Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
311
Countries
3
Sites
16
Advanced solid tumors (squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), cutaneous melanoma, triple-negative breast cancer (TNBC), renal cell carcinoma (RCC), urothelial carcinoma, gastric, esophageal, cervical, and colorectal cancer (CRC)).
For Part 1, 2A, 2B: To characterize the safety, tolerability, and Dose-Limiting Toxicities (DLTs) and to determine the Maximum Tolerated Dose (MTD)/ Recommended Phase 2 Dose (RP2D) of BMS-986288 administered as monotherapy and in combination with nivolumab in participants with select advanced solid tumors. For Part 2C:…
Key facts
- Sponsor
- Bristol Myers Squibb International Corporation
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 11 May 2022 → 31 Aug 2024
- Decision date (initial)
- 2024-01-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508954-25-00
- EudraCT number
- 2021-004284-27
- WHO UTN
- U1111-1247-3650
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenomic, Efficacy, Pharmacogenetic, Pharmacodynamic, Pharmacokinetic, Safety
For Part 1, 2A, 2B:
To characterize the safety, tolerability, and Dose-Limiting Toxicities
(DLTs) and to determine the Maximum Tolerated Dose (MTD)/
Recommended Phase 2 Dose (RP2D) of BMS-986288 administered as
monotherapy and in combination with nivolumab in participants with
select advanced solid tumors.
For Part 2C:
To compare the efficacy of BMS-986288 in combination with nivolumab
vs regorafenib in the 3L/4L MSS CRC setting.
Secondary objectives 4
- For Part 1, 2A, 2B: To characterize the Pharmacokinetic (PK) of BMS-986288 when administered alone and in combination with nivolumab
- For Part 1, 2A, 2B: To assess the preliminary efficacy of BMS-986288 alone and in combination with nivolumab in advanced solid tumors using RECIST v1.1
- For Part 2C: To compare the efficacy of BMS-986288 in combination with nivolumab vs regorafenib in the 3L/4L MSS CRC setting
- For Part 2C: To characterize the safety and tolerability of BMS-986288 in combination with nivolumab vs regorafenib in the 3L/4L MSS CRC setting
Conditions and MedDRA coding
Advanced solid tumors (squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), cutaneous melanoma, triple-negative breast cancer (TNBC), renal cell carcinoma (RCC), urothelial carcinoma, gastric, esophageal, cervical, and colorectal cancer (CRC)).
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies
Exclusion criteria 3
- Participants with active, known or suspected autoimmune disease
- Participants with other active malignancy requiring concurrent intervention
- Participants with primary CNS malignancies or tumors with CNS metastasis as the only site of disease, will be excluded
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- For Part 1, 2A, 2B: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs meeting protocol-defined Dose Limiting Toxicities (DLT) Criteria, AEs leading to discontinuation, death and laboratory abnormalities
- For Part 2C: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by BICR
Secondary endpoints 19
- For Part 1, 2A, 2B: Maximum Observed Concentration (Cmax) of BMS-986288
- For Part 1, 2A, 2B: Time of Maximum Observed Concentration (Tmax) of BMS-986288
- For Part 1, 2A, 2B: Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288
- For Part 1, 2A, 2B: Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288
- For Part 1, 2A, 2B: Observed Concentration at the end of a Dosing Interval (Ctau) of BMS- 986288
- For Part 1, 2A, 2B: Trough Observed Concentrations (Ctrough) of BMS-986288
- For Part 1, 2A, 2B: Total Body Clearance (CLT) of BMS-986288
- For Part 1, 2A, 2B: Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288
- For Part 1, 2A, 2B: Accumulation Index (AI) of BMS-986288
- For Part 1, 2A, 2B: Terminal Half-Life (T-HALF) of BMS-986288
- For Part 1, 2A, 2B: Objective Response Rate (ORR) of Participants
- For Part 1, 2A, 2B: Duration of Response (DOR) of Participants
- For Part 1, 2A, 2B: Progression-Free Survival (PFS) of Participants
- For Part 1, 2A, 2B: Time to Response (TTR) of Participants
- For Part 2C: Objective Response Rate (ORR) by RECIST V1.1 by BICR
- For Part 2C: Duration of Response (DOR) by RECIST V1.1 by BICR
- For Part 2C: Progression-Free Survival (PFS) by RECIST V1.1 by BICR
- For Part 2C: Overall Survival (OS) by RECIST V1.1 by BICR
- For Part 2C: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs meeting protocol-defined Dose Limiting Toxicities (DLT) Criteria, AEs leading to discontinuation and death.
