No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
297 (estimated)
Sponsor
Regeneron Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for adults with advanced ovarian cancer who have tried other treatments without success. Participants will receive an experimental drug called ubamatamab, alone or with other cancer drugs, to see how well it works and what side effects it may cause.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with advanced serous or endometrioid ovarian cancer.
I have signs that my cancer has progressed after previous therapy.
I have at least one measurable tumor that hasn't been treated with radiation.
My performance status is 0 or 1.
I have adequate organ and bone marrow function.
I have platinum-resistant ovarian cancer.
You may not be able to join if
I have had a major surgery or serious injury in the last 4 weeks.
I have had an allergic reaction to antibody treatments or doxorubicin.
I have another cancer that is getting worse or needs treatment.
I have active brain tumors or meningitis from cancer.
I have uncontrolled infections like HIV or hepatitis.
I have a lot of fluid in my abdomen.
I have had a bowel obstruction in the last 3 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on participants who have advanced ovarian cancer.
The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab, REGN10597 and a standard chemotherapy drug, pegy…
This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on participants who have advanced ovarian cancer.
The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab, REGN10597 and a standard chemotherapy drug, pegylated liposomal doxorubicin \[PLD\]), referred to as "combination drugs'.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug and its experimental combinations
* How much study drug and fianlimab is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) and its combinations
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
1. Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian (regardless of the grade), primary peritoneal, or fallopian tube cancer (clear cell, mucinous, and carcinosarcoma are excluded)
2. Must have progression on pri…
Key Inclusion Criteria:
1. Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian (regardless of the grade), primary peritoneal, or fallopian tube cancer (clear cell, mucinous, and carcinosarcoma are excluded)
2. Must have progression on prior therapy documented radiographically and must have at least 1 measurable lesion (not previously irradiated) that can be accurately measured by RECIST 1.1
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Adequate organ and bone marrow function, as described in the protocol
5. Platinum-Resistant Ovarian Cancer, as described in the protocol
Key Exclusion Criteria:
1. Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study intervention(s)
2. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study intervention(s)
3. Another malignancy that is progressing or requires active treatment, as described in the protocol
4. Untreated or active Central Nervous System (CNS) metastases, or carcinomatous meningitis, as described in the protocol
5. Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency
6. Moderate to large or ascites, as described in the protocol
7. Bowel obstruction within last 3 months or current need for parenteral nutrition
NOTE: Other protocol-defined inclusion/exclusion criteria apply
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