Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRegeneron Pharmaceuticals
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
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
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ and bone marrow function, as described in the protocol
Disqualifiers
Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study intervention(s)
Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study intervention(s)
Another malignancy that is progressing or requires active treatment, as described in the protocol
Untreated or active Central Nervous System (CNS) metastases, or carcinomatous meningitis, as described in the protocol
Trial design
Design model
Parallel
Treatments tested in this trial
Ubamatamab
DrugAdministered per the protocol
Bevacizumab
DrugAdministered per the protocol
Cemiplimab
DrugAdministered per the protocol
Fianlimab
DrugAdministered per the protocol
PLD
DrugAdministered per the protocol
Sarilumab
DrugAdministered per the protocol
REGN10597
DrugAdministered per the protocol
Treatment groups
297 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Arm A1Experimental treatment 2 interventions
Group B: Arm A2Experimental treatment 2 interventions
Group C: Arm BExperimental treatment 3 interventions
Group D: Arm CExperimental treatment 4 interventions
Group E: Arm DExperimental treatment 3 interventions
Group F: Arms E1/E2Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment
Time frame
Up to 3 yearsSecondary outcomes
1
Cancer Antigen (CA) -125 response by Gynecologic Cancer Intergroup (GCIG) Criteria
Time frame
Up to 3 years2
Complete Response (CR) rate by RECIST 1.1
Time frame
Up to 3 years3
Disease Control Rate (DCR) by RECIST 1.1
Time frame
Up to 3 years4
Duration of Response (DOR) by RECIST 1.1
Time frame
Up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov