| CTRI Number |
CTRI/2026/01/100986 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
11/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Study of Amivantamab in Addition to Carboplatin and Pembrolizumab Compared With Standard of Care- Platinum, Pembrolizumab and 5-FU Alone in Participants With Recurrent/Metastatic Head and Neck Cancer |
|
Scientific Title of Study
|
A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants with Treatment-Naive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma |
| Trial Acronym |
OrigAMI-5 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2025-521917-24 |
EudraCT |
| 61186372HNC3001; Version: Original dated 23 July 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanish Davis |
| Designation |
R and D Director GCO India |
| Affiliation |
Johnson and Johnson Private Limited |
| Address |
Janssen Research and Development Johnson and Johnson Private Limited.
Arena Space, Jogeshwari East
Mumbai
MAHARASHTRA
400060
India |
| Phone |
919820958943 |
| Fax |
|
| Email |
sdavis20@its.jnj.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanish Davis |
| Designation |
R and D Director GCO India |
| Affiliation |
Johnson and Johnson Private Limited |
| Address |
Janssen Research and Development Johnson and Johnson Private Limited.
Arena Space, Jogeshwari East
Mumbai
MAHARASHTRA
400060
India |
| Phone |
919820958943 |
| Fax |
|
| Email |
sdavis20@its.jnj.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanish Davis |
| Designation |
R and D Director GCO India |
| Affiliation |
Johnson and Johnson Private Limited |
| Address |
Janssen Research and Development Johnson and Johnson Private Limited.
Arena Space, Jogeshwari East
Mumbai
MAHARASHTRA
400060
India |
| Phone |
919820958943 |
| Fax |
|
| Email |
sdavis20@its.jnj.com |
|
|
Source of Monetary or Material Support
|
| Johnson and Johnson Pvt Ltd. Arena Space Jogeshwari East, Mumbai, 400060, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Johnson and Johnson Private Limited |
| Address |
HIGI House, L. B. S. Marg, Mulund (West) Maharashtra (India) – 400080 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Australia
Austria
Belgium
Brazil
China
Czech Republic
France
Germany
Hungary
India
Italy
Japan
Mexico
Netherlands
Poland
Portugal
Republic of Korea
Romania
Spain
Taiwan
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chethan R |
All India Institute of Medical Sciences |
Room no 229, 2 ND FLOOR DR.B.R.A. nstitute-Rotary Cancer Hospital, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 India
New Delhi
DELHI |
91 9855757667
chethan2190@gmail.com |
| Dr Raja Thirumalairaj |
Apollo Speciality Hospital |
Research Department, Apollo Speciality Hospital, New No 467, Old No 320, Padma Complex, Anna Salai, Nandanam, Chennai-600035, Tamil Nadu, India.
Chennai
TAMIL NADU |
91 9176640195
drtrajaopd_ash@apollohospitals.com |
| Dr Deepak Gupta |
Bhagwan Mahaveer Cancer Hospital and Research Center |
Research Department, Bhagwan Mahaveer Cancer Hospital and Research Center, Jawahar Lal Nehru Marg, Jaipur-302017 (Raj) India
Jaipur
RAJASTHAN |
91 9828683771
drdeepakgupta@yahoo.co.in |
| Dr Kalyan Kusum Mukherjee |
Chittaranjan National Cancer Institute |
Research Building, 3rd Floor, Room No. 303. 37, S.P. Mukherjee Road, Kolkata-700026, West Bengal, India
Kolkata
WEST BENGAL |
91 9830115905
kkmukherjee4u@hotmail.com |
| Dr Raj Vasantrao Nagarkar |
HCG Manavata Cancer Centre |
Department of Clinical Research, 1st Floor, Room No. NA, Manavata Health Campus, Mumbai Naka, Nashik-422002, Maharashtra , India
Nashik
MAHARASHTRA |
91 9823061929
drraj@manavatacancercentre.com |
| Dr Santosh Vandanasetti |
Kailash Cancer Hospital and Research Centre |
OPD NO:08 Block 03 ground floor, Muni Seva Ashram, Goraj, Waghodia, Vadodara-391760
Vadodara
GUJARAT |
91 9427423693
vandanasetti.santhosh@greenashram.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| IEC-KCHRC |
Approved |
| Institute Ethics Committee |
Approved |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee- of Bhagwan Mahaveer Cancer Hospital and Research Centre |
Approved |
| Institutional Ethics Committee-Clinical Studies-Apollo Hospital Chennai |
Approved |
| Manavata Clinical Research Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, (2) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, (3) ICD-10 Condition: C139||Malignant neoplasm of hypopharynx,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
5-fluorouracil |
Participants will receive 5-fluorouracil (5FU) administered at a dose based on body surface area as a continuous infusion (IV) for four days Q3W. |
| Intervention |
Amivantamab |
Participants will receive amivantamab as a subcutaneous (SC) injection at a dose based on body weight (1,600 mg (2,240 mg for greater than equal to 80 kg) on C1D1; and 2,400/3,360 mg on C1D8 and C1D15 and Q3W from Cycle 2 onwards) for up to 24 months. |
| Comparator Agent |
Carboplatin |
Participants will receive Carboplatin for AUC 5 mg/mL• min IV Q3W. |
