Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
196
Countries
5
Sites
24
Non-small Cell Lung Cancer
Part 1: Safety Lead-in Assess the safety of BMS-986315 administered in combination with nivolumab and histology-based platinum doublet chemotherapy (PDCT). Part 2: Primary Compare the anti-tumor activity, specifically the objective response rate (ORR) of BMS-986315 and nivolumab in combination with PDCT versus nivolum…
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
- completed 8 Aug 2024
- Decision date (initial)
- 2024-01-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Bristol-Myers Squibb Services Unlimited Company
External identifiers
- EU CT number
- 2022-503007-22-00
- WHO UTN
- U1111-1282-5699
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Safety, Therapy, Pharmacogenomic, Pharmacogenetic, Dose response, Others, Pharmacodynamic
Part 1: Safety Lead-in Assess the safety of BMS-986315 administered in combination with nivolumab and histology-based platinum doublet chemotherapy (PDCT).
Part 2: Primary Compare the anti-tumor activity, specifically the objective response rate (ORR) of BMS-986315 and nivolumab in combination with PDCT versus nivolumab and PDCT.
Secondary objectives 1
- Part 2: Further assess preliminary anti-tumor activity, such as progression-free survival (PFS), as well as characterize the pharmacokinetics (PK or how the body interacts with the drug after its administration, through the mechanisms of absorption, distribution, metabolism, and excretion) and the immunogenicity (the ability of a drug to provoke an immune response) of BMS-986315.
Conditions and MedDRA coding
Non-small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10029522 | Non-small cell lung cancer stage IV | 100000004864 |
| 21.1 | PT | 10029515 | Non-small cell lung cancer recurrent | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Male and female participants must be ≥ 18 years of age or local age of majority at the time of signing the informed consent. Participants must have NSCLC with Stage IV or recurrent disease following multimodal therapy for locally advanced disease. Study treatment must be first-line therapy for Stage IV or recurrent disease. Participants in all parts of the study must have measurable disease per RECIST v1.1; an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; and a life expectancy of at least 3 months at the time of first dose.
Exclusion criteria 1
- Exclusion Criteria (All Study Parts): Untreated symptomatic central nervous system metastases. Participants with EGFR/ALK/ROS1/NTRK/MET/BRAF/RET mutations amenable to targeted therapies. Participants with any known medical condition that, in the investigator’s opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Part 1: Main endpoints include incidence of all adverse events (AEs), including AEs leading to discontinuation, and death (per CTCAE v5.0).
- Part 2: Main endpoint is the Objective Response Rate (ORR) assessed by BICR (a blinded independent central review committee).
Secondary endpoints 1
- Part 2: Secondary endpoints include summary measures of BMS-986315 PK parameters and additional anti-tumor efficacy parameters, such as PFS, by BICR.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10592788 · Product
- Active substance
- BMS-986315
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 5
OPDIVO 10 mg/mL concentrate for solution for infusion.
PRD2941375 · Product
- Active substance
- Nivolumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 360 mg milligram(s)
- Max total dose
- 11520 mg milligram(s)
- Max treatment duration
- 24 Month(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
SUB09583MIG · Substance
- Active substance
- Paclitaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 800 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 900 mg/m2 milligram(s)/square meter
- Max total dose
- 3600 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03669MIG · Substance
- Active substance
- Pemetrexed Disodium
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 16000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 300 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- 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 |
|---|---|---|
| Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Syneos Health Netherlands B.V. ORG-100013861
|
Amsterdam, Netherlands | On site monitoring, Code 12, Code 2, Code 8 |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Other, Data management |
| National Genetics Institute ORG-100039148
|
Los Angeles, United States | Other, Laboratory analysis |
| Q Squared Solutions Holdings LLC ORG-100043288
|
Valencia, United States | Other, Laboratory analysis |
Locations
5 EU/EEA countries · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 13 | 5 |
| Italy | Ended | 10 | 5 |
| Poland | Ended | 27 | 5 |
| Romania | Ended | 23 | 3 |
| Spain | Ended | 22 | 6 |
| Rest of world
Brazil, United States, Australia, Chile, Argentina
|
— | 101 | — |
Investigational sites
Centre Hospitalier De Saint-Quentin
Department of Pneumology, 1 Rue Michel De L Hospital, 02100, Saint Quentin
Centre Hospitalier Universitaire Grenoble Alpes
Thoracic Oncology Unit, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Caen Normandie
Pneumology department, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Institut De Cancerologie De L Ouest
Medical oncology, Bd Du Professeur Jacques Monod, 44800, St Herblain
Institut Curie
Thoracic Oncology Unit, 26 Rue D Ulm, 75005, Paris
Fondazione Policlinico Universitario Campus Bio-Medico
Medical Oncology, Via Alvaro Del Portillo N 200, 00128, Rome
Azienda Ospedaliero Universitaria Parma
Medical Oncology, Viale Antonio Gramsci 14, 43126, Parma
I.F.O. Istituti Fisioterapici Ospitalieri
Oncology - Clinical trial center phase I, Via Elio Chianesi N 53, 00144, Rome
Hospital Santa Maria Della Misericordia
SC Oncologia Medica, Piazzale Giorgio Menghini 1, 06129, Perugia
Ospedale San Raffaele S.r.l.
UOC Oncologia Medica, Via Olgettina 60, 20132, Milan
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Oncology, Os. Zlotej Jesieni 1, 31-826, Cracow
Uniwersyteckie Centrum Kliniczne
Oncology, Ul. Debinki 7, 80-952, Gdansk
Uniwersytecki Szpital Kliniczny W Bialymstoku
Oncology, Zurawia 14, 15-540, Bialystok
Instytut Centrum Zdrowia Matki Polki
Oncology, Ul. Rzgowska 281/289, 93-338, Lodz
Med Polonia Sp. z o.o.
Oncology, Obornicka 262, 60-693, Poznan
Medisprof S.R.L.
Medical Oncology, Bulevardul Muncii 96, 400641, Cluj-Napoca
Centrul De Oncologie SF Nectarie S.R.L.
Medical Oncology, Strada Caracal Nr 109, 200542, Craiova
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Medical Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinico Universitario Lozano Blesa
Medical Oncology, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitari Vall D Hebron
Medical Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Regional De Malaga
Medical Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga
Institut Catala D'oncologia
Medical Oncology, Carretera Canyet S/n, 08916, Badalona
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| 2022-503007-22-00_Summary of Results SUM-76924
|
2025-03-28T14:30:11 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| 2022-503007-22-00_Lay person summary of results | 2025-03-27T09:23:04 | Submitted | Laypersons Summary of Results |
| 2022-5030007-22-00_Lay Person Summary of Results_ES | 2025-04-09T16:05:11 | Submitted | Laypersons Summary of Results |
| CA047-1009-pls-en-final_it-IT | 2025-07-28T11:09:30 | Submitted | Laypersons Summary of Results |
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | 2022-5030007-22-00_Lay Person Summary of Results_ES | 1 |
| Laypersons summary of results (for publication) | 2022-503007-22-00_Lay person summary of results | N/A |
| Laypersons summary of results (for publication) | CA047-1009-pls-en-final_it-IT | 1 |
| Summary of results (for publication) | 2022-503007-22-00_Summary of Results | N/A |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-15 | France | Acceptable 2024-01-22
|
2024-01-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-02-01 | Acceptable 2024-01-22
|
2024-02-01 |