Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid Tumors

This research study is investigating new ways to treat several advanced or metastatic cancers, including triple-negative breast cancer, stomach cancer, pancreatic cancer, small cell lung cancer, bladder cancer, and ovarian cancer. The study is particularly interested in a medicine called nivolumab, which is used either by itself or together with another drug called ipilimumab. Researchers want to find out how effective these treatments are at shrinking tumors. They will also be closely monitoring any side effects people experience and how long people live without their cancer getting worse or in total. This is an early-stage study, meaning it's one of the first times these specific treatments are being studied in a larger group of people with these cancers.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Bristol Myers Squibb International Corporation

Enrolment target

Start

12 Sep 2024

What is this study about?

This study is designed to explore new treatment options for people who have advanced or metastatic cancer. This means the cancer has either grown significantly or spread to other parts of the body. The study focuses on several specific types of cancer, including a type of breast cancer called triple-negative, stomach cancer, pancreatic cancer, a type of lung cancer known as small cell, bladder cancer, and ovarian cancer.

The main aim is to see how well a medicine called nivolumab works. This drug will be given either alone or combined with another drug called ipilimumab. Both of these medicines work with your body's immune system to help it fight cancer. Researchers will carefully measure how many people's tumors shrink or disappear completely after receiving these treatments.

Beyond just tumor shrinkage, the study will also look at other important details. This includes how long people live without their cancer getting worse (called 'progression-free survival') and overall how long people live ('overall survival'). They will also be very keen to understand any side effects that people experience from these treatments, especially those that might lead to someone stopping the medication. This information helps doctors understand if the treatments are not only effective but also safe for patients.

Key takeaways

This study explores new treatments for specific advanced cancers.
It tests nivolumab, alone or with ipilimumab, to fight cancer.
Researchers will check how much tumors shrink and for side effects.
It's open to adults aged 18 and over with certain advanced cancers.
Participation involves regular clinic visits for treatment and checks.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. There is no upper age limit, meaning older adults can also take part.

This study is open to both men and women. If you have been diagnosed with advanced or metastatic triple-negative breast cancer, stomach cancer, pancreatic cancer, small cell lung cancer, bladder cancer, or ovarian cancer, you might be eligible.

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.

Are you 18 years old or older?
Do you have advanced or metastatic triple-negative breast cancer?
Do you have advanced or metastatic stomach (gastric) cancer?
Do you have advanced or metastatic pancreatic cancer?
Do you have advanced or metastatic small cell lung cancer?
Do you have advanced or metastatic bladder cancer?
Do you have advanced or metastatic ovarian cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either nivolumab alone or nivolumab combined with ipilimumab through a drip (infusion). You will have regular visits to the clinic so the medical team can monitor your health, check for any side effects, and see how the treatment is working. This will involve physical examinations, blood tests, and scans. The exact number of visits and tests will be explained to you by the study team. You will also have follow-up appointments after your treatment finishes to continue monitoring your health. The total time you spend in the study will depend on how you respond to the treatment and the study's schedule.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to new treatments that aren't widely available yet, which could help your cancer. However, there are also potential risks; the medicines might have side effects, some of which could be serious or unexpected. Your doctors will explain all known side effects and what to expect. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What kind of cancers is this study looking at?

This study is for advanced or metastatic triple-negative breast cancer, stomach cancer, pancreatic cancer, small cell lung cancer, bladder cancer, and ovarian cancer.

What are the treatments being tested?

The study is testing nivolumab by itself, or nivolumab combined with ipilimumab.

What does 'advanced or metastatic' mean?

It means the cancer has grown significantly or has spread from where it started to other parts of your body.

What are the researchers hoping to learn?

They want to see how well the treatments shrink tumors, their side effects, and how they affect how long people live.

Can anyone join this study?

You must be at least 18 years old and have one of the specific types of advanced or metastatic cancer being studied.