| Comparator Agent |
Cisplatin |
Participants will receive cisplatin administered at a dose based on body surface area, IV for 100 mg/m2 Q3W |
| Comparator Agent |
Pembrolizumab |
Participants will receive pembrolizumab 200 mg infusion (IV) at Q3W for up to 24 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Be more than or equal to 18 years of age
2. Have histologically or cytologically confirmed recurrent or metastatic HNSCC that is considered incurable by local therapies
a. eligible primary tumor locations are the oral cavity, oropharynx, hypopharynx, or larynx
b. Must not have a primary tumor site of nasopharynx or primary tumor of unknown location c. Must have documented local testing results per local regulations
d. Human papillomavirus status must be known for participants with primary tumor location in oropharynx via p16 test, HPV DNA test, or high-risk HPV in situ hybridization. Any known p16, HPV DNA, or high-risk HPV ISH status of tumor must be negative
3. Be treatment-naive for systemic therapy in the recurrent or metastatic setting
4. Have an ECOG performance status of 0 or 1
5. Have measurable disease according to Response Evaluation Criteria in Solid Tumors, RECIST version 1.1 |
|
| ExclusionCriteria |
| Details |
1. Have an uncontrolled illness
2. Have untreated brain metastases or history of known presence of leptomeningeal disease
3. Have a history of clinically significant cardiovascular disease
4. Inadequate organ or bone marrow function
5. Known allergies, hypersensitivity, contraindications, or intolerance to excipients of Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU and Hyaluronidase |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Overall Survival (OS)
and Objective Response Rate (ORR) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) |
Up to approximately 3 years 7 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Progression-Free Survival (PFS) |
Up to approximately 3 years 7 months |
| Duration of Response (DOR) |
Up to approximately 3 years 7 months |
| ORR as Assessed by Investigator |
Up to approximately 3 years 7 months |
| Number of Participants with Treatment-Emergent Adverse Events |
Up to approximately 3 years 7 months |
| Number of Participants with Laboratory Abnormalities |
Up to approximately 3 years 7 months |
| Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module 43 (EORTC QLQ-HN43) Symptom Scale Score |
Up to approximately 3 years 7 months |
Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by EORTC QLQCore
(C) 30 Symptom Scale Score |
Up to approximately 3 years 7 months |
| Change from Baseline in Functioning HRQoL, as Measured by Functioning Scales of the EORTC QLQ-C30 EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. |
Up to approximately 3 years 7 months |
| Change from Baseline in Overall HRQoL, as Measured by Global Health Scales of the EORTC QLQ-C30 EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. |
Up to approximately 3 years 7 months |
| Differences Between Treatment Groups (Arms A and B) for EORTC Quality of Life (QLG) Item Library-46 (IL-46) Tolerability Scale Scores |
Up to approximately 3 years 7 months |
| Serum Concentration of Amivantamab |
Up to approximately 3 years 7 months |
| Number of Participants with Serum Anti-Amivantamab Antibodies |
Up to approximately 3 years 7 months |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="30"
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)
|
26/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As notedon this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
- What additional supporting information will be shared?
Response (Others) - The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As notedon this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
- Who will be able to view these files?
Response (Others) - The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As notedon this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
- For what types of analyses will this data be available?
Response (Others) - The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As notedon this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
- By what mechanism will data be made available?
Response (Others) - The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As notedon this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
- For how long will this data be available start date provided 30-06-2031 and end date provided 30-06-2046?
Response (Others) - The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As notedon this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As notedon this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
|
|
Brief Summary
|
The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab, 5- fluorouracil (FU), and platinum therapy (carboplatin or cisplatin) in participants with refractory/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R/M setting. |