Study of Nivolumab alone or combined with Ipilimumab for patients with advanced solid tumors (breast, gastric, pancreatic, lung, bladder, or ovarian cancer)

1 1 1 1

What is this study about?

This study focuses on several types of advanced solid tumors, including triple-negative breast cancer, gastric cancer, pancreatic cancer, small cell lung cancer, bladder cancer, and ovarian cancer. The purpose is to investigate how well two medications work together or separately in treating these cancers. The medications being studied are nivolumab and ipilimumab, which are drugs that help the body’s immune system fight cancer cells.

The study will use two different treatment approaches. Some patients will receive nivolumab alone, while others will receive a combination of nivolumab and ipilimumab. Both medications are given through an intravenous infusion, which means they are delivered directly into a vein. The medications being tested are designed to boost the immune system’s ability to detect and destroy cancer cells.

During the study, doctors will monitor how patients respond to the treatment and track any side effects that may occur. The study will look at whether tumors shrink or stop growing in response to the treatment, and how long patients survive without their cancer getting worse. This research may help develop new treatment options for patients with these types of advanced cancers.

1 Initial treatment phase

You will receive treatment through intravenous infusion (medication given directly into a vein)

The treatment will consist of either nivolumab alone or nivolumab combined with ipilimumab

Your doctor will determine which treatment option is appropriate for your specific case

2 Treatment monitoring

Your response to treatment will be regularly evaluated through medical examinations and imaging tests

The doctor will assess if your condition shows complete response (tumor disappearance), partial response (tumor shrinkage), or other changes

Your overall health status will be monitored using a scale called ECOG, which measures your daily activity level

3 Side effect monitoring

Your health will be closely monitored during the first 12 weeks of treatment

Any side effects will be documented and assessed

If necessary, treatment may be adjusted or discontinued based on how your body responds

4 Long-term follow-up

Your progress will be tracked throughout the study period until October 2024

Regular assessments will measure how long the treatment remains effective

Your overall survival and health status will be monitored throughout the study duration

Who Can Join the Study?

You must be an adult (18 years or older)
You must have one of these confirmed types of advanced or spreading (metastatic) cancers:
- Triple Negative Breast Cancer
- Gastric Cancer (stomach cancer)
- Pancreatic Cancer
- Small Cell Lung Cancer
- Bladder Cancer
- Ovarian Cancer
Your cancer must be measurable (doctors must be able to track the size of tumors)
You must have good physical functioning, measured by an ECOG score of 0 or 1 (this means you must be able to perform daily activities with little or no assistance)
Both men and women can participate
Your cancer diagnosis must be confirmed through tissue examination (histologically confirmed)
Your cancer must be either locally advanced (spread in the nearby area) or metastatic (spread to other parts of the body)

Who Cannot Join the Study?

Age under 18 years old
Pregnant or breastfeeding women
Active or untreated brain metastases (cancer that has spread to the brain)
Currently receiving other cancer treatments (chemotherapy, radiation therapy, or immunotherapy)
Severe heart conditions or uncontrolled high blood pressure
Active autoimmune disease (when body’s immune system attacks healthy cells)
History of organ transplant
Active or chronic infections including hepatitis B, hepatitis C, or HIV
Previous severe reactions to similar treatments
Participation in other clinical trials within the last 30 days
Significant liver or kidney problems
History of other cancers within the last 3 years (except for successfully treated skin cancer or early-stage cancer)
Uncontrolled medical conditions that could interfere with the study treatment
Unable to give informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country	Status
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	30.10.2013

Trial locations

Investigated drugs:

Nivolumab is a medication that helps the immune system fight cancer cells. It works by blocking a protein that prevents the immune system from attacking cancer cells, allowing the body’s natural defenses to work better against the tumor. This type of medication is known as an immunotherapy drug.

Ipilimumab is also an immunotherapy medication that helps activate the body’s immune system to fight cancer. It works by targeting a different protein that regulates immune system activity. When combined with Nivolumab, it can enhance the body’s ability to detect and destroy cancer cells.

Both medications are used in this study either alone or in combination to treat various types of advanced cancers, including breast cancer, gastric cancer, pancreatic cancer, lung cancer, bladder cancer, and ovarian cancer.

Investigated diseases:

Triple Negative Breast Cancer – A type of breast cancer where cancer cells lack receptors for estrogen, progesterone, and HER2 protein. It grows and spreads more quickly than other types of breast cancer. The cancer develops in the breast tissue and can spread to nearby lymph nodes and other parts of the body.

Gastric Cancer – A cancer that develops in the lining of the stomach. It begins when cells in the stomach start to grow uncontrollably and form a tumor. The cancer can grow through the stomach’s wall and spread to nearby organs.

Pancreatic Cancer – A disease where malignant cells form in the tissues of the pancreas. The cancer typically starts in the cells that line the ducts of the pancreas. It can spread to nearby blood vessels and organs.

Small Cell Lung Cancer – A fast-growing type of lung cancer that develops in the tissues of the lungs. It typically starts in the bronchi, spreading quickly to other parts of the body. The cancer cells appear small and round under a microscope.

Bladder Cancer – A cancer that begins in the cells lining the bladder. It typically starts in the innermost layer of the bladder wall. The cancer can grow and spread into deeper layers of the bladder wall.

Ovarian Cancer – A cancer that develops in the tissues of the ovaries. It begins when abnormal cells in the ovaries start to multiply uncontrollably. The disease can spread to the lining of the abdomen and to other organs.

Trial ID:

2024-516540-25-00

Protocol code:

CA209-032

NCT ID:

NCT01928394

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of Nivolumab alone or combined with Ipilimumab for patients with advanced solid tumors (breast, gastric, pancreatic, lung, bladder, or ovarian cancer)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?