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CTRI Number  CTRI/2025/10/095871 [Registered on: 10/10/2025] Trial Registered Prospectively
Last Modified On: 10/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Study to Identify Biological Markers Linked to Immunotherapy Response in Indian Oral Cancer Patients 
Scientific Title of Study   Identifying Omics-based biomarkers for immunotherapy response in Indian oral cancer: A prospective study. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
4779  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kumar Prabhash 
Designation  Professor and Head Solid Unit 
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Centre, OPD No 204 ,2nd Floor , Homi Bhabha Block,Medical Oncology Department , Dr E Borges road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177214  
Fax  91-22-24171734  
Email  kprabhash1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kumar Prabhash 
Designation  Professor and Head Solid Unit 
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Centre, OPD No 204 ,2nd Floor , Homi Bhabha Block,Medical Oncology Department , Dr E Borges road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177214  
Fax  91-22-24171734  
Email  kprabhash1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kavita Nawale 
Designation  Project Manager 
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Centre, OPD No 204 ,2nd Floor , Homi Bhabha Block,Medical Oncology Department , Dr E Borges road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224176214  
Fax    
Email  kavitatmh@gmail.com  
 
Source of Monetary or Material Support  
Tata Trust,Bombay House, 24, Homi Modi St, Kala Ghoda, Fort, Mumbai, Maharashtra 400001 
 
Primary Sponsor  
Name  TATA Trust India 
Address  Bombay House, 24, Homi Modi St, Kala Ghoda, Fort, Mumbai, Maharashtra 400001 
Type of Sponsor  Other [Private fuding agency ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nidhan Biswas  BRIC-National Institute of Biomedical Genomics  BRIC-National Institute of Biomedical Genomics, Near Netaji Subhas Sanatorium Post Office, Kulia Rd, Block A, Kalyani, West Bengal 741251
Nadia
WEST BENGAL 		 8240597515

nkb1@nibmg.ac.in 
Dr Kumar Prabhash  Tata Memorial Hospital  OPD No 204, 2nd Floor Homi Bhabha Block , Medical oncology deaprtment, Tata Memorial Hospital,Dr E Borges road, Parel
Mumbai
MAHARASHTRA 		 02224176214

kprabhash1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee- I  Approved 
NIBMGEthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Subjects must have T3 N1-N3 or T4 HNSCC of the oral cavity who has received immunotherapy in either the palliative or adjuvant treatment setting.

2. Age: Male or female or transgender subjects aged more than or equal to 18 years.

3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.

4. Subjects must have normal organ and marrow function as per institute protocols

5. Patients with HIV will be potentially eligible, as long as they have a CD4 count less than 200, are on concurrent HAART (highly active antiretroviral therapy), and have absence of active AIDS defining conditions.

6. Both men and women of all races and ethnic groups will be eligible for this study.

7. Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals and/or nature of required assessments.

8. Ability to understand and the willingness to sign a written informed consent document. 
 
ExclusionCriteria 
Details  1. Subjects who are receiving any other investigational agents.

2. Within 2 weeks of administration of a chemotherapeutic agent.

3. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses less than or equal to 10 mg per day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) d. Steroids for raised intracranial pressure due to the disease itself e,Steroid use for avoidance or treatment of emesis

4. Uncontrolled comorbidities including active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent. Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke (less than 6 months prior to enrollment), myocardial infarction (less than 6 months prior to enrollment), unstable angina, congestive heart failure (more than or equal to New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. Patients with severe renal and liver dysfunction Child Pugh B or C.

5. Prior organ transplantation including allogeneic stem-cell transplantation.

6. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE v5.0 Grade more than or equal to 3).

7. Pregnant and lactating women will be excluded from this study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To identify the molecular genomic alterations in Indian immuno+chemotherapy-treated OSCC patients .
2. To identify the molecular marker alteration profile differentiating the immunotherapy-responder and non-responders.
3.To characterize the immune-cell infiltration dysregulation in the responder and non-responders in response to chemo+immunotherapy
4.To assess quality of life in patients receiving immunotherapy.
5.To assess adverse events as per Common Terminology Criteria for Adverse event 		 1.at baseline
2.At 8 weeks, at end of treatment, and during follow-up (up to 12 months).
3.At baseline, 8 weeks, and at follow-up (12 months).
4.At baseline, 2–4 months, and at follow-up (12 months).
5. At each clinical visit during treatment and follow-up. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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   N/A 
Date of First Enrollment (India)   21/10/2025 
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="3"
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   Oral squamous cell carcinoma (OSCC) is a prevalent and aggressive form of cancer in India, posing a significant public health challenge. While conventional treatments like chemotherapy and radiotherapy are utilized, their efficacy is often limited, resulting in poor survival rates. Immunotherapy, a promising alternative, leverages the body’s own immune system to combat cancer by reversing T-cell inactivation and immunosuppression through the blockade of immune check point molecules. This approach has shown encouraging results in various cancers, offering a potential lifeline for OSCC patients. However, a significant hurdle remains: approximately half of all patients do not respond to immunotherapy. This variability in response is attributed to complex genomic factors, including tumor mutation burden, germline Human Leukocyte Antigen profiles, neoantigen burden, and T-cell receptor repertoire diversity. Unfortunately, the specific landscape of these molecular alterations in Indian OSCC patients, particularly in the context of immunotherapy response, remains largely uncharacterized. This lack of knowledge hinders clinicians’ ability to effectively stratify patients and tailor treatment strategies.
To address this gap, a study is proposed to investigate the genomic and transcriptomic profiles of Indian OSCC patients undergoing immunotherapy in conjunction with chemotherapy. The primary objective is to identify molecular markers that differentiate responders from non-responders. By employing high-throughput exome sequencing, whole transcriptome sequencing, and T-cell receptor repertoire sequencing on samples from 100 patients recruited from Tata Memorial Hospital, Mumbai, researchers aim to comprehensively characterize the genomic alterations associated with immunotherapy response. This analysis will include the identification of somatic mutations, mutational signatures, copy-number alterations, copy number signatures, germline HLA alteration profiles, tumor neo antigenic diversity, and T-cell receptor repertoire diversity. Furthermore, the study will characterize the immune-cell in filtration dysregulation in responders and non-responders. The ultimate goal is to develop an integrative scoring system that combines multi-omics immunogenic data to accurately predict patient response to immunotherapy. This research has the potential to significantly improve patient outcomes by enabling personalized treatment strategies, avoiding ineffective therapies, and reducing the financial burden associated with immunotherapy. The study will provide critical insights into the molecular mechanisms underlying immunotherapy response in Indian OSCC patients, paving the way for more effective and targeted cancer care.
 
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