| CTRI Number |
CTRI/2025/08/093686 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Other |
|
Public Title of Study
|
Safety study of GME751 (Pembrolizumab Biosimilar) for Patients with Melanoma or Non-Small Cell Lung Cancer |
|
Scientific Title of Study
|
An open-label, multi-center, single arm, rollover study of GME751 (proposed pembrolizumab biosimilar) in participants who are eligible for continued pembrolizumab treatment after participation in CGME751A12101 or CGME751A12301 studies. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2024-513160-25 |
Other |
| CGME751A12302, Version 4.0, dated: 28-Apr-2025 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Annappa Kamath |
| Designation |
Executive Director Project Leadership |
| Affiliation |
Parexel International Clinical Research Private Limited |
| Address |
CoWrks, RMZ EcoWorld, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA
Bangalore
KARNATAKA
560103
India |
| Phone |
9902096914 |
| Fax |
8067723001 |
| Email |
Annappa.Kamath@parexel.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annappa Kamath |
| Designation |
Executive Director Project Leadership |
| Affiliation |
Parexel International Clinical Research Private Limited |
| Address |
CoWrks, RMZ EcoWorld, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA
Bangalore
KARNATAKA
560103
India |
| Phone |
9902096914 |
| Fax |
8067723001 |
| Email |
Annappa.Kamath@parexel.com |
|
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Source of Monetary or Material Support
|
| Hexal AG
Industriestr. 25, 83607 Holzkirchen, Germany |
|
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Primary Sponsor
|
| Name |
Hexal AG |
| Address |
Industriestr. 25, 83607 Holzkirchen, Germany |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Parexel International Clinical Research Private Limited |
CoWrks, RMZ EcoWorld, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA |
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Countries of Recruitment
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Bosnia and Herzegovina
Brazil
Georgia
India
Japan
Lithuania
Macedonia
Malaysia
Mexico
Philippines
Romania
Serbia
South Africa
Spain
Taiwan
Thailand
Turkey
United States of America
Viet Nam
Republic of Korea
Republic of Moldova |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shailesh Bondarde |
Apex Wellness Hospital |
Survey No. 799, Plot No. 187, behind
Prakash Petrol Pump, Govind Nagar,
Nasik 422009, Maharashtra, India
Nashik
MAHARASHTRA |
2532470999
Shaileshbondarde@yahoo.com |
| Dr Chandragouda Dodagoudar |
Dr. B. L. Kapur Memorial Hospital |
Pusa Road, New Delhi-110005, India
Central
DELHI |
011 3040 3040
drchandru1976@yahoo.co.in |
| Dr Akhil Kapoor |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre |
Department of Medical Oncology, Sundar
Bagiya, Near Nariya Gate, Banaras Hindu
University Campus, Varanasi, Uttar
Pradesh-221005 India
Varanasi
UTTAR PRADESH |
05422225022
kapoorakhil1987@gmail.com |
| Dr Sadashivudu Gundeti |
Nizams Institute of Medical Sciences |
Department of Medical Oncology
Panjagutta, Hyderabad, Telangana-500082, India
Hyderabad
TELANGANA |
4023489360
drssgundeti@yahoo.com |
| Dr Vijay Patil |
P D Hinduja Hospital and Medical Research Centre |
Marvella 724, 11th Road, Khar West,
Mumbai, Maharashtra-400052, India
Mumbai
MAHARASHTRA |
02261548989
vijaypgi@gmail.com |
| Dr Kumar Prabhash |
Tata Memorial Centre |
11th floor, Homi Bhabha block, Tata
Memorial Hospital, Dr. Ernest Borges
Road, Parel Mumbai-400012,
Maharashtra, India
Mumbai
MAHARASHTRA |
02224177000
kprabhash1@gmail.com |
| Dr Harsha Suryakant Panchal |
The Gujarat Cancer & Research Institute (M.P. Shah Cancer Hospital) |
Civil Hospital Campus, Asarwa, Ahmedabad 380016 Gujarat India
Ahmadabad
GUJARAT |
91 79 2268 8095
harsha.panchal@gcriindia.org |
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Details of Ethics Committee
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| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Apex Wellness Ethics Committee Apex wellness hospital, Survey No. 799, Plot No. 187, behind Prakash Petrol Pump, Govind Nagar, Nasik 422009, Maharashtra, India |
Approved |
| Dr. B. L. Kapur Memorial Hospital Ethics Committee Dr. B.L.Kapur Memorial Hospital, Pusa Road, New Delhi-110005, India |
Not Applicable |
| GCRI/GCP Ethics Committee The Gujarat Cancer & Research Institute M.P. Shah Cancer Hospital, Civil Hospital Campus, Asarwa, Ahmedabad 380016 Gujarat India |
Approved |
| IEC I & II: Institutional Ethics Committee, Clinical Research Secretariat, 3rd Floor, Main Building, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai – 400012, Maharashtra, India |
Submittted/Under Review |
