PEnile Cancer Radio- and Immunotherapy CLinical Exploration Study

Sponsor
The Netherlands Cancer Institute
Study ID
NCT03686332
Phase
PHASE2
Status
Completed

Conditions

  • Penile Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Arm A: Atezolizumab and Radiotherapy — DRUG
    patients will receive atezolizumab, 1200 mg, every 3 weeks, by IV infusion. Patients in group A will additionally receive 33 fractions of 1.5 (locoregional affected lymph nodes) and 1.8 Gy (tumor+margin) irradiation, concurrently with atezolizumab treatment.
  • Arm B: Atezolizumab — DRUG
    patients will receive atezolizumab, 1200 mg, every 3 weeks, by IV infusion.

Study Details

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.

Key Dates

Start date
Sep 25, 2018
Status verified
Sep 2023
Primary completion
Sep 28, 2022
Completion
Sep 15, 2023

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Arm A: Atezolizumab and Radiotherapy
    Patients in this group will concurrently be treated with locoregional radiotherapy and atezolizumab. Drug: Arm A: Atezolizumab and Radiotherapy Atezolizumab, 1200 mg, every 3 weeks, by IV infusion and receive 33 fractions of 1.5 or 1.8 Gy irradiation.
  • Other: Arm B: Atezolizumab
    Atezolizumab, 1200 mg, every 3 weeks, by IV infusion.

Primary Outcome Measure

Progression-free survival at 1 year. [ Time Frame: 1 year ]

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