Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
176
Countries
2
Sites
8
Advanced and/or Metastatic Solid Tumors with Homozygous MTAP Deletion
Objective response (OR): to evaluate tumor response to BMS‑986504 in participants with advanced/metastatic solid tumors with MTAP gene deletion or MTAP loss. Examine how many participants have their tumors shrinking after treatment.
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]
- Decision date (initial)
- 2026-07-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Bristol-Myers Squibb Services Unlimited Company
External identifiers
- EU CT number
- 2025-524285-18-00
- WHO UTN
- U1111-1330-1428
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Efficacy, Dose response, Others, Pharmacodynamic
Objective response (OR): to evaluate tumor response to BMS‑986504 in participants with advanced/metastatic solid tumors with MTAP gene deletion or MTAP loss. Examine how many participants have their tumors shrinking after treatment.
Secondary objectives 5
- Time to objective response (TTOR): how long it takes for the tumors to start getting smaller after treatment
- Duration of response (DOR): how long the tumors stay smaller or gone after they respond
- Disease control (DC): how many participants have tumors that stay the same, get smaller, or disappear for a certain amount of time
- Clinical benefit (CB): how many participants get any kind of benefit from the study drug
- Safety: how safe BMS‑986504 is and how well participants can tolerate it
Conditions and MedDRA coding
Advanced and/or Metastatic Solid Tumors with Homozygous MTAP Deletion
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10027477 | Metastatic carcinoma | 10029104 |
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Histologically confirmed diagnosis of advanced and/or metastatic solid tumor with homozygous deletion of the MTAP gene confirmed
- Participant must be ≥ 18 years at the time of signing the ICF.
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system 8th edition
- Participants must have histologically confirmed advanced gastric (including gastroesophageal junction (GEJ)) adenocarcinoma or squamous esophageal cancer (SEC)
- Participants with histologically confirmed, surgically unresectable locally advanced or metastatic uroepithelial carcinoma that may be accompanied by other histologic differentiation
- Histologically-confirmed supratentorial glioblastoma
- Newly-diagnosed histologically-confirmed supratentorial glioblastoma (Grade IV malignant glioma by World Health Organization, including gliosarcoma)
- Histology confirmed Metastatic (Stage IV or recurrent) NSCLC
- Histologically or cytologically confirmed diagnosis of metastatic PDAC
Exclusion criteria 4
- Participants must not have spinal cord compression
- Participants must not have active brain metastases or leptomeningeal metastases
- History of gastrointestinal or non-gastrointestinal fistula, gastrointestinal perforation, or intraabdominal abscess
- Cardiac abnormalities including Left Venticular Ejection Fraction
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Achievement of OR- confirmed complete response (CR) or partial response (PR)
- To check how safe and tolerable different dose levels of BMS‑986504 are when it is given together with other cancer treatments in participants with advanced/metastatic tumor with MTAP gene deletion or MTAP loss.
Secondary endpoints 6
- TTOR- the time from first dose to the date of the first documentation of objective tumor response (CR or PR)
- DOR (CR or PR)- the time between the date of the first documentation of objective tumor response and the date of disease progression or to death from any cause (whichever occurs first)
- Achievement of DC- best overall response (BOR) of confirmed CR, confirmed PR, or stable disease (SD)
- Incidence and severity of adverse events (AEs), serious adverse events (SAEs), treatment related AEs and SAEs, AEs leading to study treatment discontinuation, deaths and laboratory abnormalities
- Achievement of CB- BOR of confirmed CR, confirmed PR, or SD for at least 4 months after start of treatment
- OR, DC, DOR, TTOR and CBof BMS-986504 in combination with other anti-cancer treatments
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 15
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 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
- INTRAVENOUS
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD12193680 · Product
- Active substance
- Navlimetostat
- Substance synonyms
- 2-[4-[4-(Aminomethyl)-1-oxo-2H-phthalazin-6-yl]-2-methylpyrazol-3-yl]-4-chloro-6-cyclopropyloxy-3-fluorobenzonitrile, MRTX-1719, BMS986504
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
SUB127678 · Substance
- Active substance
- Paclitaxel Albumin-Bound
- Pharmaceutical form
- POWDER FOR DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- 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
- INTRAVENOUS
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD13426964 · Product
- Active substance
- Pumitamig
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BIONTECH SE
- Paediatric formulation
- No
- Orphan designation
- No
PRD13426963 · Product
- Active substance
- Pumitamig
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BIONTECH SE
- Paediatric formulation
- No
- Orphan designation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07892MIG · Substance
- Active substance
- Gemcitabine
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(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
- Max daily dose
- 9999 mg/m2 milligram(s)/sq. meter
- Max total dose
- 9999 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be over-labeled and repackaged.
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 Blanchardstown Corporate Park 2
- 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 9
| Organisation | City, country | Duties |
|---|---|---|
| Iqvia Inc. ORG-100010622
|
Durham, United States | On site monitoring, Code 10, Code 11, Code 12, Code 2, Data management, Code 8, Code 9 |
| BioAgilytix Europe GmbH ORG-100016335
|
Hamburg, Germany | Other |
| Discovery Life Sciences Biomarker Services GmbH ORG-100042520
|
Kassel, Germany | Other |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Other |
| Mural Health Technologies Inc. ORG-100051510
|
Berwyn, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Foundation Medicine Inc. ORG-100040457
|
Boston, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management |
Locations
2 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 27 | 6 |
| Norway | Authorised, recruitment pending | 12 | 2 |
| Rest of world
Canada, Japan, United States, Korea, Republic of, Hong Kong, China
|
— | 137 | — |
Investigational sites
Universitaetsklinikum Wuerzburg AöR
Interdisziplinaeres Studienzentrum mit ECTU, Straubmuehlweg 2a, Grombuehl, Wuerzburg
Universitaetsklinikum Heidelberg AöR
Klinik für Medizinische Onkologie, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Klinik und Poliklinik fuer Innere Medizin, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Haematologie und Onkologie, Langenbeckstrasse 1, Oberstadt, Mainz
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Universitaet Leipzig
Universitaeres Krebszentrum Leipzig (UCCL), Liebigstrasse 22, Zentrum-Suedost, Leipzig
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 35 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-524285-18_Redacted | 1 |
| Protocol (for publication) | D1_Protocol 2025-524285-18_Redacted EU 01 | EU 01 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_NO | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements Germany | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Part 1_NO_no_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Part 2 Cohort 1_NO_no_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Part 2 Cohort 4_NO_no_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Part I GER_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Part II Cohort 1 GER_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Part II Cohort 4 GER_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample GER_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_NO_no_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_NO_no | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner-Participant GER_red | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Patient_NO_no | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PreScreening IC GER combined for CTA and PSA_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment beyond progression GER | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Paclitaxel | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Paclitaxel-Nab | 32 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cisplatin Accord IE | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Pemetrexed Accord | 15 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC Temozolomide | 25 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Gemcitabine powder Fresenius Kabi | n/a |
| Synopsis of the protocol (for publication) | D_PS1_Plan Synopsis CIV 26 02 056574 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2025-524285-18 EN | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2025-524285-18_FR | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2025-524285-18_IT | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis 2025-524285-18_IT_TC | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-524285-18_BE_DUT | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-524285-18_BE_FRE | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-524285-18_BE_GER | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-524285-18_NO | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2025-524285-18-00_TC | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES 2025-524285-18 | 3.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-16 | Germany | Acceptable with conditions 2026-07-06
|
2026-07-07 |