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

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

Conditions

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer

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 (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

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

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
  • Drug: Ubamatamab
    Administered per the protocol
    Other names:
    • REGN4018
  • Drug: Sarilumab
    Administered per the protocol
    Other names:
    • Kevzara®
    • REGN88
    • SAR153191
Experimental
Arm A2
  • Drug: Ubamatamab
    Administered per the protocol
    Other names:
    • REGN4018
  • Drug: Sarilumab
    Administered per the protocol
    Other names:
    • Kevzara®
    • REGN88
    • SAR153191
Experimental
Arm B
  • Drug: Ubamatamab
    Administered per the protocol
    Other names:
    • REGN4018
  • Drug: Bevacizumab
    Administered per the protocol
    Other names:
    • Avastin®
  • Drug: Sarilumab
    Administered per the protocol
    Other names:
    • Kevzara®
    • REGN88
    • SAR153191
Experimental
Arm C
  • 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
    Administered per the protocol
    Other names:
    • Kevzara®
    • REGN88
    • SAR153191
Experimental
Arm D
  • Drug: Ubamatamab
    Administered per the protocol
    Other names:
    • REGN4018
  • Drug: PLD
    Administered per the protocol
    Other names:
    • Doxil®
    • Pegylated liposomal doxorubicin
  • Drug: Sarilumab
    Administered per the protocol
    Other names:
    • Kevzara®
    • REGN88
    • SAR153191

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

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