Health Trials

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

ConditionsRecurrent Ovarian CancerRecurrent Fallopian Tube CancerRecurrent Primary Peritoneal CancerRecurrent Endometrial CancerEndometrial CancerLow-grade Serous Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

The main purpose of this study is to:

* Learn about the safety of ubamatamab and to find out what dose of ubamatamab can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus * The study will also look at the levels of ubamatamab and/or cemiplimab in the body and measure how well the body can remove the study drug(s). This is called pharmacokinetics * The study will also look at any signs that ubamatamab alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus * To find out how safe and tolerable pretreatment is in combination with ubamatamab and to see how well it works to prevent or minimize Cytokine Release Syndrome (CRS)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma)

has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose expansion cohorts)

documented relapse or progression on or after the most recent line of therapy

no standard therapy options likely to convey clinical benefit

Disqualifiers

Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol

Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (does not apply to low-grade serous ovarian cancer cohort)

Prior treatment with a MUC16 - targeted therapy

Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol

Trial design

Design model

Sequential

Treatments tested in this trial

  • Ubamatamab

    Drug

    Administered per the protocol

  • Cemiplimab

    Drug

    Administered per the protocol

  • Sarilumab

    Drug

    Administered per the protocol

  • Tocilizumab

    Drug

    Administered per the protocol

Treatment groups

890 Participants
are divided into 2 treatment groups
Group A: MonotherapyExperimental treatment 3 interventions
Group B: Combination TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Dose Escalation Phase

Time frame
From Cycle 1, Day 1 up to 35 days
2

Number of participants with DLTs for ubamatamab with cemiplimab

Dose Escalation Phase

Time frame
From Cycle 2, Day 1 up to 21 days
3

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

Dose Escalation Phase

Time frame
Up to 2 years
4

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

Dose Escalation Phase

Time frame
Up to 2 years

Secondary outcomes

1

ORR based on RECIST 1.1 for ubamatamab monotherapy

Dose Escalation Phase

Time frame
Up to 2 years
2

ORR based on RECIST 1.1 for ubamatamab with cemiplimab

Dose Escalation Phase

Time frame
Up to 2 years
3

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

Dose Expansion Phase

Time frame
Up to 2 years
4

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

Dose Expansion Phase

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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