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Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Patients With Platinum-Resistant Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03564340
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The primary objectives of the Dose Escalation Phase are 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, the primary objectives are 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). The secondary objectives of the Dose Escalation Phase are to assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab (separately by cohort) as determined by ORR.

In the Dose Expansion Phase, the secondary objectives are to characterize the safety profile in each expansion cohort and characterize the PK of REGN4018 as monotherapy and in combination with cemiplimab.

In both the Dose Escalation and Dose Expansion Phases, secondary objectives are 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, and progression-free survival (PFS) and to assess efficacy of REGN4018 as monotherapy and in combination with cemiplimab as measured by CA-125 level.


Condition or disease Intervention/treatment Phase
Advanced Platinum-resistant Ovarian Cancer Advanced Platinum-resistant Fallopian Tube Cancer Advanced Platinum-resistant Primary Peritoneal Cancer Drug: REGN4018 Drug: cemiplimab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Patients With Platinum-Resistant Ovarian Cancer
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : May 5, 2022
Estimated Study Completion Date : May 5, 2022


Arm Intervention/treatment
Experimental: Monotherapy Drug: REGN4018
REGN4018 will be administered in a series of dose escalation cohorts by intravenous (IV) infusion during 6-week cycle (42 days).

Experimental: Combination Therapy Drug: REGN4018
REGN4018 will be administered in a series of dose escalation cohorts by intravenous (IV) infusion during 6-week cycle (42 days).

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




Primary Outcome Measures :
  1. Number of participants with Dose-limiting toxicity (DLTs) [ Time Frame: Up to 28 days ]
    Dose Escalation Phase

  2. Number of participants with Treatment-emergent adverse event (TEAE)s (including immune (iAEs)) [ Time Frame: Up to 62 weeks ]
    Dose Escalation Phase

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

  4. Number of deaths [ Time Frame: Up to 62 weeks ]
    Dose Escalation Phase

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

  6. Concentration in serum at end of infusion (Ceoi) of REGN4018 in monotherapy and in combination with cemiplimab during the dose escalation phase [ Time Frame: Up to 62 weeks ]
  7. Concentration in serum at pre-infusion (Ctrough) of REGN4018 in monotherapy and in combination with cemiplimab during the dose escalation phase. [ Time Frame: Up to 62 weeks ]
  8. Objective response rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Eisenhauer 2009) for monotherapy [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  9. ORR defined by RECIST 1.1 (Eisenhauer 2009) in combination with cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase


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

  2. Number of participants with TEAEs (including immune-related) [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  3. Number of participants with SAEs [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

  4. Number of deaths [ Time Frame: Up to 62 weeks ]
    Dose Expansion Phase

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

  6. Concentration in serum at end of infusion (Ceoi) of REGN4018 in monotherapy and in combination with cemiplimab during the dose expansion phase [ Time Frame: Up to 62 weeks ]
  7. Concentration in serum at pre-infusion (Ctrough) of REGN4018 in monotherapy and in combination with cemiplimab during the dose expansion phase. [ Time Frame: Up to 62 weeks ]
  8. ORR based on Immune-based therapy Response Evaluation Criteria in Solid Tumors (iRECIST) (Seymour 2017) [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  9. Best overall response (BOR) [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  10. Duration of response (DOR) [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

  11. Disease control rate [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

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

  13. PFS based on iRECIST [ Time Frame: Up to 62 weeks ]
    Dose Escalation and Dose Expansion Phases

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



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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. progression or relapse during or within 6 months of the most recent treatment with a platinum-containing chemotherapy regimen
    3. documented progression on the most recent line of therapy
    4. no standard therapy options
  2. Adequate organ and bone marrow function
  3. Adequately controlled blood pressure
  4. Life expectancy of at least 3 months

Key Exclusion Criteria:

  1. Recent treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy
  2. No more than 3 prior lines of cytotoxic chemotherapy for platinum-resistant disease
  3. Prior treatment with idelalisib (excluded from cemiplimab combination cohorts only)
  4. Prior treatment with a Mucin 16 (MUC16)-targeted therapy (excluded from expansion cohorts only)
  5. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression
  6. History of clinically significant cardiac disease

Note: Other protocol Inclusion/Exclusion Criteria apply


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 Trails Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, Massachusetts
Regeneron Study Site Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
Regeneron Study Site Recruiting
Buffalo, New York, United States, 14263
Regeneron Study Site Recruiting
New York, New York, United States, 10032
United States, Ohio
Regeneron Study Site Recruiting
Columbus, Ohio, United States, 43026
United States, Oklahoma
Regeneron Study Site Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Regeneron Study Site Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03564340     History of Changes
Other Study ID Numbers: R4018-ONC-1721
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018

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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
Ovarian Diseases
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases