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Study of REGN4659 in Combination With Cemiplimab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

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. Read our disclaimer for details. Identifier: NCT03580694
Recruitment Status : Terminated (Program reprioritization)
First Posted : July 9, 2018
Last Update Posted : March 13, 2020
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
The objective of this trial is to study REGN4659 and cemiplimab in treatment-experienced, non-small cell lung cancer (NSCLC) patients. There are 2 phases of this study: a dose escalation phase and a dose expansion phase.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: REGN4659 Drug: Cemiplimab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of REGN4659 (Anti-CTLA-4 mAb) in Combination With Cemiplimab (Anti-PD-1 mAb) in the Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Actual Study Start Date : June 27, 2018
Actual Primary Completion Date : December 4, 2019
Actual Study Completion Date : December 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Cemiplimab Monotherapy
In a single dose escalation cohort, participants will receive cemiplimab alone.
Drug: Cemiplimab
Cemiplimab will be administered by intravenous (IV) infusion.
Other Name: REGN2810

Experimental: Combination Therapy

Dose Escalation cohorts:

In 3 dose escalation cohorts, participants will receive a lead-in dose of REGN4659 followed by REGN4659 and cemiplimab in combination.

In 4 dose escalation cohorts, participants will receive REGN4659 with cemiplimab in combination.

Dose Expansion cohorts:

In dose expansion cohorts, participants will receive combination regimens of REGN4659 and cemiplimab.

Drug: REGN4659
REGN4659 will be administered by intravenous (IV) infusion.

Drug: Cemiplimab
Cemiplimab will be administered by intravenous (IV) infusion.
Other Name: REGN2810

Primary Outcome Measures :
  1. Rate of dose limiting toxicities (DLTs) during the dose escalation phase [ Time Frame: Up to week 126 ]
  2. Rate of treatment emergent adverse events (TEAEs) [ Time Frame: Up to week 126 ]
  3. Rate of immune-related adverse events (irAEs) [ Time Frame: Up to week 126 ]
  4. Rate of serious adverse events (SAEs) [ Time Frame: Up to week 126 ]
  5. Rate of deaths [ Time Frame: Up to week 126 ]
  6. Laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) [ Time Frame: Up to week 126 ]
  7. Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 during the dose expansion phase [ Time Frame: Up to week 126 ]
  8. REGN4659 and cemiplimab concentrations in serum over time [ Time Frame: Up to week 126 ]

Secondary Outcome Measures :
  1. ORR based on RECIST 1.1 during the dose escalation phase [ Time Frame: Up to week 126 ]
  2. ORR based on immune-based therapy Response Evaluation Criteria (iRECIST) [ Time Frame: Up to week 126 ]
  3. Best overall response (BOR) [ Time Frame: Up to week 126 ]
  4. Duration of response (DOR) [ Time Frame: Up to week 126 ]
  5. Disease control rate [ Time Frame: Up to week 126 ]
  6. Progression-free-survival (PFS) based on RECIST 1.1 [ Time Frame: Up to week 126 ]
  7. PFS based on iRECIST [ Time Frame: Up to week 126 ]
  8. Overall survival (OS) [ Time Frame: Up to week 126 ]

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:   All
Accepts Healthy Volunteers:   No

KEY Inclusion Criteria:

  1. Patients with histologically or cytologically documented squamous or non-squamous NSCLC with unresectable stage IIIB or stage IV disease
  2. Combination dose escalation cohorts: Treatment-experienced patients who have received no more than 3 lines of systemic therapy including no more than 2 lines of cytotoxic chemotherapy, and for whom no available therapy has a high probability to convey clinical benefit.
  3. Dose escalation cohort C: Anti-PD-1/PD-L1 naïve patients who have received 1 to 2 prior lines of cytotoxic chemotherapy including a platinum doublet-containing regimen
  4. Expansion cohort(s): Anti-PD-1/PD-L1 experienced patients who have progressed while receiving therapy or within 6 months of stopping therapy for stage III or IV disease. Patients must not have permanently discontinued anti-PD-1/PD-L1 therapy due to treatment related AE. Patients must have received one line of anti-PD--1/PD-L1 immunotherapy. Patients may also have received one line of chemotherapy

KEY Exclusion Criteria:

  1. Expansion cohort(s) only: Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
  2. Active or untreated brain metastases or spinal cord compression. Patients are eligible if central nervous system (CNS) metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. Patients must be off (immunosuppressive doses of) corticosteroid therapy
  3. Expansion cohort(s) only: Patients with tumors tested positive for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) gene mutations or ROS1 fusions.
  4. Radiation therapy within 2 weeks prior to enrollment and not recovered to baseline from any AE due to radiation
  5. Patients who received prior treatment with an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody
  6. Previous treatment with idelalisib (ZYDELIG®) at any time

Note: Other protocol defined 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 identifier (NCT number): NCT03580694

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United States, Illinois
Regeneron Investigational Site
Chicago, Illinois, United States, 60637
United States, Michigan
Regeneron Investigational Site
Grand Rapids, Michigan, United States, 49546
United States, North Carolina
Regeneron Investigational Site
Charlotte, North Carolina, United States, 28204
United States, Oklahoma
Regeneron Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Regeneron Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Regeneron Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Regeneron Pharmaceuticals
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals Identifier: NCT03580694    
Other Study ID Numbers: R4659-ONC-1795
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Non-Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Immunological
Antineoplastic Agents