Regeneron Pharmaceuticals, Inc.R4018-ONC-2445,Ph2,Open label,rand,Ovarian CA, Ubamatamab +/- SOC Ob

What is the Purpose of this Study?

Primary - Efficacy To assess the Objective Response Rate (ORR) of ubamatamab alone or in combination with bevacizumab, cemiplimab + fianlimab, or PLD (separately by study arm). Secondary: Efficacy: To assess preliminary efficacy of Ubamatamab combinations as measured by changes to CA-125 response, CR rate, disease control rate (DCR), duration of response (DOR), and progression-free survival (PFS).


Eligibility

  • 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
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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Abrahm Levi

More about this Clinical Trial

What is the full name of this clinical trial?

R4018-ONC-2445: Multi-Arm Phase 2 study of Ubamatamab with or without additional agents in Platinum - Resistant Ovarian Cancer

Study Details
Disease Type/Condition

Ovary

Principal Investigator

Hafez, Navid

Co-Investigators

Andrew Li, Margaret Liang

Age Group

Adult

Phase

II

IRB Number

STUDY00003993

ClinicalTrials.gov ID

NCT06787612

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Abrahm Levi

Email
Abrahm.Levi@cshs.org
Study Detail
Disease Type/Condition

Ovary

Principal Investigator

Hafez, Navid

Age Group

Adult

Phase

II

IRB Number

R4018-ONC-2445

ClinicalTrials.gov ID

NCT06787612

Key Eligibility
ClinicalTrials.gov

Contact
Name

Abrahm Levi

Email
Abrahm.Levi@cshs.org