CTRI/2026/02/103216 [Registered on: 06/02/2026] Trial Registered Prospectively
Last Modified On:
03/02/2026
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Retrospective Chart Review
Study Design
Other
Public Title of Study
Real-World Outcomes of Immunotherapy (Anti PD-1) in Indian Patients with Recurrent/Metastatic Head and neck cancers
Scientific Title of Study
A multicenter observational study to explore the outcomes of use of nivolumab (or anti-pd1) monotherapy in Indian patients with recurrent or metastatic SCCHN in a real- world setting: a retrospective chart review
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CA209-1525
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Disha S R
Designation
Disease Area Specialist
Affiliation
Bristol Myers Squibb
Address
Bristol-Myers Squibb India Pvt. Ltd.
One International Center, 6th Floor, Tower 1,
Senapati Bapat Marg, Elphinstone (W), Mumbai-
Mumbai MAHARASHTRA 400013 India
Phone
02266288600
Fax
Email
disha.sr@bms.com
Details of Contact Person Scientific Query
Name
Disha S R
Designation
Disease Area Specialist
Affiliation
Bristol Myers Squibb
Address
Bristol-Myers Squibb India Pvt. Ltd.
One International Center, 6th Floor, Tower 1,
Senapati Bapat Marg, Elphinstone (W), Mumbai-
MAHARASHTRA 400013 India
Phone
02266288600
Fax
Email
disha.sr@bms.com
Details of Contact Person Public Query
Name
Disha S R
Designation
Disease Area Specialist
Affiliation
Bristol Myers Squibb
Address
Bristol-Myers Squibb India Pvt. Ltd.
One International Center, 6th Floor, Tower 1,
Senapati Bapat Marg, Elphinstone (W), Mumbai-
MAHARASHTRA 400013 India
Phone
02266288600
Fax
Email
disha.sr@bms.com
Source of Monetary or Material Support
Bristol Myers Squibb India Private Limited One International Centre, 6th Floor, Tower 1, Senapati
Bapat Marg, Elphinstone (W), Mumbai - 400013, India
Primary Sponsor
Name
Bristol Myers Squibb India Private Limited
Address
One International Centre 6th Floor Tower 1 Senapati Bapat Marg
Elphinstone (W) Mumbai 400013 India
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 8
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Rakesh Neve
Lifepoint Multispeciality Hospital
OPD Room No 001, Department-Medical Oncology, Division Oncology, 3rd Floor, Reserach Department, Sr. No. 145/1, Mumbai banglore Highway, Near Hotel Sayaji, Wakad, Pune-411057, Maharashtra, India
Pune MAHARASHTRA
9881143140
rakeshneve05@gmail.com
Dr Chandrakanth MV
Narayana Superspeciality Hospital
OPD Room No 1, Department Medical Oncology, Division Oncology, 120/1, Andul Road, Near Nabanna, Junction Between Andul Road and Second Hooghly Bridge, Shibpur, Howrah, Kolkata, West Bengal-711103
Kolkata WEST BENGAL
7738519198
drmvch@gmail.com
Dr M N Baruah
North East Cancer Hospital and Research Institute, Guwahati
OPD Room No-2, Department Medical Hemato Oncology, Division-Oncology,
A 2 Sarvodaya Nagar, Shivaji Nagar Kanpur, Uttar Pradesh 208005
India
Kanpur Nagar UTTAR PRADESH
9769890961
vikasttalreja@gmail.com
DrKumar Prabhash
Tata Memorial Center
Tata Memorial Centre, Department of Medical Oncology, HBB Block, 2nd Floor, Room no 204 Dr. Ernest Borges Marg, Parel, Mumbai – 400012, Maharashtra, India Mumbai MAHARASHTRA
"Institutional Ethics Committee P.D. Hinduja Hospital & Medical Research Centre
Submittted/Under Review
Institutional Ethics committee, NECHRI
Submittted/Under Review
NSH Ethics Committee
Approved
Regency Hospital Ethics Committee
Approved
Vedant Hospital Institutional Ethics Committee
Approved
Yashoda Academy of Medical Education and Research
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C439||Malignant melanoma of skin, unspecified,
Intervention / Comparator Agent
Type
Name
Details
Intervention
NIL
NIL
Comparator Agent
NIL
NIL
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
Patients EMR must meet all the following inclusion criteria to participate in the study
1 Adults (male or female) 18 years or older at index date.
2 Confirmed documented diagnosis of R M SCCHN (as per treating physician discretion),
from any of the following primary anatomic sites (including but not limited to) oral cavity,
oropharynx, hypopharynx, nasopharynx, larynx, salivary glands, ocular, and
parapharyngeal sites.
