A Study of BMS-986504 Combined with Nab-Paclitaxel and Gemcitabine for Patients with Untreated Metastatic Pancreatic Cancer with MTAP Gene Deletion

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What is this study about?

This study involves people with pancreatic ductal adenocarcinoma that has spread to other parts of the body and has not been treated yet. Pancreatic ductal adenocarcinoma is a type of cancer that starts in the pancreas, an organ that helps with digestion and blood sugar control. The study specifically looks at tumors that have a particular genetic change called homozygous MTAP deletion, which means a specific gene is missing in both copies within the cancer cells. The treatments being studied include BMS-986504, which is also known as MRTX1719, along with two other cancer medicines called nab-paclitaxel and gemcitabine. Some people in the study will receive BMS-986504 combined with nab-paclitaxel and gemcitabine, while others will receive placebo combined with nab-paclitaxel and gemcitabine. BMS-986504 is given as a tablet by mouth, while nab-paclitaxel and gemcitabine are given through a vein.

The purpose of the study is to test whether BMS-986504 combined with nab-paclitaxel and gemcitabine can help people live longer and delay the time until the cancer gets worse compared to placebo combined with nab-paclitaxel and gemcitabine. The study will also look at whether the combination treatment can shrink tumors and control tumor growth. People joining the study must have their cancer confirmed through tissue samples and must have evidence of the MTAP deletion in their tumor. The cancer must have spread to other parts of the body with at least one area that can be measured on scans.

During the study, people will be randomly assigned to receive either BMS-986504 or placebo, both given together with nab-paclitaxel and gemcitabine. The study will track how long it takes for the cancer to worsen on scans and how long people survive. Researchers will also measure how much tumors shrink, how long any shrinkage lasts, and how many people experience tumor control or shrinkage. People in the study must not have received any cancer treatment for their spread disease before joining, although they may have received up to one cycle of nab-paclitaxel and gemcitabine before being assigned to a treatment group.

1 Random assignment to treatment group

Upon joining the study, you will be randomly assigned to one of two treatment groups. This process is similar to flipping a coin and ensures fairness in the study.

One group will receive BMS-986504 (also called MRTX1719) combined with nab-paclitaxel (a protein-bound form of the chemotherapy drug paclitaxel) and gemcitabine (another chemotherapy drug).

The other group will receive a placebo (an inactive substance with no medication) combined with nab-paclitaxel and gemcitabine.

You will not know which group you are assigned to during the study.

2 Receiving oral medication

You will take either BMS-986504 tablets or placebo tablets by mouth, depending on your assigned group.

The tablets are film-coated, which means they have a smooth outer layer for easier swallowing.

You will need to take these tablets according to the schedule provided by the study staff.

3 Receiving intravenous chemotherapy

Regardless of your group assignment, you will receive two chemotherapy medications through a vein: nab-paclitaxel and gemcitabine.

Nab-paclitaxel is a form of paclitaxel that is bound to albumin, a protein that helps deliver the medication to cancer cells.

Gemcitabine is a chemotherapy drug that interferes with cancer cell growth.

These medications will be administered by infusion into your vein at the study site.

4 Regular monitoring and assessments

Throughout the study, you will undergo regular medical assessments to monitor your condition and response to treatment.

Imaging scans will be performed periodically to evaluate whether the cancer is growing, shrinking, or staying the same size.

These assessments help determine the effectiveness of the treatment and monitor for any changes in your disease.

5 Continuation of treatment

You will continue receiving the assigned treatment combination according to the study protocol.

The duration of treatment will depend on how your body responds to the therapy and whether your disease remains stable or improves.

Treatment may continue for an extended period as long as it is beneficial and tolerable for you.

6 Study completion

The study is expected to continue until approximately May 2029.

Your participation may end earlier or later depending on your individual response to treatment and overall health status.

Final assessments will be conducted to evaluate the overall outcomes of the treatment you received.

Who Can Join the Study?

To join this clinical trial, you must meet all of the following requirements:

You must have a confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma, which means cancer that started in the tubes of the pancreas and has spread to other parts of the body. This diagnosis must be confirmed by examining tissue or cells under a microscope.
Your tumor tissue must show a specific genetic change called homozygous MTAP deletion or MTAP loss. This means that both copies of a particular gene called MTAP are missing or not working in your cancer cells.
You must have cancer that has spread to other parts of the body with at least one tumor that can be measured on scans according to specific measurement rules called RECIST v1.1.
You must not have received any previous cancer treatment for your cancer that has spread, meaning this would be your first treatment for the advanced disease. However, you may have received up to one cycle of standard treatment with nab-paclitaxel and gemcitabine, which are chemotherapy medicines, before joining the study.
You must be older than 18 years of age at the time you sign the consent form to participate in the study.

Who Cannot Join the Study?

The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
Without detailed exclusion criteria information, it is not possible to list specific conditions or situations that would prevent participation in this clinical trial
Typically, exclusion criteria may include things like other serious medical conditions, certain medications being taken, previous treatments, or laboratory test results that fall outside acceptable ranges, but these specific details are not available in the provided information

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Medical University Of Vienna	Vienna	Austria
DRK Kliniken Berlin	Berlin	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
University Hospital Maastricht	Maastricht	The Netherlands
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Istituto Oncologico Veneto	Padua	Italy
F D Roosevelt University General Hospital Of Banska Bystrica	Banska Bystrica	Slovakia
Institut Jules Bordet	Anderlecht	Belgium
General University Hospital Of Larissa	Larissa	Greece
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Hospital Unviersitario Miguel Servet	Zaragoza	Spain
Spitalul Clinic Coltea	Bucharest	Romania
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Institutul Regional De Oncologie Iasi	Iasi	Romania
Fakultni Thomayerova nemocnice	Prague	Czechia
Virgen del Rocío University Hospital	Sevilla	Spain
Odense University Hospital	Odense	Denmark
Ospedale San Raffaele S.r.l.	Milan	Italy
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Alexandra Hospital	Athens	Greece
Hospital Clinic De Barcelona	Barcelona	Spain
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Karolinska University Hospital	Solna	Sweden
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Centre Hospitalier De La Cote Basque	Bayonne	France
Pratia S.A.	Skorzewo	Poland
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
University Hospital Olomouc	Olomouc	Czechia
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre hospitalier universitaire de Liege	Liege	Belgium
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Universitair Ziekenhuis Gent	Gent	Belgium
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hopital Beaujon	Clichy	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Amphia Hospital	Breda	The Netherlands
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj	Cluj Napoca	Romania
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Mtz Clinical Research Powered By Pratia	Warsaw	Poland
Radiotherapy Center Cluj S.R.L.	Floresti	Romania
University General Hospital Of Heraklion	Heraklion	Greece
Vychodoslovensky Onkologicky Ustav a.s.	Kosice	Slovakia
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Spitalul Municipal Ploiesti	Ploiesti	Romania
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Uniklinikum Salzburg	Salzburg	Austria
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Norddeutsches Studienzentrum für Innovative Onkologie (NIO)	Hamburg	Germany
Fundeni Clinical Institute	Bucharest	Romania
Coqwchdke Upucavbthrsmfv Savxmtsaq	Woluwe-Saint-Lambert	Belgium
Iechcgtw Rpwyawor Da Cpbznd Dm Mqyieiynhlq	Montpellier	France
Tyegrbmhps Cwodbe Hhmqibfj	Thessaloniki	Greece
Nbgdqbpa Ordlpbiz Iyhtsbfwq	Bratislava	Slovakia
Ihospwop Pvvjazkgmjyxtva Cgoocb Clktsq	Marseille	France
Hwefspqg Verw dkgorvjg	Barcelona	Spain
Uplnlmjqfe Hvfibpor Cxvvxtu	Cologne	Germany
Fwgelwkw noiakzgyp Mcfim a Hcnumui	Prague	Czechia
Hucrkt Hsdhhsuf	Herlev	Denmark
Itmtqreu Rmqnxalpa Pih Lc Soevby Dhy Tyrunr Djot Aevqtcf Ioog Swxmfz	Meldola	Italy
Ukpksjq Uvzuzfxusn Hfwcmazf	Uppsala	Sweden
Bvjonnxs Uoloqpwuya Hyaznfgi Crafsp	Besançon	France
Exaajty Ucxocsuzvrkk Mxkolpu Ckmcbmm Rxknqycfk (cqyrkwz Mkb	Rotterdam	The Netherlands
Clqs Dh Ntaba	Vandoeuvre Les Nancy	France
Avmlrb Muvpspt Cjxozn Sycp	Thessaloniki	Greece
Abwspqm Hhzizidw	Athens	Greece
Sw Viuzsznuqbrirlj Uryfjzsgyy Hllddtoh	Dublin	Ireland
Ucnyutfcnq Ov Acmrgpd	Edegem	Belgium
Ockdtmzyhvulfb Lvgl Gfuw	Linz	Austria
Lqelw Uslepgrrotsb Mbfwstt Coxgqhi (pwzvk	Leiden	The Netherlands
Imntjj	Bonheiden	Belgium

