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Study of BMS-986449 and Nivolumab for Patients with Advanced Solid Tumors

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What is this study about?

This clinical trial is focused on studying treatments for people with advanced solid tumors, which are types of cancer that have spread and are difficult to treat. The study involves two treatments: BMS-986449, a new medication taken as a capsule, and nivolumab, also known by its code name BMS936558, which is given through an infusion into a vein. The purpose of the study is to understand how safe and tolerable these treatments are when used alone or together in patients with advanced cancer.

Participants in the study will receive either BMS-986449 by itself or in combination with nivolumab. The study will monitor how the body responds to these treatments and any side effects that may occur. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments. The study will help researchers learn more about how these treatments work in the body and their potential benefits for people with advanced cancer.

The trial will take place over a period of time, during which participants will have regular check-ups and tests to monitor their health and the effects of the treatments. The information gathered from this study will contribute to understanding the potential of BMS-986449 and nivolumab as treatment options for advanced solid tumors, providing valuable insights for future cancer therapies.

1 enrollment and initial assessment

Upon joining the study, participants will undergo an initial assessment to confirm eligibility. This includes verifying age (18 years or older) and confirming the presence of an advanced, metastatic solid tumor.

A tumor biopsy will be required unless it is medically not possible.

2 treatment phase 1: monotherapy

Participants will receive BMS-986449 as a monotherapy. This medication is administered orally in the form of hard capsules.

The objective is to evaluate the safety and tolerability of BMS-986449 alone.

3 treatment phase 2: combination therapy

Participants will receive a combination of BMS-986449 and nivolumab. Nivolumab is administered intravenously as a solution for infusion.

The goal is to assess the safety and tolerability of the combination therapy.

4 monitoring and follow-up

Throughout the trial, participants will be monitored for any side effects or adverse events. This includes regular health check-ups and assessments.

The study will track the incidence of dose-limiting toxicities and other adverse events.

5 completion and final assessment

Upon completion of the treatment phases, a final assessment will be conducted to evaluate the overall health and response to the treatment.

The study is expected to conclude by May 21, 2025.

Who Can Join the Study?

  • Participants must be 18 years of age or older.
  • Participants must have a confirmed diagnosis of a locally advanced, unresectable, metastatic, or recurrent solid tumor. This means the cancer is in a stage that cannot be removed by surgery and may have spread to other parts of the body.
  • For Part 1A, participants can have any type of solid cancer. For Part 1B, only those with non-small cell lung cancer (NSCLC) can participate. For Part 1C, only those with triple-negative breast cancer (TNBC) can participate.
  • Participants must have already tried existing treatments that are known to help their condition, or they must be unable to receive these treatments due to ineffectiveness, ineligibility, or intolerance.
  • Participants must have measurable disease according to specific guidelines (RECIST v 1.1), which means the cancer can be measured in size to track changes during the study.
  • A tumor biopsy must be obtained from all participants unless it is not medically possible. A biopsy is a small sample of tissue taken from the tumor to study it more closely.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not reached the required age range for the study.
  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who are pregnant or breastfeeding.
  • Patients who have another serious health condition that could interfere with the study.
  • Patients who are taking certain medications that could affect the study results.
  • Patients who have had a recent surgery or medical procedure that could affect the study.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who have a history of substance abuse or alcohol dependency.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Institut Gustave Roussy Villejuif France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Netherlands Cancer Institute Amsterdam The Netherlands
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario Virgen De La Victoria Malaga Spain
Cluhgeeqd Ufigdjahfrrgrl Scagygshy Woluwe-Saint-Lambert Belgium
Alermvh Ozkvsmmhrsl Umsllvoredloe Sbhjqh Siena Italy
Caqwsz Lqzt Bookun Lyon France
Aaquelh Onktdhaxaoi Pjyc Gliwshdy Xrvgh Bergamo Italy
Uyjjxpzjpedq Mcbkejs Cepaxmo Gmigrpmhk Groningen The Netherlands
Hlqalyqm Uagcjtnvnyonx Hjstzdpo Tmahq y Pheqhe Iaenhaxh Csfash dxbdjrcdmwlmyqbmh (xzcg Badalona Spain
Iyfnunpx Pwwznngdoglipzm Cwypkq Ccslup Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
19.10.2023
France France
Not recruiting
19.10.2023
Italy Italy
Not recruiting
19.10.2023
Spain Spain
Not recruiting
19.10.2023
The Netherlands The Netherlands
Not recruiting
19.10.2023

Trial locations

Investigated drugs:

BMS-986449 is an experimental medication being studied for its safety and tolerability in people with advanced solid tumors. It is taken orally and is being tested both on its own and in combination with another medication to see how well it works and how safe it is for patients.

Nivolumab is a medication used to help the immune system fight cancer. In this study, it is being combined with BMS-986449 to see if the combination is more effective in treating advanced solid tumors than using BMS-986449 alone.

Advanced Metastatic Solid Malignancy – This condition refers to a type of cancer that has spread from its original site to other parts of the body, forming solid tumors. These tumors can develop in various organs and tissues, leading to a range of symptoms depending on their location and size. As the disease progresses, it can cause significant disruption to the normal function of affected organs. The spread of cancer cells, known as metastasis, is a key characteristic of this condition, making it more challenging to manage. The progression of the disease often involves the growth of new tumors in distant organs, which can complicate the clinical picture. Understanding the behavior of these malignancies is crucial for developing effective treatment strategies.

Trial ID:
2023-503484-42-00
Protocol code:
CA120-1001
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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