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Trial record 1 of 2 for:    regeneron | ovarian cancer | within 50 miles of Boston, Massachusetts, U.S.
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Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03564340
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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Brief Summary:

Primary Objectives

In the Dose Escalation Phase:

• To assess the safety and pharmacokinetics (PK) in order to determine a maximally tolerated dose (MTD) or recommended phase 2 dose (RP2D) of REGN4018 as monotherapy and in combination with cemiplimab.

In the Dose Expansion Phase:

• To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab, (separately by cohort) as determined by the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Secondary Objectives

In the Dose Escalation Phase:

• To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab (separately by cohort) as determined by ORR by RECIST 1.1

In the Dose Expansion Phase:

  • To characterize the safety profile in each expansion cohort
  • To characterize the PK of REGN4018 as monotherapy and in combination with cemiplimab.
  • To assess the effects of REGN4018 as monotherapy and in combination with cemiplimab on patient-reported outcomes (PROs), including health-related quality of life (HRQoL), functioning, and symptoms

In both the Dose Escalation and Dose Expansion Phases:

  • To assess preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab (separately by cohort) as measured by ORR based on iRECIST, best overall response (BOR), duration of response (DOR), disease control rate, complete response (CR) rate and progression-free survival (PFS) based on RECIST 1.1 and iRECIST
  • To assess efficacy of REGN4018 as monotherapy and in combination with cemiplimab as measured by CA-125 level.
  • Immunogenicity of REGN4018 and cemiplimab

Condition or disease Intervention/treatment Phase
Recurrent Ovarian Cancer Recurrent Fallopian Tube Cancer Recurrent Primary Peritoneal Cancer Drug: REGN4018 Drug: cemiplimab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 554 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : July 24, 2024
Estimated Study Completion Date : July 24, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Monotherapy
REGN4018 administration
 Drug: REGN4018
REGN4018 will be administered in a series of dose escalation and dose expansion cohorts by intravenous (IV) infusion and/or subcutaneous (SC) as described in the protocol during 6-week cycle (42 days).
Experimental: Combination Therapy
REGN4018 and cemiplimab administration
 Drug: REGN4018
REGN4018 will be administered in a series of dose escalation and dose expansion cohorts by intravenous (IV) infusion and/or subcutaneous (SC) as described in the protocol during 6-week cycle (42 days).

Drug: cemiplimab
Cemiplimab will be administered by IV infusion once a REGN4018 monotherapy dose has been selected.
Other Names:
  • REGN2810
  • Libtayo


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with Dose-limiting toxicity (DLTs) for REGN4018 monotherapy [ Time Frame: From Cycle 1, Day 1 up to 35 days ]
    Dose Escalation Phase

  2. Number of participants with DLTs for REGN4018 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 (irAEs)) for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation Phase

  4. Number of participants with TEAEs (including irAEs) for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation Phase

  5. Number of participants with serious adverse events (SAEs) for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation Phase

  6. Number of participants with SAEs for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation Phase

  7. Number of deaths for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation Phase

  8. Number of deaths for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation Phase

  9. Number of participants with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation Phase

  10. Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation Phase

  11. Concentration of REGN4018 in serum over time for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation Phase

  12. Concentration of REGN4018 in serum over time for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation Phase

  13. Objective response rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Eisenhauer 2009) for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  14. ORR defined by RECIST 1.1 for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase


Secondary Outcome Measures :
  1. ORR based on RECIST 1.1 (Eisenhauer 2009) for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation Phase

  2. ORR based on RECIST 1.1 for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation Phase

  3. Number of participants with TEAEs (including irAEs) for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  4. Number of participants with TEAEs (including irAEs) for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  5. Number of participants with SAEs for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  6. Number of participants with SAEs for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  7. Number of deaths for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  8. Number of deaths for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  9. Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  10. Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  11. Concentration of REGN4018 in serum over time for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  12. Concentration of REGN4018 in serum over time for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    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 REGN4018 monotherapy [ Time Frame: Baseline up to 62 weeks ]

    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 REGN4018 with cemiplimab [ Time Frame: Baseline up to 62 weeks ]
    Dose Expansion Phase

  15. Change from baseline in physical functioning as measured by the EORTC QLQ-C30 physical functioning score for REGN4018 monotherapy [ Time Frame: Baseline up to 62 weeks ]
    Dose Expansion Phase