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.12.2025
Belgium	Not recruiting	01.12.2025
Czechia	Not recruiting	01.12.2025
Denmark	Not recruiting	01.12.2025
France	Not recruiting	01.12.2025
Germany	Not recruiting	01.12.2025
Greece	Recruiting	01.12.2025
Ireland	Recruiting	01.12.2025
Italy	Not recruiting	01.12.2025
Poland	Not recruiting	01.12.2025
Romania	Not recruiting	01.12.2025
Slovakia	Not yet recruiting	01.12.2025
Spain	Not recruiting	01.12.2025
Sweden	Not recruiting	01.12.2025
The Netherlands	Recruiting	01.12.2025

Trial locations

Investigated drugs:

BMS-986504 is an investigational medication being tested in combination with other cancer drugs. This medication is specifically being studied for patients with a certain type of pancreatic cancer that has a specific genetic characteristic called homozygous MTAP deletion. The purpose of testing this medication is to see if it can help slow down the growth and spread of cancer and help patients live longer when used together with other treatments.

Nab-paclitaxel is a chemotherapy medication used to treat various types of cancer, including pancreatic cancer. It works by stopping cancer cells from dividing and growing. This medication is delivered in a special form that uses tiny particles to help the drug reach cancer cells more effectively.

Gemcitabine is a chemotherapy medication commonly used to treat pancreatic cancer and other types of cancer. It works by interfering with the growth of cancer cells, which slows down or stops their spread in the body. This medication is often used in combination with other cancer treatments.

Metastatic Pancreatic Ductal Adenocarcinoma – This is a type of cancer that starts in the cells lining the ducts of the pancreas, an organ located behind the stomach that helps with digestion and blood sugar control. The cancer begins when cells in these ducts start growing abnormally and uncontrollably. As the disease progresses, the cancer cells spread beyond the pancreas to other parts of the body, such as the liver, lungs, or distant lymph nodes, which is called metastasis. This spreading occurs through the bloodstream or lymphatic system. The tumor can grow larger in the pancreas itself while also forming new tumors in distant organs. Symptoms may include abdominal pain, weight loss, jaundice (yellowing of the skin and eyes), loss of appetite, and digestive problems as the disease advances.

Trial ID:

2025-522598-12-00

Protocol code:

CA240-0030

Trial Phase:

Therapeutic use (Phase IV)

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A Study of BMS-986504 Combined with Nab-Paclitaxel and Gemcitabine for Patients with Untreated Metastatic Pancreatic Cancer with MTAP Gene Deletion

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?