A trial for men with advanced penile cancer to see if immunotherapy is an effective treatment either given on its own or at the same time as chemotherapy

Phase 2

• Conditions: Cancer of penis; Cancer; Malignant neoplasm of penis

• Registration Number: ISRCTN95561634
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-30
• Last Update Posted: 12 April 2021
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 47

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified