Penile cancer
Conditions
Interventions
All patients will receive atezolizumab, 1200 mg, every 3 weeks, by IV infusion.
Patients in group A will additionally receive 33 fractions of 1.5 or 1.8 Gy
irradiation on locoregional affected lymph
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 18 years at time of study entry., - Advanced histologically documented, squamous cell carcinoma of the penis or distal urethra. Advanced disease is defined as:, -Distant metastases, OR, -LRAPC, defined as a large or inoperable primary tumor (T4), palpable nodes >3cm in diameter or fixed nodes, suspicion of extra-nodal extension or pelvic node involvement (N2/N3), Arm A: Locoregional disease (with or without distant metastases), likely to derive benefit from locoregional radiotherapy and not previously treated with radiotherapy., Arm B: Benefit of locoregional radiotherapy unlikely OR previously treated with irradiation. , Adequate normal organ and marrow function as defined below: , -Haemoglobin >= 5.6/mmol/L, -White blood cell count (WBC) >= 2 x 109/L (> 1500 per mm3), -Absolute neutrophil count (ANC) >= 1.5 x 109/L (> 1500 per mm3), -Platelet count >= 100 x 109/L (>100,000 per mm3), -Serum bilirubin
Exclusion criteria
Exclusion criteria: 1. Involvement in the planning and/or conduct of the study (applies to both Roche staff and/or staff at the study site). Previous enrolment in the present study., 2. Participation in another clinical study with an investigational product during the last 4 weeks, 3. Any previous treatment with a PD1 or PD-L1 inhibitor, 4. History of another primary malignancy except for:, •Malignancy treated with curative intent and with no known active disease >=2 years before the first dose of study drug, •Low potential risk of 3-year cancer-specific death (estimated<5%), including adequately treated non-melanoma skin cancer without evidence of disease, adequately treated carcinoma in situ without evidence of disease, or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer (Gleason score =*28 days after completion of treatment (including surgery, radiotherapy or treatment with systemic corticosteroids). , 12. Subjects with uncontrolled seizures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) at 1 year after initiation of treatment. A PFS event is defined as RECIST 1.1 progressive disease (appearance of new lesions or progression of existing target/nontarget lesions) or death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Overall Survival (OS) rate at 2 years in the full study population - Feasibility of combining immunotherapy with radiotherapy as measured by number of patients who complete the combined modality treatment (Arm A). Completion is defined as having received at least 90% of planned radiation doses. - Locoregional Recurrence-free survival in patients treated with the combination of radiotherapy and atezolizumab (arm A) - Response rate for patients with measurable disease - Median PFS (as measured by RECIST 1.1) and OS for the full study cohort (Arm A+B) - 2-year PFS (as measured by RECIST 1.1) and OS for PD-L1-positive patients in the full study cohort (Arm A+B) - Toxicity by CTCAE-NCI V4 in the combined modality arm | — |
Countries
Netherlands
Outcome results
None listed