drug conjugates in the treatment of urogenital tumors: a review insights from phase 2 and 3 studies.
    Yu P, Zhu C, You X, Gu W, et al · · 2024 · cited 28× · PMID 38898003 · DOI 10.1038/s41419-024-06837-w
  6. The Immune Microenvironment in Penile Cancer and Rationale for Immunotherapy.
    Ahmed ME, Falasiri S, Hajiran A, Chahoud J, et al · · 2020 · cited 28× · PMID 33080912 · DOI 10.3390/jcm9103334
  7. Immune landscape and immunotherapy for penile cancer.
    Tang Y, Hu X, Wu K, Li X. · · 2022 · cited 23× · PMID 36524123 · DOI 10.3389/fimmu.2022.1055235
  8. Penile cancer: Updates in systemic therapy.
    Joshi VB, Chadha J, Chahoud J. · · 2022 · cited 17× · PMID 36381603 · DOI 10.1016/j.ajur.2022.03.006

Verify or expand the search:

Other recruiting trials for Penile Cancer

Currently open trials in the same condition.

Other The Netherlands Cancer Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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