CTRI/2026/02/103512 [Registered on: 10/02/2026] Trial Registered Prospectively
Last Modified On:
22/09/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
This is a comparative study of Nivolumab in participants with melanoma(skin cancer) requiring additional treatment with nivolumab.
Scientific Title of Study
A randomized, double-blind, parallel-group study to compare pharmacokinetics of JPB898(proposed nivolumab biosimilar) and US-licensed Opdivo in participants with resected stage IIB, IIC, or III melanoma requiring adjuvant treatment with nivolumab.
Trial Acronym
NivoStream
Secondary IDs if Any
Secondary ID
Identifier
2025-521919-39-00
EudraCT
CJPB898A12101 V 2.1 dated 28 Nov 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Rakesh Patel
Designation
Head - Clinical Operations
Affiliation
Veeda Clinical research Limited
Address
Veeda Clinical Research Ltd., Shivalik Plaza, Near I.I.M.,Ambawadi, Ahmadabad Ahmadabad GUJARAT
Ahmadabad GUJARAT 380015 India
Phone
8308843660
Fax
Email
Rakesh.Patel@veedalifesciences.com
Details of Contact Person Scientific Query
Name
Dr Ravi Alamchandani
Designation
General Manager
Affiliation
Veeda Clinical research Limited
Address
Veeda Clinical Research Ltd., Shivalik Plaza, Near I.I.M.,Ambawadi, Ahmadabad Ahmadabad GUJARAT
Ahmadabad GUJARAT 380015 India
Phone
9687306158
Fax
Email
Ravi.A1950@veedalifesciences.com
Details of Contact Person Public Query
Name
Dr Ravi Alamchandani
Designation
General Manager
Affiliation
Veeda Clinical research Limited
Address
Veeda Clinical Research Ltd., Shivalik Plaza, Near I.I.M.,Ambawadi, Ahmadabad Ahmadabad GUJARAT
GUJARAT 380015 India
Phone
9687306158
Fax
Email
Ravi.A1950@veedalifesciences.com
Source of Monetary or Material Support
Hexal AG
Industriestr. 25, 83607 Holzkirchen, Germany
Primary Sponsor
Name
Hexal AG
Address
Industriestr. 25, 83607 Holzkirchen, Germany
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Veeda Clinical Research Ltd
Shivalik Plaza, Near I.I.M., Ambawadi Ahmedabad 380 015, Gujarat, India
Countries of Recruitment
Georgia India Italy Republic of Moldova Romania Spain
Room No.: 4002, Ground Floor, OPD Building, Block-D
Department of Radiation Oncology, All India Institute of
Medical Science, Bathinda, Mandi Dabwali Road, Jodhpur
Romana, Bathinda, Punjab-151001 India Bathinda PUNJAB
9478280097
sapnamarcus@gmail.com
Dr Sourav Kumar Mishra
AIIMS, Bhubaneshwar
Dept of Medical Oncology, Ground Floor, G-Block, Sijua, Patrapada-751019 Khordha ORISSA
7008651823
drskmishra1984@gmail.com
Dr Sameer Rastogi
AIIMS, New Delhi
Room 216, Department of medical Oncology, , 2nd floor, Dr.BRA:IRCH, Ansari Nagar, New Delhi-110029 New Delhi DELHI
9958975343
samdoc_mamc@yahoo.com
Dr Rakesh Reddy Boya
Apollo Hospital
1st floor, oncology block, Health city, Arilova, Chinnagadilli,AP-530040 Visakhapatnam ANDHRA PRADESH
OPD No.47, Medical Oncology, 1st floor, Father Muller Medical College and Hospital, Father Muller Road, Mangolore, Karnataka
Dakshina Kannada KARNATAKA
9167273040
drnishithashetty@gmail.com
DrKaushalkumar BPatel
First Cure Hospital
First Cure Hospital, 2nd and 3rd Floor VIP Galleria, Above Alpha Bazaar-Bhimrad Canal Road, Althan, Surat – Gujarat,395017
Surat GUJARAT
9723431102
kpatel291980@yahoo.com
Dr Indumati Ambulkar
HCG Cancer Centre Borivali
"HCG cancer centre, 3rd floor OPD, IC colony
off Borivali-Dahisar new link road, Borivali West Mumbai- 400092"
Mumbai MAHARASHTRA
9870041463
drindoo.a@hcgel.com
Dr Pendse Shantanu Shirishkumar
HCG Cancer Centre, Nagpur
"HCG Canter Centre Nagpur, Room No. 2,
