Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
145
Countries
3
Sites
20
Melanoma
The main objective in both groups is to see if participants prefer their drug to be given to them one way (SC) or the other way (IV).
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 19 Feb 2024 → ongoing
- Decision date (initial)
- 2024-01-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Bristol-Myers Squibb International Corporation
External identifiers
- EU CT number
- 2023-504515-33-00
- WHO UTN
- U1111-1289-5947
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others, Therapy
The main objective in both groups is to see if participants prefer their drug to be given to them one way (SC) or the other way (IV).
Secondary objectives 1
- The secondary objective in both groups is to test the safety of the drug in participants when they switch the treatment given in the vein (IV) to under the skin (SC).
Conditions and MedDRA coding
Melanoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10053571 | Melanoma | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- The study population will be made up of men and women (who are not pregnant or breastfeeding) 18 years of age or older that have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease. Participants must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma.
Exclusion criteria 1
- Participants must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body’s immune system response (immunosuppressive drugs).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The main endpoint in both groups is the percentage of participants who prefer having the treatment given as SC more than as IV.
Secondary endpoints 1
- The secondary endpoint in both groups is to see the side effects and abnormal laboratory tests during the study.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
OPDIVO 10 mg/mL concentrate for solution for infusion.
PRD2941375 · Product
- Active substance
- Nivolumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 480 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — -
- Marketing authorisation
- EU/1/15/1014/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10267387 · Product
- Active substance
- Nivolumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0000 mg milligram(s)
- Max total dose
- 0000 mg milligram(s)
- Max treatment duration
- 9999 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD9854659 · Product
- Active substance
- Nivolumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0000 mg milligram(s)
- Max total dose
- 0000 mg milligram(s)
- Max treatment duration
- 9999 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
FDC Nivolumab + Relatlimab + rHuPH20 Injection
PRD9863350 · Product
- Active substance
- Nivolumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0000 mg milligram(s)
- Max total dose
- 0000 mg milligram(s)
- Max treatment duration
- 9999 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254 Blanchardstown Corporate Park 2, Ballycoolin Ballycoolin
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Wilmington, United States | Other |
| Parexel International Corp. ORG-100007310
|
Durham, United States | Code 10 |
| Fortrea Development Ltd. Branch Of Foreign Company ORG-100049638
|
Maroussi, Greece | On site monitoring, Code 12, Code 2, Code 8 |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
| Fortrea Inc. ORG-100012602
|
Durham, United States | On site monitoring, Code 11, Code 12, Code 2, Code 8, Code 9 |
Locations
3 EU/EEA countries · 20 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Greece | Ongoing, recruitment ended | 31 | 6 |
| Italy | Ongoing, recruitment ended | 20 | 7 |
| Spain | Ongoing, recruitment ended | 31 | 7 |
| Rest of world
United States, Chile, Argentina
|
— | 63 | — |
Investigational sites
General Hospital Of Thessaloniki Papageorgiou
Department of Medical Oncology, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
Athens Medical Center S.A.
Oncology Department, Distomou 5-7, 151 25, Maroussi
Laiko General Hospital Of Athens
A' Department of Medicine, Sevastoupoleos 16, 115 26, Athens
Metropolitan Hospital
A' Oncology Clinic, Ethnarchi Makariou 11, 185 47, Pireas
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
5th Oncology, Leoforos Mesogeion 264, 155 62, Cholargos
Bioclinic S.A.
Oncology Department, Mitropoleos 86, 546 22, Thessaloniki
European Institute Of Oncology S.r.l.
Oncologia Medica del Melanoma, Sarcomi e Tumori rari, Via Giuseppe Ripamonti 435, 20141, Milan
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia clinica e sperimentale, Immunoterapia e Tumori rari, Via Piero Maroncelli 40, 47014, Meldola
Istituto Oncologico Veneto
Oncologia 2, Via Gattamelata 64, 35128, Padova
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Oncoematologia, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Dermatologia U, Via Cherasco 15, 10126, Turin
I.F.O. Istituti Fisioterapici Ospitalieri
Sarcomi e Tumori Rari, Via Elio Chianesi N 53, 00144, Rome
Azienda Ospedaliera Papa Giovanni XXIII
Oncologia, Piazza Oms 1, 24127, Bergamo
Institut Catala D'oncologia
Medical Oncology Service, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Marques De Valdecilla
Medical Oncolgy Service, Avenida Valdecilla Sn, 39008, Santander
University Hospital Virgen Del Rocio S.L.
Medical Oncolgy Service, Avenida De Manuel Siurot S/n, 41013, Sevilla
Institut Catala D'oncologia
Oncolgy Service, Carretera Canyet S/n, 08916, Badalona
University Clinical Hospital Virgen De La Arrixaca
Medical Oncology Service, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital De La Santa Creu I Sant Pau
Medical Oncology Service, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital San Pedro De Alcantara
Medical Oncology Service, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Greece | 2024-02-28 | 2024-03-28 | 2024-11-06 | ||
| Italy | 2024-02-29 | 2024-03-01 | 2024-11-06 | ||
| Spain | 2024-02-19 | 2024-02-21 | 2024-10-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 25 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-504515-33-00_GR_Greek_Redacted | PAM 02 |
| Protocol (for publication) | D1_Protocol_2023-504515-33-00_Redacted | 02 EU |
| Protocol (for publication) | D4_Patient facing documents_patient interview guide_EL_GR_not disclosed | NA |
| Protocol (for publication) | D4_Patient facing documents_patient interview guide_ES_ES_not disclosed | NA |
| Protocol (for publication) | D4_Patient facing documents_patient interview guide_IT_IT_not disclosed | NA |
| Protocol (for publication) | D4_Patient facing documents_PEPQ_EL_GR_not disclosed | NA |
| Protocol (for publication) | D4_Patient facing documents_PEPQ_ES_ES_not disclosed | NA |
| Protocol (for publication) | D4_Patient facing documents_PEPQ_IT_IT_not disclosed | NA |
| Protocol (for publication) | D4_Patient facing documents_PEQ_EL_GR_not disclosed | NA |
| Protocol (for publication) | D4_Patient facing documents_PEQ_ES_ES_not disclosed | NA |
| Protocol (for publication) | D4_Patient facing documents_PEQ_IT_IT_not disclosed | NA |
| Recruitment arrangements (for publication) | K1_GR_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K2_GR_Patient Info Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Info Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient brochure_IT | 1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF and SIS_IT_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_GR_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_Privacy ICF and SIS_IT | 3.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_EL_GR | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_EN | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_ES_ES | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_IT_IT | 2.0 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-13 | Italy | Acceptable 2024-01-15
|
2024-01-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-22 | Acceptable | 2024-05-13 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-02-22 | Italy | Acceptable | 2024-04-02 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-07-01 | Italy | Acceptable | 2024-07-01 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-10 | Acceptable | 2024-08-21 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-07-10 | Italy | Acceptable | 2024-08-14 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-15 | Acceptable | 2024-09-12 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-11-29 | Italy | Acceptable 2025-03-03
|
2025-03-04 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-05-05 | Italy | Acceptable 2025-03-03
|
2025-05-05 |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-10-16 | Italy | Acceptable 2025-12-01
|
2025-12-02 |