Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06787612
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ubamatamab — DRUG
    Administered per the protocol
  • Bevacizumab — DRUG
    Administered per the protocol
  • Cemiplimab — DRUG
    Administered per the protocol
  • Fianlimab — DRUG
    Administered per the protocol
  • PLD — DRUG
    Administered per the protocol
  • Sarilumab — DRUG
    Administered per the protocol

Study Details

This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on patients 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 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

Key Dates

Start date
May 28, 2025
Status verified
May 2026
Primary completion
Oct 30, 2028
Completion
Oct 30, 2028

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A1
  • Experimental: Arm A2
  • Experimental: Arm B
  • Experimental: Arm C
  • Experimental: Arm D

Primary Outcome Measure

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment [ Time Frame: Up to 3 years ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
The University of Alabama at BirminghamBirminghamAlabama35233-
UC San Diego HealthLa JollaCalifornia92037-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
University of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Advent Health Cancer InstituteOrlandoFlorida32804-
Tampa General Hospital Cancer InstituteTampaFlorida33606-
University of ChicagoChicagoIllinois60637-
The University of Kansas Cancer CenterWestwoodKansas66205-
Norton Cancer Institute, St. Matthews ClinicLouisvilleKentucky40207-
Massachusetts General HospitalBostonMassachusetts02114-
Karmanos Cancer InstituteDetroitMichigan48201-
The Ohio State University Comprehensive Cancer CenterHilliardOhio43026-
Providence Cancer InstitutePortlandOregon97213-
University of Pittsburgh Medical Center, Magee-Womens HospitalPittsburghPennsylvania15213-
West Penn Hospital of Allegheny Health NetworkPittsburghPennsylvania15224-
Avera Cancer Institute Sioux FallsSioux FallsSouth Dakota57105-
UT Southwestern Medical CenterDallasTexas75390-
Swedish Cancer InstituteSeattleWashington98104-
University of WisconsinMadisonWisconsin53792-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
The University of Alabama at Birmingham· Birmingham, ALUC San Diego Health· La Jolla, CACedars Sinai Medical Center· Los Angeles, CAMayo Clinic Jacksonville· Jacksonville, FLUniversity of Miami Sylvester Comprehensive Cancer Center· Miami, FLAdvent Health Cancer Institute· Orlando, FL

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