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CTRI Number  CTRI/2026/02/105089 [Registered on: 27/02/2026] Trial Registered Prospectively
Last Modified On: 19/08/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study in patients with advanced head and neck cancer comparing tablet based chemotherapy plus low dose immunotherapy with standard IV chemotherapy to evaluate effectiveness and side effects. 
Scientific Title of Study   Triple Oral Metronomic Chemotherapy with Paclitaxel and Carboplatin plus Low Dose Nivolumab: First-line Immunotherapy and Repurposed- drug combination — A Phase III Randomized Controlled Trial in Platinum- Sensitive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4898 Version 3.0 dated 1 Jan 2026  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vanita Noronha  
Designation  Medical Oncologist  
Affiliation  Tata Memorial Hospital 
Address  Tata Memorial Hospital, Department of Medical Oncology , OPD NO 204, 2nd floor Hoi Bhabha Block,Dr E Borges Marg Parel Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9769328047  
Fax    
Email  vanita.noronha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vanita Noronha  
Designation  Medical Oncologist  
Affiliation  Tata Memorial Hospital 
Address  Tata Memorial Hospital, Department of Medical Oncology , OPD NO 204, 2nd floor Hoi Bhabha Block,Dr E Borges Marg Parel Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9769328047  
Fax    
Email  vanita.noronha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kavita Nawale 
Designation  Project Manager 
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Hospital, Department of Medical Oncology , OPD NO 204, 2nd floor Hoi Bhabha Block,Dr E Borges Marg Parel Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  89369874645  
Fax    
Email  kavitatmh@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr E Borges road, parel, Mumbai-400012 
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai-400012 
Type of Sponsor  Other [[Government Hospital ]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gaurav Kumar  Homi Bhabha Cancer Hospital and Research Centre, Muzaffarpur  Department of Medical Oncology, Room no 108, HBCH & RC, SKMCH Campus, Uma Nagar, Rasulpur, Muzaffarpur 842004
Muzaffarpur
BIHAR 		 9264493969

kumarg@hbchrcmzp.tmc.gov.in 
Dr Akhil Kapoor  Mahamana Pandit Madan Mohan Malaviya Cancer centre  Department of Medical Oncology OPD No 28 Ground floor DNT Block Sundar Bagiya Near Nariya Gate Banaras Hindu University Campus 221005
Varanasi
UTTAR PRADESH 		 7597364554

kapoorakhil1987@gmail.com 
Dr Vanita Noronha  Tata Memorial Centre  Tata Memorial Hospital, Department of Medical Oncology , OPD NO 204, 2nd floor Hoi Bhabha Block,Dr E Borges Marg Parel Mumbai 400012
Mumbai
MAHARASHTRA 		 97693280047

vanita.noronha@gmail.com 
Dr Yashwant Kashyap  Vedanta Medical Research Foundation  BALCO Medical Centre Ground Floor A wing Room no 02 Department ofMedical Oncology
Raipur
CHHATTISGARH 		 7408564918

Yashwant.Kashyap@vedanta.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee - I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Paclitaxel, Carboplatin  Paclitaxel 175 mg per m IV Day 1 and Carboplatin AUC 6 IV Day 1 administered once every 21 days .Cycles will be administered every 21 days for up to 4-6 cycles. In patients who are tolerating the therapy well and appear to have ongoing clinical benefit the treatment may be continued beyond 6 cycles at the discretion of the treating physician, until disease progression or toxicity 
Intervention  Paclitaxel, Carboplatin, Methotrexate, Celecoxib, Erlotinib, Nivolumab  Paclitaxel 80 mg/m² IV weekly + Carboplatin AUC 2 IV weekly + Methotrexate 9 mg/m² orally once weekly + Celecoxib 200 mg orally twice daily + Erlotinib 150 mg orally once daily + Nivolumab 40 mg IV every 3 weeks .Following 4 months of therapy roughly equivalent to 4-6 cycles of 3 weekly chemotherapy, the treating physician has the option to stop the weekly paclitaxel and carboplatin and continue the TMCI. For patients who are tolerating the regimen well, weekly paclitaxel and carboplatin may be continued along with TMCI until progression or unacceptable toxicity, at the discretion of the treating physician 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Age greater than equal to 18 years
2.Histologically or cytologically confirmed squamous cell carcinoma of the head and neck oral cavity, oropharynx, larynx, hypopharynx, carcinoma of unknown primary in cervical lymph nodes
3.Locally advanced or recurrent or metastatic disease not amenable to curative therapy
4.Platinum sensitive recurrence greater than equal to 3 months from last platinum dose
5.ECOG performance status 0 to 2
6.Adequate organ function
7.Signed informed consent
 
 
ExclusionCriteria 
Details  1.Nasopharyngeal carcinoma
2.Salivary gland tumours
3.Active autoimmune disease requiring systemic treatment
4.Prior treatment with anti PD 1, PD L1, or CTLA4 inhibitors
5.Uncontrolled infections or comorbidities
6.Pregnant or breastfeeding women
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Overall Survival (OS)  Time from date of randomization to death from any cause. Patients lost to follow-up or alive at the time of analysis will be censored on the date of last contact. 
 
Secondary Outcome  
Outcome  TimePoints 
Progression-Free Survival (PFS)  every 8–12 weeks (as per institutional practice) Until progression  
Objective Response Rate (ORR)  First radiological assessment at approximately 8–12 weeks 
Disease Control Rate (DCR)  Proportion of patients achieving CR, PR, or stable disease (SD) for greater than equal to 6 weeks.At first response evaluation (~8–12 weeks) 
Time to Treatment Failure (TTF)  During treatment every weekly or 3 weekly as per protocol 
Adverse Events (Toxicity)  During treatment every weekly or 3 weekly as per protocol 
Quality of Life (QoL)  Baseline, weekly or 3 weekly and after completion of treatment and at follow up 
Treatment Compliance  During treatment every 3 weekly 
 
Target Sample Size   Total Sample Size="436"
Sample Size from India="436" 
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 3 
Date of First Enrollment (India)   02/03/2026 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Head and neck squamous cell carcinoma (HNSCC), especially oral cancer, is a major health burden in India. Standard chemotherapy regimens like cisplatin + 5FU (EXTREME) or immunotherapy (KEYNOTE-048) have shown modest survival benefits, but are often not affordable for most patients. Less than 3% of eligible patients in India can access immunotherapy due to its high cost.

 

To address this challenge, this study evaluates combining weekly paclitaxel + carboplatin with triple oral metronomic chemotherapy (methotrexate, celecoxib, erlotinib) and low-dose nivolumab — known as the PCm-IO regimen. This is a Phase III, multicenter, open-label randomized controlled trial comparing the PCm-IO regimen with standard 3-weekly paclitaxel-carboplatin chemotherapy in the first-line palliative setting for patients with platinum-sensitive advanced or metastatic HNSCC. Around 436 participants will be enrolled based on defined inclusion and exclusion criteria.

 

The study aims to evaluate whether the PCm-IO regimen is non-inferior or superior to standard treatment in terms of overall survival (OS), progression-free survival (PFS), response rate, toxicity, and quality of life. The treatment period is approximately 4-6 months, followed by regular follow-ups until disease progression or unacceptable toxicity. The total study duration is expected to be 5 years.

 

 
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