Ground Floor, khasra No. 50,51, mouja wanjri bande nawaz Nagar, Near Acuomotive 59. Kalamna Ring Road, Nagpur"
Nagpur MAHARASHTRA
8600863057
drshantanu.s@hcgel.com
Dr Raj Nagarkar
HCG Manavta Cancer Centre
Department of Clinical Research, Behind Shining Auto, Mumbai Naka, Nashik-422002 Nashik MAHARASHTRA
Kh.no. 50/51, Mouja Wanjari, Bande Nawaz Nagar Near Automotive Square, Kalamna, Ring Road Nagpur Nagpur Maharashtra - 440026 Nagpur MAHARASHTRA
8600869059
drshantanu.s@hcgel.com
Dr Smita Kayal
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
3rd floor, department of Medical Oncology, Super speciality block, (SSB), JIPMER, Dhanvantari Nagar. Gorimedu. puducherry 605006
Pondicherry PONDICHERRY
Room No. 21, 10th Floor, Medanata Cancer Institute, Medanta -The Medicity
Gurgaon HARYANA
9810212235
ashok.vaid@medanta.org
Dr Ashish Joshi
MOC Cancer Care and Research Centre
1st Floor SS house Nehru Road, Navpada, Villeparle East, Mumbai 400057 Mumbai MAHARASHTRA
8879026609
ashjoshi@mocindia.co.in
Dr Vaibhav Choudhary
Nanavati Max Super Speciality Hospital
Clinical Research Department, Basement-III, Near Auditorium, ACRO OPD, S.V. Road, Vile Parle (W), Mumbai-400056 Mumbai MAHARASHTRA
9833621049
dr.vaibhav155@gmail.com
Dr Avik Maji
Nil Ratan Sircar Medical college and Hospital
Nil Ratan Sircar Medical College and Hospital, 138, Acharya Jagadish Chandra Bose Road, Kolkata 700014, West Bengal, India
Kolkata WEST BENGAL
9233268066
draviknational@gmail.com
Dr Ghanshyam Nanubhai Patel
Nirmal Hospital
Department of Oncology, Ring Road, Surat, Gujarat-395002 Surat GUJARAT
9376913131
drgnpatelonco@gmail.com
Dr Srinivasa G Y
PGIMER
Department of Radiotherapy and Oncology, Ground Floor, Regional Cancer Centre, Nehru Extension Block, PGIMER, Sector 12, Chandigarh-160012 Chandigarh CHANDIGARH
9805803262
drsrinivasagowda@gmail.com
Dr Surender Kumar Beniwal
S. P. Medical College and AG Hospital
Department of Medical Oncology, Sardar Patel Colony, Bikaner-334003 Bikaner RAJASTHAN
9782300231
beniwal.surendra@gmail.com
Dr Tushar Patil
Sahyadri Super speciality Hospital Deccan
Plot no. 30C, Erandarone, Karve Rood First floor, Pune-411004 Pune MAHARASHTRA
9552522556
tussipats@hotmail.com
Dr Anita Ramesh
Saveetha Medical College and Hospital
Room 115, corporate building, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu- 601105 Chennai TAMIL NADU
9840758567 4466726623 anitachandra100@hotmail.com
Dr Kikani Alpeshkumar Jayantilal
Shashwat cancer care LLP
Shashwat cancer care LLP 2nd floor, CIGIS Hospital, Near Balaji Hall, 150 feet Ring Road, Rajkot, 36004
Rajkot GUJARAT
9601649096
alpesh.kikani@shashwat.one
Dr Mukesh Kumar
SMS Medical College
Department of Medical Oncology, Ground Floor, State Cancer Institute, JLN marg, 302004 Jaipur RAJASTHAN
9001468743
mukeshrulania008@gmail.com
Dr Naresh Somani
Somani Hospital
Department of medical oncology, 277-278, Shri Gopal Nagar, 80- feet road, Gopalpura Bypass, Jaipur- 302019 Jaipur RAJASTHAN
6376341881
somanihospitaltrials@gmail.com
Dr Satheesh C T
Spandana Oncology Centre
Department of Clinical Research, #919, New No. 68, 28th main road, 9th block, Jayanagar, Bengaluru, Karnataka-560069 Bangalore KARNATAKA
"OPD No.1, Ground floor, Vedant Multispeciality Hospital, GP 83, Opp to Rotary Club, Sambhajinagar,
MIDC,Chinchwad, pune-411019"
Pune MAHARASHTRA
9823602626
rnwategaonkar@gmail.com
Dr Arjun Mandade
Vivekanand Medical Foundation and Research Centre
"Department of Medical Oncology, Room No-4,Vivekanand Medical Foundation and Research Centre, Plot no.
