Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers

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NCT03564340 · readout in 264 d

Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.

Phase

Phase 1/2

Status

Recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

890estimated

Sites

Countries

Australia, Belgium, France +7

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2018-05-21

actual

When the study began enrolling

Primary completion

2027-05-10

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2027-05-10

estimated

The whole study's end, after follow-up

First posted

2018-06-20

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-22

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Recurrent Ovarian Cancer
Recurrent Fallopian Tube Cancer
Recurrent Primary Peritoneal Cancer
Recurrent Endometrial Cancer
Endometrial Cancer
Low-grade Serous Ovarian Cancer

Interventions

Drug: Ubamatamab — also filed as REGN4018
Drug: Cemiplimab — also filed as REGN2810, Libtayo®
Drug: Sarilumab — also filed as Kevzara®, REGN88, SAR153191
Drug: Tocilizumab — also filed as ACTEMRA®, Biosimilar

Primary outcomes

what the primary-completion date above is the date OF

Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy

measured From Cycle 1, Day 1 up to 35 days

Number of participants with DLTs for ubamatamab with cemiplimab

measured From Cycle 2, Day 1 up to 21 days

Number of participants with Treatment-emergent adverse event (TEAE)s (including immune-related adverse events (imAEs)) for ubamatamab monotherapy

measured Up to 2 years

Number of participants with TEAEs (including imAEs) for ubamatamab with cemiplimab

measured Up to 2 years

Number of participants with serious adverse events (SAEs) for ubamatamab monotherapy

measured Up to 2 years

Number of participants with SAEs for ubamatamab with cemiplimab

measured Up to 2 years

Number of deaths for ubamatamab monotherapy

measured Up to 2 years

Number of deaths for ubamatamab with cemiplimab

measured Up to 2 years

Number of participants with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) for ubamatamab monotherapy

measured Up to 2 years

Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab with cemiplimab

measured Up to 2 years

Concentration of ubamatamab in serum over time for ubamatamab monotherapy

measured Up to 2 years

Concentration of ubamatamab in serum over time for ubamatamab with cemiplimab

measured Up to 2 years

Objective response rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for ubamatamab monotherapy

measured Up to 2 years

ORR defined by RECIST 1.1 for ubamatamab with cemiplimab

measured Up to 2 years

Publications

PMID 39652449 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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