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CTRI Number  CTRI/2024/12/077942 [Registered on: 11/12/2024] Trial Registered Prospectively
Last Modified On: 17/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Other 
Public Title of Study   A Non-comparative clinical study of Toripalimab in Indian patients with recurrent or metastatic Nasopharyngeal carcinoma as monotherapy or along with standard chemotherapy (cisplatin and gemcitabine) 
Scientific Title of Study   A phase 4, multicenter, noncomparative, open-label, two cohort study evaluating the safety and efficacy of intravenously administered toripalimab in the treatment of Indian patients with recurrent or metastatic nasopharyngeal carcinoma 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
TP-02-001 Version 2.0 dated 03 Oct 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Narendra Maharaj 
Designation  Head - Clinical Development 
Affiliation  Dr. Reddys Laboratories Ltd. 
Address  Biologics, Survey Nos. 47 and 44 Part, Bachupally Village, Bachupally Mandal, Medchal Malkajgiri District

Hyderabad
TELANGANA
500090
India 
Phone  4044644000  
Fax    
Email  narendramaharaj@drreddys.com  
 
Details of Contact Person
Public Query  
Name  K Ranjith 
Designation  Head - Project Delivery 
Affiliation  Dr. Reddys Laboratories Ltd. 
Address  Biologics, Survey Nos. 47 and 44 Part, Bachupally Village, Bachupally Mandal, Medchal Malkajgiri District

Hyderabad
TELANGANA
500090
India 
Phone  4044644000  
Fax    
Email  ranjithk@drreddys.com  
 
Source of Monetary or Material Support  
Dr. Reddy’s Laboratories Ltd. Biologics Survey No.47 and 44(PART), Bachupally Village, Bachupally Mandal, Medchal-Malkajgiri District, Telangana, India, 500090. 
 
Primary Sponsor  
Name  Dr. Reddys Laboratories Ltd. 
Address  Biologics Survey No.47 and 44 PART, Bachupally Village, Bachupally Mandal, Medchal-Malkajgiri District, Telangana, India, 500090. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Dr Reddys Laboratories Ltd   Biologics Survey No.47 and 44(PART), Bachupally Village, Bachupally Mandal, Medchal-Malkajgiri District, Telangana, India, 500090 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saroj Kumar Das Majumdar  AIIMS, Dept. of Radiation Oncology  AIIMS, Sijua, Patrapada, Khorda, Bhubaneswar, Orissa, India, 751019
Khordha
ORISSA 		 9438884066

sarojmajumdar@gmail.com 
Dr Prabrajya Narayan Mohapatra  Apollo Multi speciality Hospitals Limited  58, Canal Circular Road, Kolkata - 700 054, West Bengal, India
Kolkata
WEST BENGAL 		 9774311610

prabrajya.mohapatra@rediffmail.com 
Dr Durga Prasad Nanda  Chittaranjan National Cancer Institute  R-6 Building Room no 101, Clinical Research Department, OPD-7, Ground, Floor,37,S.P.MukherjeeRoad, Kolkata-700026, WEST BENGAL
Kolkata
WEST BENGAL 		 9433010993

durgaprasad.nanda@gmail.com 
Dr Ashish Singh  Christian Medical College Vellore  Basement floor A0001, Department of Medical Oncology, Christian, Medical College Vellore, Ranipet Campus, Kilminnal, Village,Ranipet, Vellore, Tamil Nadu - 63251
Vellore
TAMIL NADU 		 6383442826

todrashish@gmail.com 
Dr Rajjyoti Das  Dr. B. Borooah Cancer Institute  Room No. 29, OPD Building, AK Azad Road, Gopinath Nagar Rd, Bishnu, Rabha Nagar,Guwahati, Assam 781016
Kamrup
ASSAM 		 9435087642

DR_rajjyoti@yahoo.co.in 
Dr Sajjan Rajpurohit   Dr. B.L. Kapur Memorial Hospital  Pusa Road, New Delhi-110005
New Delhi
DELHI 		 9999660200

sajjanrajpurohit@gmail.com 
Dr Minish Jain  Grant Medical Foundation, Ruby Hall Clinic  40, Sassoon Road, Pune 411001 Maharashtra, India
Pune
MAHARASHTRA 		 9823133390

minishjain009@gmail.com 
Dr Vashista Maniar  MOC Cancer Care & Research Centre  Consulting 2, Clinical Research 1 to 4, Floor-1st, Shreepati Arcade, August Kranti Marg,Nana, Chowk, Mumbai, Maharashtra-400036
Mumbai
MAHARASHTRA 		 9819834571

vpm@mocindia.co.in 
Dr NarayananKutty Warrier  MVR Cancer Centre and Research institute  Room No. 04, Department of Medical Oncology, Cp13/516 B.C, Vellalasseri (vai) NIT, Poolacode, Kozhikode 673601
Kozhikode
KERALA 		 9495617585

drnkwarrier@mvrccri.co 
Chandrakanth M V  Rabindranath Tagore International Institute of Cardiac Sciences   Premises No 1489, (124), Mukundapur, E. M. Bypass, Kolkata - 700099
Kolkata
WEST BENGAL 		 7003206633

drmvch@gmail.com 
Dr Syed Nisar Ahmed  Sher -i-Kashmir Institute of Medical Sciences  304, 3rd floor, Department of Medical Oncology, Main Rd, Soura, Srinagar, Jammu and Kashmir 190011, India
Srinagar
JAMMU & KASHMIR 		 9469664186

syednisar76@yahoo.co.in 
Dr Satheesh C T  Spandana Oncology Centre,  #919, New No. 68, 28th Main Road, 9th Block, Jayanagar, Bengaluru, Karnataka -560069
Bangalore
KARNATAKA 		 9242698750

drsatheeshct@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Dr. B.L. Kapur Memorial Hospital Ethics Committee  Approved 
IEC for Spandana Oncology Centre  Approved 
IEC office, MVR Cancer Centre and Research Institute  Approved 
IEC-SKIMS Sher-i-kashmir Institute Of Medical Sciences  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee, AIIMS, Bhubaneswar  Approved 
Institutional Ethics Committee, CNCI 1st Campus  Approved 
Institutional Review Board (IRB)Ethics Committee (Silver) Office of Research  Approved 
Medical Ethics Committee, Dr.Borooah Cancer Institute  Approved 
Mumbai Oncocare Centre Institutional Ethics Committee  Approved 
NHRTIICS Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C119||Malignant neoplasm of nasopharynx,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Toripalimab  240 mg fixed-dose IV infusion on Day 1 of each 21-day cycle for cohort-1 3 mg/kg IV infusion on Day 1 of each 14-day cycle for cohort-2 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Age ≥18 years and ≤75 years.
2. Histological/cytological confirmation of NPC.
3. Patients with cohort 1: De novo metastatic stage IVB NPC without previous systemic chemotherapy
OR Recurrent NPC without previous systemic chemotherapy not amenable for locoregional treatment or curative treatment
OR Recurrent NPC after curative treatment (including radiotherapy and/or induction, concurrent or adjuvant chemotherapy), with an interval between recurrence and the last dose of previous radiotherapy or chemotherapy of more than 6 months.
Cohort 2 Unresectable or metastatic NPC who had received prior platinum-based chemotherapy for treatment of recurrent or metastatic NPC or had disease progression within 6 months of completion of platinum-based chemotherapy administered as neoadjuvant, adjuvant, or definitive chemoradiation treatment for locally advanced disease.
4. Patients with at least 1 measurable lesion according to RECIST v1.1 criteria.
5. Life expectancy ≥3 months.
6. ECOG performance status ≤2
7. Patients demonstrating adequate organ function as defined by following values for clinical laboratory all parameters performed within 96 hours of treatment initiation (unless dysfunction is felt to be secondary as determined by the treating investigator)
a. Hematology: Leukocytes more than 3.0 109 per L, absolute neutrophil count (ANC) less than 1.5 109 per L, hemoglobin ≥9 g/dL, and platelet count more than 100 × 109 per litre.
b. Liver function tests: Bilirubin ≤1.5× upper limit of normal (ULN) or direct bilirubin less than ULN for patients with total bilirubin levels more than 1.5 ULN (patients with known Gilberts disease who have serum bilirubin level less than 3 ULN may be enrolled); aspartate aminotransferase and alanine aminotransferase; alkaline phosphatase less than 3 ULN [ALP less than 5 ULN if liver or bone metastases]; international normalized ratio or activated partial thromboplastin time less than 1.5 ULN.vq.
c. Renal function tests: Serum creatinine less than 1.5 ULN and creatinine clearance more than 60 mL per min according to Cockcroft-Gault formula
8. Patients who have experienced toxicities from any prior therapy, surgery, or radiotherapy only if severity is resolved to grade 0 or 1 as per the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE).
9. Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
10. Women patients if they are of:
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including women who have had a hysterectomy, bilateral oophorectomy (ovariectomy), or bilateral tubal ligation or are postmenopausal (total cessation of menses for ≥1 year).
Childbearing potential and have a negative serum pregnancy test at screening (within 7 days of the first administration of study intervention), have used adequate contraception before study entry, with use adequate contraception throughout the study until 4 months after the last administration of study intervention.
8. Patients who have experienced toxicities from any prior therapy, surgery, or radiotherapy only if severity is resolved to grade 0 or 1 as per the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE).
9. Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
10. Women patients if they are of:
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including women who have had a hysterectomy, bilateral oophorectomy (ovariectomy), or bilateral tubal ligation or are postmenopausal (total cessation of menses for ≥1 year).
Childbearing potential and have a negative serum pregnancy test at screening (within 7 days of the first administration of study intervention), have used adequate contraception before study entry, with use adequate contraception throughout the study until 4 months after the last administration of study intervention. 
 
ExclusionCriteria 
Details  1.Patients with history of severe hypersensitivity reactions to toripalimab, other monoclonal antibodies (mAbs), or any excipient of toripalimab injection such as citrate, sodium citrate, sodium chloride, mannitol, or polysorbate 80.
2. Patients with active or untreated central nervous system metastases as determined on computed tomography or magnetic resonance imaging during screening and/or prior radiographic assessments. Patients who have received prior therapies for brain or leptomeningeal metastasis should be clinically stabilized for more than 2 months and should have discontinued systemic steroids therapy more than 4 weeks before Day 1 of Cycle 1 to be eligible for inclusion. This exception does not include patients with carcinomatous meningitis as they will be excluded regardless of clinical stability.
3.Patients with spinal cord compression not definitively treated with surgery and/or radiation or patients with previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for more than 2 weeks prior to Day 1 of Cycle 1.
4. Patients with necrotic lesions that have potential risk of massive hemorrhage at the discretion of investigator.
5. Patients with uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. Patients with indwelling catheters (e.g., PleurX catheter) may be enrolled as per investigator discretion after discussion with sponsor medical monitor.
6. Patients with malignancies other than NPC within 5 years prior to Day 1 of Cycle 1. Such patients may be enrolled only if they have a negligible risk of metastasis or death and have experienced expected curative outcome after treatment (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, or ductal carcinoma in situ treated surgically with curative intent).
7. Patients who have received prior therapy targeting PD-1 receptor, its ligand PD-L1, or cytotoxic T-lymphocyte-associated protein 4 (CTLA4) receptor.
8. Patients on antineoplastic traditional herbal medicine within 4 weeks before first dosing cycle.
9. Patients who have not recovered from the effects of major surgery or significant traumatic injury other than diagnosis of NPC at least 14 days before the first dose of study treatment.
10. Patients with history of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
11. Patients who have received systemic immunostimulatory agents (including, but not limited to, interferons or interleukin 2) within 4 weeks or 5 half-lives of toripalimab, whichever is shorter, prior to first dosing cycle.
12. Patients who have received systemic corticosteroids or other systemic immunosuppressive medications (including, but not limited to, prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to first dosing cycle. Patients contraindicated for IV contrast requiring steroid pretreatment should have baseline and subsequent tumor assessments performed on MRI.
13. Patients who have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs)  Baseline up to end of study (EoS) for both the cohorts
cohort-1-screening, week-1,4,7,10,13,16,19,22 and 25
cohort-2-screening,week- 1,3,5,7,9,11,13,15,17,19,21,23 and 25 
 
Secondary Outcome  
Outcome  TimePoints 
Safety End points:-
-Incidence of AESIs including immune-related adverse events (AEs), anaphylactic reactions, hypersensitivity reactions and other infusion-related reactions.
-Proportion of patients with abnormal and clinically significant results for vital signs, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory parameters 		 Safety End points:
Baseline up to EoS.
Efficacy End points:
PFS rate at 24 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 4 
Date of First Enrollment (India)   20/12/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  
Toripalimab(PD-1 inhibitor) is approved in the United States for NPC.In China, it is approved (under the brand name TUOYI®) for multiple oncology indications including NPC.
The proposed study is "A phase 4, multicenter, noncomparative, open-label, two cohort study evaluating the safety and efficacy of intravenously administered toripalimab in the treatment of Indian patients with recurrent or metastatic nasopharyngeal carcinoma".The trial will include a screening period(up to 4 weeks),a treatment phase(8 weeks for cohort-1 and 12 weeks for cohort -2). the total duration of individual participation will be approximately 25 weeks.
Patients who qualify the selection criteria will be selected for either of the cohort-1 or cohort-2 and Toripalimab will be administered intravenously either with the standard chemotherapy drugs cispaltin and gemcitabine for every 3 weeks or as monotherapy for every 2 weeks.Safety and efficacy assessments will be done as per the planned time points.
 
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