RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers

This research study is looking at a new medicine called ubamatamab, either by itself or combined with another medicine called cemiplimab. It's for adults with ovarian cancer or endometrial cancer that has come back. The main goals are to understand how safe ubamatamab is, find the best dose, and see how the body handles the medicine. Researchers also want to find out if these treatments can help shrink or control the cancer. They will also explore ways to prevent or lessen side effects like Cytokine Release Syndrome (CRS). This study focuses on recurrent ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and endometrial cancer.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Regeneron Pharmaceuticals

Enrolment target

890

Start

21 May 2018

Estimated completion

10 May 2027

Recurrent Ovarian Cancer Recurrent Fallopian Tube Cancer Recurrent Primary Peritoneal Cancer Recurrent Endometrial Cancer Endometrial Cancer Low-grade Serous Ovarian Cancer

What is this study about?

This study is testing new treatments for certain types of cancer that have come back. The main treatment being looked at is a drug called ubamatamab. Researchers want to see if giving ubamatamab alone, or with another drug called cemiplimab, can be a safe and effective way to treat advanced ovarian cancer or endometrial cancer. These are cancers that have returned after previous treatments.

The study has a few key aims. First, it will carefully check for any side effects of the drugs and work out the safest dose to give. They will also look at how the drugs move through and are cleared from the body. This helps doctors understand how the medicines work. Most importantly, they want to see if the treatments can help reduce the cancer or stop it from growing. They are also trying to find ways to make the treatment more comfortable by preventing or reducing a specific side effect called Cytokine Release Syndrome (CRS).

If you have been diagnosed with recurrent ovarian cancer, fallopian tube cancer, primary peritoneal cancer, or endometrial cancer, and your doctor thinks you might be suitable, this study could be an option. It's important to remember that this is a research study, and new treatments are still being investigated.

Key takeaways

This study is testing a new drug (ubamatamab) for recurrent ovarian or endometrial cancer.
It aims to find safe doses and see if the treatment helps control the cancer.
Participation involves regular hospital visits for medication, tests, and monitoring.
There might be potential benefits, but also risks and side effects, as with any new treatment.
Other medicines might be given as part of the study to help manage side effects.
You can stop participating in the study at any time.

Who may be eligible?

This study is for adult women, aged 18 or over. For ovarian cancer patients, this includes those with ovarian, fallopian tube, or primary peritoneal cancer that has come back. You would need to have had at least one previous treatment containing platinum chemotherapy, or be unable to have platinum chemotherapy. Your cancer would also need to have progressed after your most recent treatment, and other standard treatment options would have been tried or aren't suitable.

For endometrial cancer patients, this study is for those whose cancer has returned or progressed after treatment with certain types of immunotherapy (anti-PD-1 therapy) and platinum-based chemotherapy. Your cancer cells must show a certain level of MUC16 protein, and you would have had between 1 and 4 previous systemic treatments. All participants must be generally well, with good organ function, and be expected to live for at least 3 months.

There are also reasons why someone might not be able to join. For example, if you have had certain targeted treatments before for MUC16 protein, or specific immunotherapy (anti-PD-1/PD-L1). Also, if you have untreated brain tumours, severe heart conditions, or uncontrolled high blood pressure, you might not be able to take part. The study also has limits on how many previous chemotherapy treatments ovarian cancer patients can have had.

Quick self-check

Are you 18 years old or older?
Do you have recurrent ovarian, fallopian tube, primary peritoneal, or endometrial cancer?
Have you had previous chemotherapy for your cancer?
Are you generally well and able to follow study visits and procedures?
Have you discussed this study with your doctor to see if you might be suitable?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would have medical check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. You would receive the study medication, ubamatamab and/or cemiplimab, as directed by the study doctors. They might also give you other medicines like sarilumab or tocilizumab to help manage potential side effects. The exact number of visits, tests, and the total duration of your participation would depend on which part of the study you are in and how you respond to the treatment. You will have follow-up appointments even after active treatment ends. You are free to withdraw from the study at any time.

Potential risks and benefits

Participating in a clinical trial means you might have access to a new treatment before it is widely available. This new treatment might help control your cancer, possibly shrinking it or slowing its growth, but there is no guarantee it will work for everyone. However, new treatments can also have side effects that are not yet fully known. You might experience common side effects, or possibly more serious ones, which the study team will monitor closely. You also have the right to leave the study at any time, for any reason, without it affecting your future medical care.

Locations (52)

University of Alabama_6th Ave
Birmingham, United States· Recruiting
Massachusetts General Hospital
Boston, United States· Recruiting
Dana Farber / Harvard Cancer Center
Boston, United States· Recruiting
Mayo Clinic - Rochester
Rochester, United States· Recruiting
Roswell Park Cancer Institute
Buffalo, United States· Withdrawn
Columbia University Medical Center
New York, United States· Recruiting
Memorial Sloan Kettering Cancer Center
New York, United States· Recruiting
The Ohio State University Wexner Medical Center James Comprehensive Cancer Center
Hilliard, United States· Recruiting
Stephenson Cancer Center
Oklahoma City, United States· Recruiting
Sarah Cannon Research Institute
Nashville, United States· Recruiting
Virginia Commonwealth University
Richmond, United States· Recruiting
Prince of Wales Hospital
Randwick, Australia· Completed

+40 more sites — see the official record for the full list.

Common questions

What is ubamatamab?

Ubamatamab is a new investigational drug being tested in this study to see if it can help treat certain types of recurrent cancer.

What is cemiplimab?

Cemiplimab is another medicine that is sometimes given alongside ubamatamab in this study. It is a type of immunotherapy.

What is 'recurrent' cancer?

Recurrent cancer means that the cancer has come back after it was previously treated and had either improved or gone away.

What is Cytokine Release Syndrome (CRS)?

CRS is a possible side effect of some cancer treatments, where the body's immune system reacts strongly, causing symptoms like fever or flu-like feelings. The study will try to prevent or reduce this.

Will I have to pay to be in this study?

No, all study-related treatments and tests are provided at no cost if you qualify and choose to participate.

How to find out more

Clinical Trials Administrator

clinicaltrials@regeneron.com 844-734-6643 Official trial record

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