55, Opp. Fort Showroom, MIDC, Latur, MH 413531"
Latur MAHARASHTRA
(1) ICD-10 Condition: C439||Malignant melanoma of skin, unspecified,
Intervention / Comparator Agent
Type
Name
Details
Intervention
JPB898 proposed Nivolumab biosimilar
Dose Formulation: Solution for infusion, Dose Strength : 480 mg Q4W,
Route of Administration: i.v. infusion, Duration of Dose: Each participant will receive study intervention as per randomization schedule every 4 weeks for 49 weeks.
Comparator Agent
Opdivo-US - Nivolumab
Dose Formulation: Solution for infusion, Dose Strength : 480 mg Q4W, Route of Administration: i.v. infusion, Duration of Dose: Each participant will receive study intervention as per randomization schedule every 4 weeks for 49 weeks.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
1. Signed informed consent obtained before participation in the study.
2. Male or female participants greater than or equal to 18 years of age or of age of legal majority, whichever is higher, on day of signing informed consent.
3. Participants must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
4. Histologically confirmed melanoma.
5. Completely surgically resected (including sentinel lymph node if applicable), stage IIB, IIC, or III cutaneous melanoma, classified per AJCC 8th edition with pathology reports confirming negative margins on the resected specimens (per local standard).
6. Disease-free status (no loco-regional relapse or distant metastasis, no clinical evidence for brain metastases) as supported by a complete physical examination and post-surgical tumor imaging (within 28 days prior to first study treatment).
7. Minimum 2 to maximum 12 weeks from final surgical resection or sentinel lymph node biopsy to first study treatment with adequate wound healing (as per the Investigator’s judgement) from the surgery
8. If radiotherapy was indicated after lymph node dissection, completed before first study treatment
9. Adverse effects resulting from prior radiotherapy or other antineoplastic therapy must have resolved to CTCAE grade 1 (or lower).
10. Participant has recovered adequately from toxicity and/or complications from surgery prior to study start
11. ECOG performance status of 0 or 1
ExclusionCriteria
Details
1. Known history or evidence of uveal or ocular melanoma at time of screening.
2. Prior active non-melanoma malignancy within the previous 1 year that has not been treated or that still requires any concomitant systemic therapy (except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).
3. Active autoimmune disease that has required chronic systemic treatment in the past 12 weeks.
-Participants with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted.