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
- Substance synonyms
- BMS936558, ABP 206
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- 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
PRD10942669 · Product
- Active substance
- BMS-986288
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
Stivarga 40 mg film-coated tablets
PRD1713388 · Product
- Active substance
- Regorafenib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01XE21 — -
- Marketing authorisation
- EU/1/13/858/002
- MA holder
- BAYER AG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol Myers Squibb International Corporation
- Sponsor organisation
- Bristol Myers Squibb International Corporation
- Address
- Terhulpsesteenweg 185
- City
- Watermaal-Bosvoorde
- Postcode
- 1170
- Country
- Belgium
Scientific contact point
- Organisation
- Bristol Myers Squibb International Corporation
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol Myers Squibb International Corporation
- Contact name
- GSM-CT
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Icon Laboratory Services Inc. ORG-100037135
|
Farmingdale, United States | Other, Laboratory analysis |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Other |
Locations
3 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 25 | 5 |
| Italy | Ended | 21 | 5 |
| Spain | Ended | 50 | 6 |
| Rest of world
Argentina, Chile, Canada, United States
|
— | 215 | — |
Investigational sites
Institut Curie
Insititut du Thorax/Departement Oncologie medicale, 26 Rue D Ulm, 75005, Paris
Assistance Publique Hopitaux De Marseille
Hôpital Timone_Service Oncologie Medicale et Oncologie Digestive, 264 Rue Saint Pierre, 13005, Marseille
Hospices Civils De Lyon
Hôpital cardiologie Louis Pradel_Service de Pneumologie, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire De Bordeaux
Hôpital Saint-André_Service d'oncologie médicale, 1 Rue Jean Burguet, 33000, Bordeaux
CHU Nantes
Unité d'Oncologie Thoracique, Boulevard professeur Jacques Monod, 44093, Nantes
ASST Grande Ospedale Metropolitano Niguarda
Oncologia Falck, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Istituto Oncologico Veneto
Oncologia Medica 1, Via Gattamelata 64, 35128, Padova
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Fase 1, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliero Universitaria Delle Marche
Clinica Oncologica, Via Conca 71, 60126, Ancona
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Oncology, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Vall D'hebron Institut De Recerca
Oncology, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
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 |
|---|---|---|---|---|---|
| France | 2022-05-11 | 2024-05-14 | 2022-06-22 | 2024-03-01 | |
| Italy | 2022-08-02 | 2024-08-20 | 2022-08-09 | 2024-03-01 | |
| Spain | 2022-05-18 | 2022-06-16 | 2024-03-01 |
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
| Title | Submission date | Status | Type |
|---|---|---|---|
| 2023-508954-25-00_Final Summary of Results SUM-95853
|
2025-08-29T15:03:49 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| 2023-508954-25-00_Lay Persons Summary of Results | 2025-08-29T15:16:09 | Submitted | Laypersons Summary of Results |
| 2023-508954-25-00_Lay Persons Summary of Results_ES | 2025-09-09T12:09:39 | Submitted | Laypersons Summary of Results |
| 2023-508954-25-00_Lay Persons Summary of Results_FR | 2025-11-21T20:19:44 | Submitted | Laypersons Summary of Results |
| 2023-508954-25-00_Lay Persons Summary of Results_IT | 2025-12-15T15:07:25 | Submitted | Laypersons Summary of Results |
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | 2023-508954-25-00_Lay Persons Summary of Results | N/A |
| Laypersons summary of results (for publication) | 2023-508954-25-00_Lay Persons Summary of Results_ES | NA |
| Laypersons summary of results (for publication) | 2023-508954-25-00_Lay Persons Summary of Results_FR_22Aug2025 | 1 |
| Laypersons summary of results (for publication) | 2023-508954-25-00_Lay Persons Summary of Results_IT | NA |
| Protocol (for publication) | D1_Protocol 2023-508954-25-00_redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Stivarga | 1 |
| Summary of results (for publication) | 2023-508954-25-00_Final Summary of Results | N/A |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-15 | Spain | Acceptable 2024-01-16
|
2024-01-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-05-13 | Spain | Acceptable 2024-01-16
|
2024-05-13 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-06-19 | Spain | Acceptable 2024-01-16
|
2024-06-19 |