A Phase 1b/2 Study of BMS-986442 with Nivolumab with or without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer

2022-503108-26-00 Protocol CA115-001 Phase I and Phase II (Integrated) - First administration to humans Ended

Start 6 Nov 2023 · End 12 Sep 2024 · Status Ended · 3 EU/EEA countries · 14 sites · Protocol CA115-001

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - First administration to humans
Status Ended
Participants planned 245
Countries 3
Sites 14

Solid Tumor

To characterize the safety and tolerability, and to establish the MTD, MAD, and/or RP2D of BMS-986442 in combination with nivolumab or with nivolumab and chemotherapy

Key facts

Sponsor
Bristol-Myers Squibb Services Unlimited Company, 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
6 Nov 2023 → 12 Sep 2024
Decision date (initial)
2023-07-19
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2022-503108-26-00
WHO UTN
U1111-1283-1243

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Safety, Pharmacodynamic

To characterize the safety and tolerability, and to establish the MTD, MAD, and/or RP2D of BMS-986442 in combination with nivolumab or with nivolumab and chemotherapy

Secondary objectives 1

  1. To characterize the pharmacokinetics and immunogenicity, as well as assess the preliminary anti-tumor activity of BMS-combination with nivolumab or in combination with nivolumab and chemotherapy986442 administered in combination with nivolumab or in combination with nivolumab and chemotherapy

Conditions and MedDRA coding

Solid Tumor

VersionLevelCodeTermSystem organ class
21.1 PT 10061873 Non-small cell lung cancer 100000004864
21.1 LLT 10065252 Solid tumor 10029104

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  2. Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  3. Participants must have a life expectancy of at least 3 months at the time of first dose.

Exclusion criteria 3

  1. Untreated symptomatic central nervous system metastases or leptomeningeal metastases
  2. Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts
  3. Participants with an active, known, or suspected autoimmune disease. Other protocol-defined inclusion/exclusion criteria apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria
  2. AEs leading to discontinuation, and death (per CTCAE v5.0).

Secondary endpoints 2

  1. Summary measures of BMS-986442 PK parameters (such as, but not limited to, Cmax, Tmax, and AUC)
  2. Incidence of ADAs, and anti tumor efficacy parameters (ORR, DOR, DCR, and PFSR at 6 months and 12 months per RECIST v1.1 by Investigator)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

OPDIVO 10 mg/mL concentrate for solution for infusion.

PRD2941375 · Product

Active substance
Nivolumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
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

AGEN1777

PRD10286494 · Product

Active substance
BMS-986442
Substance synonyms
AGEN1777
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
IV INFUSION
Authorisation status
Not Authorised
MA holder
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
Paediatric formulation
No
Orphan designation
No

Comparator 4

Pemetrexed Disodium

SUB03669MIG · Substance

Active substance
Pemetrexed Disodium
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Docetaxel

SUB12492MIG · Substance

Active substance
Docetaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel

SUB09583MIG · Substance

Active substance
Paclitaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin

SUB06614MIG · Substance

Active substance
Carboplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
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

87 Total trials 43 Recruiting 35 Ended
Commercial
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

OrganisationCity, countryDuties
Pharmaceutical Product Development LLC
ORG-100016999
 Richmond, United States Other
Medidata Solutions Inc.
ORG-100016256
 New York, United States Other
Pharmaceutical Product Development LLC
ORG-100016999
 Highland Heights, United States Other
Flagship Biosciences Inc.
ORG-100043268
 Broomfield, United States Other
Iqvia Holdings Inc.
ORG-100043905
 Durham, United States Other
Accenture Solutions Private Limited
ORG-100032592
 Chennai, India Other
Accenture Solutions Private Limited
ORG-100032592
 Bangaluru, India Other, Data management
Accenture Solutions Private Limited
ORG-100032592
 Chennai, India Data management

Bristol-Myers Squibb Services Unlimited Company

87 Total trials 43 Recruiting 35 Ended
Commercial
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 5

OrganisationCity, countryDuties
Pharmaceutical Product Development LLC
ORG-100016999
 Richmond, United States Other
Medidata Solutions Inc.
ORG-100016256
 New York, United States Other
Flagship Biosciences Inc.
ORG-100043268
 Broomfield, United States Other
Iqvia Holdings Inc.
ORG-100043905
 Durham, United States Other
Accenture Solutions Private Limited
ORG-100032592
 Chennai, India Other

Locations

3 EU/EEA countries · 14 investigational sites

By country

CountryMS statusPlanned subjectsSites
Italy Ended 20 4
Poland Ended 50 4
Spain Ended 36 6
Rest of world
Australia, United States
 — 139 —

Investigational sites

Italy

4 sites · Ended
ASST Grande Ospedale Metropolitano Niguarda
Ematology, Oncology and Molecular Medicine, Piazza Dell'ospedale Maggiore 3, 20162, Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Melanoma, Cancer Immunotherapy and Development Therapeutics Unit, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliera Universitaria Senese
U.O.C. Immunoterapia Oncologica, Strada Delle Scotte 14, 53100, Siena
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Oncology, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo

Poland

4 sites · Ended
Centrum Onkologii Im Prof Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Instytut Centrum Zdrowia Matki Polki
Oddział Onkologii, Ul. Rzgowska 281/289, 93-338, Lodz
Uniwersyteckie Centrum Kliniczne
Ośrodek Badań Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Oddział Badań Wczesnych Faz, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw

Spain

6 sites · Ended
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya S/n, 29010, Malaga
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Italy 2023-11-06 2024-09-04 2023-11-30 2024-02-27
Spain 2023-11-16 2023-12-01

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

TitleSubmission dateStatusType
2022-503108-26-00_LPLV_CTIS results
SUM-67065
 2025-01-17T14:41:22 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
2022-503108-26-00_laypersons results summary 2025-01-08T16:43:17 Submitted Laypersons Summary of Results
Resumen en Lenguaje Sencillo de los Resultados 2025-02-13T10:12:02 Submitted Laypersons Summary of Results
2022-503108-26-00_Sintesi dei risultati in linguaggio semplice_IT 2025-03-06T14:26:35 Submitted Laypersons Summary of Results

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) 2022-503108-26-00_laypersons results summary 1
Laypersons summary of results (for publication) 2022-503108-26-00_Sintesi dei risultati in linguaggio semplice_IT 1
Laypersons summary of results (for publication) Plain Language Summary_ES 1
Summary of results (for publication) 2022-503108-26-00_Interim Results Blank Statement N/A

Application history

5 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-03-29 Poland Acceptable with conditions
2023-07-17
 2023-07-19
2 NON SUBSTANTIAL MODIFICATION NSM-1 2023-07-31 Acceptable with conditions
2023-07-17
 2023-07-31
3 SUBSTANTIAL MODIFICATION SM-1 2023-09-08 Poland Acceptable
2023-11-30
 2023-12-01
4 NON SUBSTANTIAL MODIFICATION NSM-2 2024-04-22 Acceptable
2023-11-30
 2024-04-22
5 NON SUBSTANTIAL MODIFICATION NSM-3 2024-07-23 Poland Acceptable
2023-11-30
 2024-07-23

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