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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian, 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

Exclusion Criteria

  1. Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug(s) 2. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study drug(s) 3. Another malignancy that is progressing or requires active treatment, as described in the protocol 4. Untreated or active primary brain tumor, Central Nervous System (CNS) metastases, or spinal cord compression, 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 NOTE: Other protocol-defined inclusion/exclusion criteria apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A1 		Randomization as described in the protocol
  • Drug: Ubamatamab
    Administered per the protocol
    Other names:
    • REGN4018
  • Drug: Sarilumab
    Prophylaxis administered per the protocol
    Other names:
    • Kevzara®
    • REGN88
    • SAR153191
Experimental
Arm A2 		Randomization as described in the protocol
  • Drug: Ubamatamab
    Administered per the protocol
    Other names:
    • REGN4018
  • Drug: Sarilumab
    Prophylaxis administered per the protocol
    Other names:
    • Kevzara®
    • REGN88
    • SAR153191
Experimental
Arm B 		Randomization as described in the protocol
  • Drug: Ubamatamab
    Administered per the protocol
    Other names:
    • REGN4018
  • Drug: Bevacizumab
    Administered per the protocol
    Other names:
    • Avastin®
  • Drug: Sarilumab
    Prophylaxis administered per the protocol
    Other names:
    • Kevzara®
    • REGN88
    • SAR153191
Experimental
Arm C 		Randomization as described in the protocol
  • Drug: Ubamatamab
    Administered per the protocol
    Other names:
    • REGN4018
  • Drug: Cemiplimab
    Administered per the protocol
    Other names:
    • Libtayo®
    • REGN2810
  • Drug: Fianlimab
    Administered per the protocol
    Other names:
    • REGN3767
  • Drug: Sarilumab
    Prophylaxis administered per the protocol
    Other names:
    • Kevzara®
    • REGN88
    • SAR153191
Experimental
Arm D 		Randomization as described in the protocol
  • Drug: Ubamatamab
    Administered per the protocol
    Other names:
    • REGN4018
  • Drug: PLD
    Administered per the protocol
    Other names:
    • Doxil®
    • Pegylated liposomal doxorubicin
  • Drug: Sarilumab
    Prophylaxis administered per the protocol
    Other names:
    • Kevzara®
    • REGN88
    • SAR153191

Recruiting Locations

The University of Kansas Cancer Center
Westwood 4281639, Kansas 4273857 66205

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.