| Institutional Ethics Committee, MPMMCC & HBCH, Varanasi, Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Sundar Bagiya, Near Nariya Gate, Banaras Hindu University Campus, Varanasi, Uttar Pradesh-221005. India |
Not Applicable |
| Institutional Ethics Committee, PD Hinduja Hospital and Medical Research Centre, Veer Savarkar Marg, Mahim, Mumbai, Maharashtra-400016, India |
Submittted/Under Review |
| NIMS-Institutional Ethics Committee 2nd floor, SRC, NIMS old block, Panjagutta, Hyderabad, Telangana-500082, India |
Not Applicable |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GME751 |
GME751 Concentrate for solution for infusion, Biologic, Liquid in vial, 100 mg, 200 mg every 3 weeks , i.v. infusion Drug: Pemetrexed 500mg in 20 ml concentrate. Dose is 500 mg/m2 every 3 weeks (i.v. infusion) |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1. At least 18 years of age
2. Signed informed consent must be obtained prior to participation in the study
3. Participants of Study 101 or Study 301 who are judged to benefit from continued treatment with pembrolizumab by their Investigator.
4. Participants who have demonstrated compliance with Study 101 or Study 301 protocol requirements as assessed by their Investigator.
5. Participants who completed Study 101 or Study 301 as per protocol OR who discontinued treatment and consequently study participation in Study 101 or 301
6. Participants who discontinued from Study 301 based on Sponsor´s decision to terminate Study 301 |
|
| ExclusionCriteria |
| Details |
1. Participants who experienced disease recurrence during Study 101 or Study 301
2. Participants who experienced disease progression during Study 301.
3. Participants who experienced unacceptable toxicity related to pembrolizumab during Study 101 or Study 301.
4. Use of other investigational drugs after completion or discontinuation of Study 101 or 301.
5. Previously reported hypersensitivity reaction to any recombinant protein drugs or pemetrexed or any of the excipients used in GME751 and pemetrexed.
6. Received live vaccine less than or equal to 30 days before the first study treatment.
7. Pregnant (confirmed by urine or serum pregnancy test) or breastfeeding women.
8. Participants who withdrew consent of participation during 101 and 301. |
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To descriptively assess the safety of continued treatment with GME751, based on the occurrence of SAEs |
Cohort A (Melanoma): SAEs up to 6 to 12 months (End Of Study / Early Discontinuation) after start of treatment in Study 302
Cohort B (NSCLC): SAEs up to 12 to 24 months (End Of Study / Early Discontinuation) after start of treatment in Study 302
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Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
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Target Sample Size
|
Total Sample Size="1038"
Sample Size from India="9"
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)
|
01/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
|
Study 302 is a rollover study of Studies 101 and
301 with the purpose of providing continued pembrolizumab treatment to
participants who are eligible and have proven continued benefit from
pembrolizumab before being enrolled in Study 302. The pembrolizumab dosing in
Study
302 should continue to follow the schedule used in Study 101 or 301. To allow
for a seamless
transition into Study 302, screening and enrollment for Study 302 should
match with the EOS or ED visit in Study 101 or 301 and the participant’s
pembrolizumab dosing schedule. If EOS or ED visit of Study 101 or 301 cannot
be aligned to match the participant´s pembrolizumab dosing schedule, a
separate visit for the first GME751 administration in Study 302 should be
scheduled to maintain the treatment cycle of 3 or 6 weeks (e.g. if the ED
visit for a participant of Study 101 is scheduled 28±7 days after last
treatment, the first pembrolizumab dosing in Study 302 should only be
performed 6 weeks after last treatment i.e., 1-3 weeks after the scheduled ED
visit).
Information and assessments that have been
collected and performed for EOS/ED visit of Study 101 or 301 do not need to
be repeated at C1D1 of Study 302. Results from the EOS or ED assessments
(e.g. laboratory values, vital signs) in Study 101 or 301 can be re-used for
eligibility assessment in Study 302. Enrollment in Study 302 requires a
separate ICF. It must be signed before any assessment of Study 302 that is
not covered by the ICF of Study 101 or 301 is performed.
All participants will receive GME751 study
treatment regardless of prior exposure to Keytruda or GME751 in Study 101 or
301.
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