4. Participants with a condition requiring systemic treatment with either corticosteroids (greater than equal to 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
5. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD37, anti-CTLA-4, anti-LAG-3, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
6. Abnormal safety laboratory results at screening or baseline.
WBC less than 2000 per microlitre
Neutrophils less than 1500 per microlitre
Platelets less than 100 × 103 per microlitre
Haemoglobin less than 9.0 gram per decilitre
Serum creatinine greater than 1.5 times ULN
However, if creatinine clearance greater than or equal to 40 mL per min - calculated using the Cockcroft Gault formula below, then the participant is eligible:
Female CrCl = (140 - age in years) x weight in kg 0.85 / 72 x serum creatinine in mg/dL
Male CrCl = (140 - age in years) weight in kg x 1.00 / 72 x serum creatinine in mg/dL
AST greater than 3.0 times ULN
ALT greater than 3.0 times ULN
Total bilirubin greater than 1.5 times ULN (participants with Gilbert Syndrome: greater than or equal to 3.0 times ULN).
7. Participants with history of or active pneumonitis/interstitial lung disease, and history of allogeneic transplant(organ or bone marrow).
8. Inadequate recovery from any major surgery (with ongoing toxicity or other
complications) at time of screening.
9. Known history of hypersensitivity to the active components and excipients of the study treatment.
10. Known history or current diagnosis of clinically significant cardiac abnormalities that may increase the risk associated with study participation.
11. Known history of a medical condition or an underlying advanced, severe and uncontrolled condition which in the opinion of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product, or that might affect participant safety or interpretation of the study results.
12. Known history or current diagnosis of HIV
(i.e. HIV 1/2 antibodies positive).
13. Active Hepatitis B or Hepatitis C(e.g. HBsAg positive or HBcAb positive and subsequently quantitative HBV DNA PCR positive) or Hepatitis C (i.e. HCV Ab positive and subsequently quantitative HCV RNA results greater than the lower limits of detection of the assay).
14. Known alcohol, drug, or substance abuse within 12 months prior to first study treatment.
15. Use of other investigational drugs at the time of screening, or within 5 half-lives of the other investigational drug before first study treatment, or within 3 months, whichever is longer.
16. Pregnant (confirmed by serum pregnancy test) or breastfeeding women
17. Legally institutionalized, or those under judicial protection
18. Immediate family member (i.e., spouse, parent/legal guardian, sibling, or a child) being a member of study site staff or being a member of the Sponsor’s study team.
19. Women of child-bearing potential defined as all women physiologically capable of becoming pregnant, unwilling to use highly effective methods of contraception while taking study treatment and for 5 months after stopping study treatment.
20. Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 5 months after stopping study treatment.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
To demonstrate PK similarity between JPB898 and Opdivo-US – test formulation and Opdivo-US - reference product in participants with resected stage IIB, IIC, or III melanoma requiring adjuvant treatment with nivolumab
A total of 15 PK samples will be collected including pre-dose blood sample on C1D1, C2D1, C3D1, C4D1, C5D1; and post dose blood samples at 0.75 h, 4 h on day 1 and at 24h on day 2 at 168 h on day 8 and 504 h on day 22 after Cycle 1 and Cycle 4
Secondary Outcome
Outcome
TimePoints
To descriptively compare PK, Safety, Immunogenicity of test and reference products
Timepoint:
Cmax in Cycle 1, Cmax,ss in Cycle 4, and
Ctrough,ss at the end of Cycle 4
Blood samples for Immunogenicity will be collected 60 minutes before the start of infusion on C1D1, C2D1, C3D1,C4D1, C5D1.
Safety will be assessed throughout the study duration by AE/SAE assessment
Target Sample Size
Total Sample Size="150" Sample Size from India="70" 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 1
Date of First Enrollment (India)
02/03/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
02/03/2026
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="2" 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 - NO
Brief Summary
This study aims to demonstrate PK similarity between the proposed nivolumab biosimilar JPB898 and the US-licensed reference product Opdivo administered in participants with resected stage IIB, IIC, or III melanoma in the adjuvant setting. The safety and immunogenicity profiles of JPB898 and Opdivo-US will be descriptively compared and evaluated up to the primary analysis at Week 17. After the primary analysis, only safety data will be evaluated in the open-label treatment period until the end of the study duration.
The maximum study duration for a participant will be approximately 57 weeks, including 4 weeks screening, 16 weeks in Treatment Period1, and 36 weeks (±7 days visit window for Week 53/EoS) in Treatment Period2.