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RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors

This research study is looking at a new medicine called BMS-986340. It's being tested alone and in combination with other treatments like nivolumab, docetaxel, or Pumitamig. The main goal is to understand how safe it is, find the right dose, and see if it helps people with various advanced solid cancers, including cervical cancer, lung cancer, and melanoma. This is the very first time this new drug is being given to people, so researchers will be carefully observing its effects. The study is divided into two phases, Phase 1 and Phase 2, which helps researchers gradually learn more about the drug's safety and effectiveness.

At a glance

What is this study about?

This research study is about a new drug called BMS-986340. Doctors are trying to understand how safe it is and find the best amount (dose) to give to people with certain advanced cancers. These include cancers like cervical cancer, stomach cancer, lung cancer, head and neck cancer, kidney cancer, bladder cancer, pancreatic cancer, melanoma, ovarian cancer, and a type of breast cancer called triple-negative breast cancer. 'Advanced' means the cancer has spread or is difficult to treat with standard methods.

Researchers are looking at BMS-986340 in two ways: first, by itself (called monotherapy), and then combined with other existing treatments like nivolumab, docetaxel, or Pumitamig. Combining treatments sometimes can make them more effective. Since this is the very first time BMS-986340 is being given to people, the study will start by checking its safety and any side effects very carefully.

The information gathered from this study, especially about how safe the new drug is and what dose works best, will help decide if it can be studied further. The aim is to find new and potentially better ways to treat these advanced cancers when standard treatments haven't worked or aren't suitable.

Key takeaways

  • This study explores a new drug (BMS-986340) for advanced solid cancers.
  • It's the first time this drug is being tested in humans to check safety and dosage.
  • The drug may be given alone or combined with other cancer treatments.
  • Participation involves regular clinic visits, blood tests, scans, and possibly biopsies.
  • You can stop participating at any time.
  • Eligibility is strict, based on cancer type, previous treatments, and overall health.

Who may be eligible?

To be considered for this study, you would need to have certain advanced solid cancers that have progressed despite previous treatments. This usually means your cancer has continued to grow after standard care, or you can't have those treatments for some reason. The research team would need to take fresh tissue samples (biopsies) from your tumor before and during the study for analyses. Importantly, your cancer would need to be visible and measurable on scans, and at least one part of it should be easy to take a biopsy from.

There are also some important reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you have certain active or recent serious health conditions like specific heart problems, uncontrolled autoimmune diseases, or specific lung conditions. If you've had major surgery very recently, or if your cancer has spread to your brain in certain ways, you may also not be able to take part. The study also cannot include individuals who have been treated with certain other therapies too recently or those who have had a severe immune reaction to similar treatments in the past.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Is your cancer advanced and has it progressed after previous treatments?
  2. Are you able to provide fresh tumor tissue samples (biopsies)?
  3. Do you have a general good level of physical activity and well-being?
  4. Are you over 18 years old?
  5. Are you not pregnant or breastfeeding?
  6. Do you not have certain severe heart, lung, or autoimmune conditions?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new study medication, BMS-986340, sometimes alone and sometimes combined with other treatments. You would have regular visits to the clinic for check-ups, blood tests, and scans to see how you're responding and to monitor for any side effects. You might need to have new biopsies taken from your tumor during the study. The exact schedule of visits and tests would depend on which part of the study you are in and which treatment group you are assigned to. This study is generally for adults aged 18 and over. The total duration of your participation would be discussed with you by the research team, and it would involve ongoing monitoring and follow-up for a period after you stop taking the treatment.

Potential risks and benefits

Taking part in this study might offer a chance to try a new treatment that isn't widely available yet, which could potentially help your cancer. However, as with any new treatment, there are potential risks. The study drug, BMS-986340, could cause side effects, some of which might be serious or currently unknown. The research team would carefully monitor you for these and explain them in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (47)

  • Community Cancer Institute
    Verified postcode
    Clovis, United States· Recruiting
  • USC/Norris Comprehensive Cancer Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • Hoag Memorial Hospital Presbyterian
    Verified postcode
    Newport Beach, United States· Recruiting
  • University of Iowa
    Verified postcode
    Iowa City, United States· Recruiting
  • John Theurer Cancer Center
    Verified postcode
    Hackensack, United States· Recruiting
  • Local Institution - 0006
    Verified postcode
    New York, United States· Completed
  • Local Institution - 0002
    Verified postcode
    New York, United States· Completed
  • Providence Cancer Center Oncology and Hematology Care- Eastside
    Verified postcode
    Portland, United States· Recruiting
  • Local Institution - 0063
    Verified postcode
    Nashville, United States· Not yet recruiting
  • Vanderbilt University Medical Center
    Verified postcode
    Nashville, United States· Recruiting
  • Houston Methodist Hospital
    Verified postcode
    Houston, United States· Recruiting
  • Blacktown Hospital
    Verified postcode
    Blacktown, Australia· Recruiting

Common questions

What is BMS-986340?

BMS-986340 is a new drug being tested for advanced cancers. This is the first time it’s being given to people, so we are learning about its safety and effects.

What kind of cancers is this study for?

This study is for several types of advanced solid cancers, including cervical, stomach, lung, head and neck, kidney, bladder, pancreas, melanoma, ovarian, and triple-negative breast cancer.

Will I get the new drug by itself or with other medicines?

You might get BMS-986340 by itself, or it might be combined with other cancer treatments like nivolumab, docetaxel, or Pumitamig, depending on your situation and the study plan.

What does 'first-in-human' mean?

It means this is the first time this specific drug is being given to people. Researchers will be very carefully watching for any effects and side effects.

Can I stop participating in the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of BMS-986340 as Monotherapy and as Combination Ther…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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