3 Patients who have received a minimum of 4 cycles of nivolumab monotherapy for R M
SCCHN at approved dose of 3 mg per kg every 2 weeks (30 minute intravenous infusion), as
per prescribing information (Appendix 1) except in case of disease progression, death, any
other reason
The 3 mg per kg, 14 day (2 week) period constitutes a cycle. Thus, the overall treatment period for 4 cycles of
nivolumab spans around 8 weeks.
a Patients who had prior exposure to platinum based chemotherapy for R M SCCHN.
b Patients who have up to 6 months of baseline or pre-index period data available in EMR.
c Patients who have at least 12 months of follow up data available in EMR from the index
date until end of study observation period (31 December 2024) or early discontinuation
(patient switching to subsequent therapy, death, lost to follow-up, disease progression or
any other reason, whichever occurred first) except in case of death within 12 months from
index date.
ExclusionCriteria
Details
Patients EMR meeting any of the following criteria will be excluded from the study
1 Patients who received nivolumab 4monotherapy at a dose other than the approved dose of 3 mg per kg every 2 weeks (as per prescribing information, Appendix 1).
2 Patients who received other immunotherapy (immune checkpoint inhibitors such as
PD-1 or PD-L1 inhibitors, anti-CTLA-4 agent) before switching to nivolumab monotherapy.
3 Patients who received a combination of nivolumab with any other agent (eg, chemotherapy,
targeted therapy, etc.).
Patients who enrolled in a clinical trial for cancer treatment since the diagnosis of R M
SCCHN.
4 Patients with a diagnosis of cancer other than R M SCCHN within the past 5 years, that
required systemic or other relevant treatment.
5 Pregnant or breastfeeding women initiating nivolumab monotherapy for R M SCCHN.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Blinding/Masking
Primary Outcome
Outcome
TimePoints
To assess the real-world overall survival (rwOS) among patients with recurrent or metastatic Squamous cell
carcinoma of head and neck (R/M SCCHN) treated with nivolumab monotherapy up to 4 years post-index
follow-up time period.
The clinical outcomes will be assessed at specific time points during the post-index (follow-up) period for (eg, at Month 0, 6, 9, 12, 18, 24, 30, 36, etc. [as available]).
Secondary Outcome
Outcome
TimePoints
To determine rwPFS & real-world overall response rate rwORR, including complete response CR partial response PR stable disease SD & disease progression DP as per iRECIST immune Response Evaluation Criteria In Solid Tumors criteria among patients with recurrent metastatic SCCHN on nivolumab monotherapy during the post index follow up time period
The clinical outcomes will be assessed at specific time points during the post-index (follow-up) period for (eg, at Month 0, 6, 9, 12, 18, 24, 30, 36, etc. [as available]).
Target Sample Size
Total Sample Size="300" Sample Size from India="300" 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)
27/02/2026
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="1" 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
In India, Head and neck cancers account for about 30% of all cancers in men and around 16% in women. Considered as an emerging public health concern, HNC in Indian population has a distinct demographic profile, risks factors, pathophysiology, and patient characteristics.
The landmark CheckMate 141 study demonstrated prolonged benefits and favorable safety profile with nivolumab monotherapy in Asian population (Japan, Taiwan, Korea, and Hong Kong) with R/M SCCHN.Thus, the regimen was approved across Asia, including India for the treatment of R/M SCCHN after platinum-based therapy, although with limited country-specific data.
As such, the current study aims to gain insights through real-world evidence on the clinical outcomes and safety profile of nivolumab monotherapy (when prescribed at approved dose among Indian patients with R/M SCCHN. This study aims to characterize the clinical outcomes, safety profile, treatment modalities, and demographic/clinical profile among Indian patients with R/M SCCHN on nivolumab monotherapy.
This is a retrospective chart review where electronic medical records will be screened for patients that fit into the eligibility criteria.