  16. Change from baseline in physical functioning as measured by the EORTC QLQ-C30 physical functioning score for REGN4018 with cemiplimab [ Time Frame: Baseline up to 62 weeks ]
    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 REGN4018 monotherapy [ Time Frame: Baseline up to 62 weeks ]

    Dose Expansion Phase

    MOST-T24 (MOST v2) (King et al. 2018) contains 24 of the original 35 items, focusing on symptoms (21 items) and well-being (3 items). 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). For all multi-item indexes, except the MOST-well-being index, compute the average of the component items (range 0-10) and then multiply this score by 10 (0-100 range). Thus, a higher score is equal to higher symptom burden. To calculate the MOST-Well-being index, repeat these same steps (i.e. take the average of the component items and multiply this score by 10) and then subtract this score from 100 so that a higher score is equal to greater well-being.


  18. Change from baseline in abdominal symptoms as measured by the Measure of Ovarian Symptoms and Treatment (MOST)-Abdominal index score for REGN4018 with cemiplimab [ Time Frame: Baseline up to 62 weeks ]
    Dose Expansion Phase

  19. Time to deterioration in GHS/QoL for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  20. Time to deterioration in GHS/QoL for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  21. Time to deterioration in physical functioning for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  22. Time to deterioration in physical functioning for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  23. Time to deterioration in abdominal symptoms for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  24. Time to deterioration in abdominal symptoms for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  25. Change from baseline in QoL as measured by EQ-5D for REGN4018 monotherapy [ Time Frame: Baseline up to 62 weeks ]
    Dose Expansion Phase

  26. Change from baseline in QoL as measured by EQ-5D for REGN4018 with cemiplimab [ Time Frame: Baseline up to 62 weeks ]
    Dose Expansion Phase

  27. ORR based on iRECIST (Seymour 2017) for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  28. ORR based on iRECIST for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  29. Best overall response (BOR) based on RECIST 1.1 for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  30. BOR based on iRECIST for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  31. BOR based on RECIST 1.1 for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  32. BOR based on iRECIST for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  33. Duration of response (DOR) based on RECIST 1.1 for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  34. DOR based on iRECIST for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  35. DOR based on RECIST 1.1 for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  36. DOR based on iRECIST for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  37. Disease control rate based on RECIST 1.1 for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  38. Disease control rate based on iRECIST for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  39. Disease control rate based on RECIST 1.1 for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  40. Disease control rate based on iRECIST for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  41. Complete response (CR) rate based on RECIST 1.1 for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  42. CR rate based on iRECIST 1.1 for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  43. CR rate based on RECIST 1.1 for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  44. CR rate based on iRECIST 1.1 for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  45. Progression-free survival (PFS) based on RECIST 1.1 for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  46. PFS based on iRECIST for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  47. PFS based on RECIST 1.1 for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  48. PFS based on iRECIST for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  49. Cancer antigen-125 (CA-125) response for REGN4018 monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  50. CA-125 response for REGN4018 with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  51. Presence or absence of anti-drug antibodies against REGN4018 [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  52. Presence or absence of anti-drug antibodies against cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. 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:

    1. serum CA-125 level ≥2x upper limit of normal (ULN) (in screening)
    2. 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)
    3. documented relapse or progression on or after the most recent line of therapy
    4. no standard therapy options
  2. Adequate organ and bone marrow function as defined in the protocol
  3. Life expectancy of at least 3 months
  4. Randomized phase 2 expansion cohorts only: Platinum resistant ovarian cancer patients who have had 1 to 4 lines of platinum-based therapy and prior treatment with a poly ADP-ribose polymerase (PARP) inhibitor or bevacizumab as defined in the protocol.

Key Exclusion Criteria:

  1. Recent treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy
  2. Expansion cohort only: More than 4 prior lines of cytotoxic chemotherapy
  3. Prior treatment with a Mucin 16 (MUC16)-targeted therapy
  4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression
  5. History and/or current cardiac findings as defined in the protocol
  6. Severe and/or uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen

Note: Other protocol Inclusion/Exclusion Criteria apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564340


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

Locations
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
More Information
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03564340    
Other Study ID Numbers: R4018-ONC-1721
2019-003298-24 ( EudraCT Number )
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Recurrence
Disease Attributes
Pathologic Processes
 Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Fallopian Tube Diseases
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents