Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03564340

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

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)

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Recurrent Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Low-grade Serous Ovarian Cancer Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Recurrent Endometrial Cancer Recurrent Fallopian Tube Cancer Recurrent Primary Peritoneal Cancer Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Prince of Wales Hospital, Randwick, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Ovarian Cancer Cohorts Only: Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following:
  • 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
  • Adequate organ and bone marrow function as defined in the protocol
  • Life expectancy of at least 3 months
  • Randomized phase 2 expansion cohort (Ovarian Cancer only): Platinum-resistant ovarian cancer patients who have had 2 to 4 lines of platinum-based therapy as defined in the protocol.
  • Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy:
  • MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC), as defined in the protocol
  • 1-4 prior lines of systemic therapy, as described in the protocol

Key Exclusion Criteria:

  • 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
  • History and/or current cardiovascular disease, as defined in the protocol
  • Severe and/or uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen

Note: Other protocol-defined Inclusion/Exclusion Criteria apply

Treatment and study plan

Ubamatamab

Drug

Administered per the protocol

Other names: REGN4018

cemiplimab

Drug

Administered per the protocol

Other names: REGN2810, Libtayo®

Sarilumab

Drug

Administered per the protocol

Other names: Kevzara®, REGN88, SAR153191

Tocilizumab

Drug

Administered per the protocol

Other names: ACTEMRA®, Biosimilar

Primary outcomes

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

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

    Dose Escalation Phase

  2. Number of participants with DLTs for ubamatamab with cemiplimab

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

    Dose Escalation Phase

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

    Time frame: Up to 2 years

    Dose Escalation Phase

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

    Time frame: Up to 2 years

    Dose Escalation Phase

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

    Time frame: Up to 2 years

    Dose Escalation Phase

  6. Number of participants with SAEs for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Escalation Phase

  7. Number of deaths for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Escalation Phase

  8. Number of deaths for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Escalation Phase

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

    Time frame: Up to 2 years

    Dose Escalation Phase

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

    Time frame: Up to 2 years

    Dose Escalation Phase

  11. Concentration of ubamatamab in serum over time for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Escalation Phase

  12. Concentration of ubamatamab in serum over time for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Escalation Phase

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

    Time frame: Up to 2 years

    Dose Expansion Phase

  14. ORR defined by RECIST 1.1 for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Expansion Phase

Secondary outcomes

  1. ORR based on RECIST 1.1 for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Escalation Phase

  2. ORR based on RECIST 1.1 for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Escalation Phase

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

    Time frame: Up to 2 years

    Dose Expansion Phase

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

    Time frame: Up to 2 years

    Dose Expansion Phase

  5. Number of participants with SAEs for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Expansion Phase

  6. Number of participants with SAEs for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Expansion Phase

  7. Number of deaths for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Expansion Phase

  8. Number of deaths for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Expansion Phase

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

    Time frame: Up to 2 years

    Dose Expansion Phase

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

    Time frame: Up to 2 years

    Dose Expansion Phase

  11. Concentration of ubamatamab in serum over time for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Expansion Phase

  12. Concentration of ubamatamab in serum over time for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Expansion Phase

  13. Change from baseline in quality of life (QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 GHS/QoL score for ubamatamab monotherapy

    Time frame: Baseline up to 2 years

    Dose Expansion Phase

    The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social) , symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."

  14. Change from baseline in quality of life (QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 GHS/QoL score for ubamatamab with cemiplimab

    Time frame: Baseline up to 2 years

    Dose Expansion Phase

  15. Change from baseline in physical functioning as measured by the EORTC QLQ-C30 physical functioning score for ubamatamab monotherapy

    Time frame: Baseline up to 2 years

    Dose Expansion Phase

  16. Change from baseline in physical functioning as measured by the EORTC QLQ-C30 physical functioning score for ubamatamab with cemiplimab

    Time frame: Baseline up to 2 years

    Dose Expansion Phase

  17. Change from baseline in abdominal symptoms as measured by the Measure of Ovarian Symptoms and Treatment (MOST)-Abdominal index score for ubamatamab monotherapy

    Time frame: Baseline up to 2 years

    Dose Expansion Phase excluding the Endometrial Cancer Cohort

    The MOST-24 is a 24-item questionnaire used to measure the impact of chemotherapy on symptoms (21 items) and well-being (3 items). The expected questionnaire completion time is less than 5 minutes.

    The prevalence of each MOST item at assessment time points can be summarized by providing the mean, standard deviation and proportions based on the MOST response format, a numeric rating scale with integers from zero to 10, with five verbal anchors: 'No trouble at all' (0), 'Mild' (1-3), 'Moderate' (4-6), 'Severe' (7-10), and 'Worst I can imagine' (10).

  18. Change from baseline in abdominal symptoms as measured by the MOST-Abdominal index score for ubamatamab with cemiplimab

    Time frame: Baseline up to 2 years

    Dose Expansion Phase Not applicable to Endometrial Cancer Cohort

  19. Time to deterioration in GHS/QoL for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Expansion Phase

  20. Time to deterioration in GHS/QoL for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Expansion Phase

  21. Time to deterioration in physical functioning for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Expansion Phase

  22. Time to deterioration in physical functioning for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Expansion Phase

  23. Time to deterioration in abdominal symptoms for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Expansion Phase

  24. Time to deterioration in abdominal symptoms for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Expansion Phase

  25. Change from baseline in QoL as measured by EQ-5D for ubamatamab monotherapy

    Time frame: Baseline up to 2 years

    Dose Expansion Phase

  26. Change from baseline in QoL as measured by EQ-5D for ubamatamab with cemiplimab

    Time frame: Baseline up to 2 years

    Dose Expansion Phase

  27. ORR based on iRECIST for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  28. ORR based on iRECIST for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  29. Best overall response (BOR) based on RECIST 1.1 for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  30. BOR based on iRECIST for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  31. BOR based on RECIST 1.1 for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  32. BOR based on iRECIST for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  33. Duration of response (DOR) based on RECIST 1.1 for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  34. DOR based on iRECIST for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  35. DOR based on RECIST 1.1 for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  36. DOR based on iRECIST for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  37. Disease control rate based on RECIST 1.1 for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  38. Disease control rate based on iRECIST for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  39. Disease control rate based on RECIST 1.1 for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  40. Disease control rate based on iRECIST for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  41. Complete response (CR) rate based on RECIST 1.1 for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  42. CR rate based on iRECIST 1.1 for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  43. CR rate based on RECIST 1.1 for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  44. CR rate based on iRECIST 1.1 for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  45. Progression-free survival (PFS) based on RECIST 1.1 for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  46. PFS based on iRECIST for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  47. PFS based on RECIST 1.1 for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  48. PFS based on iRECIST for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  49. Cancer antigen-125 (CA-125) response for ubamatamab monotherapy

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  50. CA-125 response for ubamatamab with cemiplimab

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  51. Presence or absence of anti-drug antibodies against ubamatamab

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

  52. Presence or absence of anti-drug antibodies against cemiplimab

    Time frame: Up to 2 years

    Dose Escalation and Dose Expansion Phases

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1/2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Jun 20, 2018
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.