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CTRI Number  CTRI/2025/11/097637 [Registered on: 18/11/2025] Trial Registered Prospectively
Last Modified On: 16/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Immunotherapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   "A study testing if adding tablets and a small dose of immunotherapy to standard chemotherapy makes treatment more effective for men with penile cancer before surgery." 
Scientific Title of Study   A Phase II Randomized Trial of Neoadjuvant Chemotherapy With or Without Triple Oral Metronomic Chemotherapy and Low-Dose Immunotherapy in Resectable Locally Advanced Penile Squamous Cell Carcinoma 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Minit Shah  
Designation  Associate Professor, Medical Oncology  
Affiliation  Tata Memorial Hospital 
Address  Room No 1006,10 floor, Homi bhabha Block,Tata Memorial hospital, Dr. E Borges Marg, Parel, Mumbai Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9892640668  
Fax    
Email  minitjshah@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Minit Shah  
Designation  Associate Professor, Medical Oncology  
Affiliation  Tata Memorial Hospital 
Address  Room No 1006,10 floor, Homi bhabha Block,Tata Memorial hospital, Dr. E Borges Marg, Parel, Mumbai Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9892640668  
Fax    
Email  minitjshah@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Minit Shah  
Designation  Associate Professor, Medical Oncology  
Affiliation  Tata Memorial Hospital 
Address  Room No 1006,10 floor, Homi bhabha Block,Tata Memorial hospital, Dr. E Borges Marg, Parel, Mumbai Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9892640668  
Fax    
Email  minitjshah@gmail.com  
 
Source of Monetary or Material Support  
This is academic trial & currently no funding from anywhere else.  
 
Primary Sponsor  
Name  Tata Memorial Hospital  
Address  Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai 400012  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gaurav Kumar  Homi Bhabha Cancer Hospital and Research Centre  Department of Medical Oncology, Room no 108, HBCH & RC, SKMCH Campus, Uma Nagar, Rasulpur, Muzaffarpur 842004 Muzaffarpur BIHAR
Muzaffarpur
BIHAR 		 9264493969

gaurav_crj@rediffmail.com 
Dr Minit Shah  TMH ACTREC  Room No 1006 10 floor Homi bhabha Block Tata Memorial hospital Dr E Borges Marg Parel Mumbai Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 		 09892640668

minitjshah@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N489||Disorder of penis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Neoadjuvant 2-drug or 3-drug chemotherapy  1. Paclitaxel and Platinum (Cisplatin/Carboplatin) doublet administered in every weekly or every 3-weekly schedule, a. Paclitaxel will be dosed at 80 mg/m2 given intravenous on Day 1 when administered once weekly OR 175 mg/m2 given intravenous on Day 1 when administered in once every 3-weekly schedule b. Carboplatin AUC 2 (calculated by Calvert formula) will be administered intravenous, in 250-500ml 0.9%NS or dextrose solutions over 30-60mins on Day 1 when administered once weekly OR AUC 5 or 6 when administered in once every 3-weekly schedule c. Cisplatin will be dosed at 75 mg/m2 given intravenous on Day 1 (or split dosing as per discretion of the treating physician) when administered in once every 3-weekly schedule. d. When the paclitaxel and carboplatin doublet are administered in weekly schedule, a total of 6-8 cycles will be given. Additional weekly cycles will be subject to the discretion of the treating physician (max 12 cycles). e. When the paclitaxel and platinum (cisplatin/carboplatin) doublet are administered in every 3-weekly schedule, a total of 3-4 cycles will be given. Additional cycles will be subject to the discretion of the treating physician (max 6 cycles). 2. Paclitaxel, Platinum (Cisplatin OR Carboplatin), and Ifosfamide triplet administered in every 3-weekly schedule, a. Paclitaxel will be dosed at 175 mg/m2 given intravenous on Day 1 administered in once every 3-weekly schedule b. Ifosfamide will be dosed at1200 mg/m2, Intravenous, on Days 1–3, administered in once every 3-weekly schedule c. Cisplatin will be dosed at 25 mg/m2 given intravenous on Day 1-3 administered in once every 3-weekly schedule.OR d. CarboplatinAUC 5 or 6, Intravenous, in 250-500ml 0.9%NS or dextrose solutions over 30-60mins, administered in once every 3-weekly schedule A total of 3-4 cycles of TIP chemotherapy will be delivered.  
Intervention  Neoadjuvant chemotherapy plus triple-OMCT plus low-dose nivolumab  Neoadjuvant intravenous weekly paclitaxel 80mg/m2 plus intravenous carboplatin AUC-2 plus triple-oral metronomic chemotherapy (tablet methotrexate 9mg/m2 orally once a week, tablet erlotinib 150mg orally once daily, capsule celecoxib 200mg orally twice daily) plus intravenous low-dose Nivolumab 40mg every 3-weekly. 8 (max12) cycles of weekly paclitaxel carboplatin, triple-oral metronomic chemotherapy, and 3-4 cycles of low-dose nivolumab will be administered as neoadjuvant therapy. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pathological complete response rate (pCR)  4 years 
 
Secondary Outcome  
Outcome  TimePoints 
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 rates  4 years 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Aim: To evaluate the efficacy and impact on survival with neoadjuvant chemotherapy with or without triple oral metronomic chemotherapy and low-dose immunotherapy in resectablelocally advanced penile squamous cell carcinoma

Primary Objective:Pathological complete response rate (pCR)

Secondary Objectives: 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 rates

Tertiary Objectives:Exploring biomarkers

Treatment Plan:Eligible patients will be randomized in a 1:1 manner to doublet neoadjuvant chemotherapy (Paclitaxel, Carboplatin) plus triple oral metronomic chemotherapy (methotrexate, erlotinib, celecoxib), and low-dose immunotherapy (nivolumab) or neoadjuvant doublet or triplet chemotherapy (taxane and platinum, or taxane, platinum, and ifosfamide) alone. Patients will be assessed for definitive therapy (surgery and/or radiation) after completion of neoadjuvant therapy. After definitive therapy, patients will be followed-up every 2-3 months until progressive disease or unacceptable treatment related toxicity. Following progression or discontinuation, patients will be followed up and treated as per the discretion of the treating physician or as per standard institutional protocol.

Interim analysis (If recommended by the ethics committee):A single interim analysis will be conducted after ~50 patients have evaluable pCR data. Early stopping for efficacy will be considered if the one-sided p value is less than or  equal to 0.005. Futility will be declared if conditional power is less than 20% under both planned and observed assumptions (or is less than or  equal to 10% under observed trend). The trial may be paused/stopped for safety if the absolute increase in grade is more than or  equal to3 AE rate in Arm A vs Arm B exceeds 25 percentage points and is judged clinically unacceptable.


 
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