Cancer of penis Cancer Malignant neoplasm of penis
Conditions
Interventions
This trial is looking at the potential benefit of cemiplimab either with standard of care (SoC) chemotherapy (Arm 1) or alone (Arm 2) in patients with locally advanced/metastatic penile carcinoma. The
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male >=18 years 2. Histologically-proven squamous cell carcinoma of the penis or penile urethra. 3. Stage: M1, or; M0,Tx,N3 (i.e. involvement of pelvic lymph nodes, or extracapsular extension in a node) or; M0,Tx,N2 (i.e. involvement of 3 or more ipsilateral inguinal lymph nodes, or to bilateral inguinal lymph nodes) and deemed inoperable by MDT, or; M0,T3,N1 (tumour invades corpus cavernosum with/ without urethral invasion or; M0,T4 (tumour invades other adjacent structures such as scrotum, prostate or pubic bone) 4. Performance Status ECOG 0, 1 or 2 5. Written, informed consent 6. Measurable disease as per RECIST 1.1 7. No previous chemotherapy for treatment of penile cancer. Patients who have had weekly cisplatin with radiotherapy (chemo-radiation) prior to advanced penile cancer diagnosis is allowed 8. Agree to use an adequate method of contraception for the course of the study and for at least 1 year after treatment has ended NB abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant. 9. Adequate organ function as evidenced by the following peripheral blood counts and serum biochemistry at enrolment: Neutrophils >=1.0 x 10^9/L Haemoglobin >=90 g/L Platelets >=100 x 10^9/L Total bilirubin <=0.5 upper limit of normal (ULN) Alanine aminotransferase transaminase (ALT) <=2.5 x ULN Serum creatinine <=1.5 x ULN.
Exclusion criteria
Exclusion criteria: 1. Pure veruccous carcinoma of the penis 2. T1 N1 M0 disease or T2 N1 M0 disease 3. Unfit for the trial regimen (as assessed by the multidisciplinary team) 4. Contraindication to chemotherapy and/or immunotherapy 5. Previous chemotherapy (except chemo-radiation) for penile cancer 6. Patients who have received radiotherapy to target lesions and have no other lesions that can act as target lesions instead (previous radiotherapy to non-target lesions is permitted) 7. ECOG Performance Status >2 8. History of an additional malignancy within 5 years of randomisation with the exception of those malignancies with a negligible risk of metastasis or death and treated with curative intent. Please confirm patient eligibility with the CI 9. Uncontrolled diabetes mellitus 10. Other concurrent serious illness or medical condition that in the investigator’s opinion precludes entry into the trial 11. History of severe hypersensitivity to another monoclonal antibody 12. History of severe hypersensitivity reaction (> = grade 3) to polysorbate 80 containing drugs 13. HIV, Hepatitis B or Hepatitis C infection 14. Active infection requiring systemic antibiotic or anti-fungal medication 15. Active or recent (within 5 years) systemic auto-immune disease requiring prolonged systemic steroids 16. Previous pneumonitis requiring systemic corticosteroid therapy 17. Interstitial lung disease 18. Receiving treatment with immunosuppressive therapy including systemic corticosteroids within 2 weeks of treatment start (Cycle 1 Day 1) 19. Treatment with systemic immunostimulatory agents (including, but not limited to, IFNs, IL-2) within 28 days or 5 half-lives of the drug, whichever is shorter, prior to treatment start (Cycle 1 Day 1) 20. Treatment with PI3K inhibitors e.g. idelalisib 21. Participation in another clinical trial with any investigational drug within 30 days prior to study registration 22. Receipt of a live virus within 28 days of randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical benefit rate (objective response rate plus stable disease) according to RECIST 1.1. criteria looking at CT scans post cycle 4 compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate safety and tolerability of study treatment including the frequency, severity and relatedness of adverse events experienced. Emergent adverse events will be assessed according to CTCAE v5.0 after each cycle from day 1 of treatment until 95 days after last treatment dose 2. Assess clinical benefit rate at 1 year, 2 years and 3 years from start of treatment 3. To assess Objective Response Rate (ORR): Proportion of patients having achieved partial or complete remission according to RECIST 1.1 post cycle 4 and when they cease treatment 4. To assess Progression-Free Survival (PFS) defined as the time from registration to the first of one of the following: development of disease progression (radiological according to RECIST 1.1) or death from any cause 5. To assess overall survival (OS) from time of registration to the date of death from any cause 6. Quality of life will be assessed using EQ-5D-5L and EORTC QLQ-C30 questionnaires at cycles 3, 5, 8, 11, 14, 17, 20, 23, 29, 32 and end of treatment visit | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed