Health Condition 1: N489- Disorder of penis, unspecified
Conditions
Interventions
Intervention1: Neoadjuvant chemotherapy plus triple-OMCT plus low-dose nivolumab: Neoadjuvant intravenous weekly paclitaxel 80mg/m2 plus intravenous carboplatin AUC-2 plus triple-oral metronomic chemo
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must be treatment naïve and have histologically proven squamous cell carcinoma of the penis. The tumour should be surgically resectable, and patients referred for neoadjuvant treatment after a multidisciplinary joint clinic decision will be included. Prior local treatment for the primary tumour will be permitted if deemed appropriate by the multidisciplinary team. Male or transgender subjects aged 18 years and above. Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2. Subjects must have normal organ and marrow function and all the counts are in the normal range Patients with HIV are eligible if their CD4 count is above 200, they are on HAART therapy, and there are no active AIDS-defining conditions. Subjects must agree to use effective contraception during the study and for three months after completion of treatment. Men of all races and ethnic groups are eligible for this study. Ability to understand and willingness to sign a written informed consent document. Subjects must agree to use highly effective contraception throughout the study and for at least 30 days after the last dose of Nivolumab, as the drug may be harmful to a developing foetus. Willingness to comply with all study requirements and procedures.
Exclusion criteria
Exclusion criteria: Subjects who are receiving any other investigational agents. Presence of clinical or radiological evidence of metastatic disease. Patients who are unfit for curative surgery for any reason. Active infection requiring systemic therapy. Hepatitis B or C infection at screening with a raised viral load (HBV DNA or HCV RNA). Known severe hypersensitivity to the study drug or its components. Clinically significant cardiovascular disease such as unstable angina, congestive heart failure of New York Heart Association Class II or higher, serious uncontrolled arrhythmia, or an ejection fraction less than 50 percent. Presence of severe acute or chronic medical or psychiatric conditions such as inflammatory bowel disease, pneumonitis, chronic kidney disease, chronic liver disease, pulmonary fibrosis, peripheral neuropathy of grade more than one, or active suicidal ideation or behaviour. History of any other malignancy within the past three years except curatively treated basal cell carcinoma of the skin. Current use of immunosuppressive medication except for local, inhaled, or topical steroids, systemic corticosteroids at physiologic doses of ten milligrams or less of prednisone or equivalent, steroids as premedication for scans or emesis, or steroids used for raised intracranial pressure due to disease. Active autoimmune disease that could worsen with chemotherapy. Patients with type 1 diabetes, vitiligo, psoriasis, or thyroid disorders not requiring immunosuppressive treatment are eligible. History of organ or allogeneic stem-cell transplantation. Vaccination within four weeks prior to the first dose of Nivolumab and during the study period, except for administration of inactivated vaccines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate (pCR)Timepoint: 4 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Event free survival (EFS), Overall Survival (OS), Lymph node pathological complete response rate, Patterns of treatment failure, Quality of Life (QOL), Safety, Treatment completion rates, Objective Response Rate (ORR), R0 resection rates, Postoperative complication ratesTimepoint: 4 years | — |
Countries
India
Contacts
Public ContactDr Minit Shah
Tata Memorial Hospital
Outcome results
None listed