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Trial record 3 of 67 for:    regeneron | Recruiting, Not yet recruiting, Available Studies

A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer

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ClinicalTrials.gov Identifier: NCT03430063
Recruitment Status : Not yet recruiting
First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
The primary objective of the study is to compare the objective response rate(ORR) of high dose REGN2810 (HDREGN2810) and standard dose REGN2810 plus ipilimumab combination therapy (SDREGN2810/ipi) versus standard dose REGN2810 (SDREGN2810) in the second-line treatment of patients with advanced or metastatic squamous or non-squamous non-small cell lung cancer (NSCLC), in patients whose tumors express programmed cell death ligand 1 (PD-L1) in <50% of tumor cells.

Condition or disease Intervention/treatment Phase
Metastatic Non-Small Cell Lung Carcinoma Drug: SDREGN2810 Drug: SDREGN2810/ipi Drug: HDREGN2810 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Study of Combinations of Standard and High Dose REGN2810 (Cemiplimab; Anti-PD-1 Antibody) and Ipilimumab (Anti-CTLA-4 Antibody) in the Second-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 <50%
Anticipated Study Start Date : February 28, 2018
Estimated Primary Completion Date : November 9, 2021
Estimated Study Completion Date : November 9, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Ipilimumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: SDREGN2810 Drug: SDREGN2810
Standard dose intravenous (IV) infusion
Other Names:
  • REGN2810
  • cemiplimab
Experimental: SDREGN2810/ipi Drug: SDREGN2810/ipi
Combination therapy dose IV
Other Names:
  • REGN2810
  • cemiplimab
  • ipilimumab
Experimental: HDREGN2810 Drug: HDREGN2810
High dose IV
Other Names:
  • REGN2810
  • cemiplimab



Primary Outcome Measures :
  1. ORR [ Time Frame: Up to 31 months ]
    Proportion of patients achieving complete response (CR) or partial response (PR) as assessed by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to 31 months ]
  2. Progression free survival (PFS) [ Time Frame: Up to 31 months ]
  3. Incidence of treatment emergent adverse events (TEAEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading system [ Time Frame: Up to 31 months ]
  4. Incidence of serious adverse events (SAEs) as assessed by the NCI-CTCAE grading system [ Time Frame: Up to 31 months ]
  5. Incidence of deaths [ Time Frame: Up to 31 months ]
  6. Incidence of laboratory abnormalities as assessed by the NCI-CTCAE grading system [ Time Frame: Up to 31 months ]
  7. Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: Up to 31 months ]
  8. Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) [ Time Frame: Up to 31 months ]
  9. Assessment of immunogenicity as measured by anti-drug antibody (ADA) titers for REGN2810 [ Time Frame: Up to 31 months ]
  10. Assessment of hair pigmentation [ Time Frame: Up to 31 months ]
    As determined by investigator assessment

  11. Tumor mutation burden as assessed by the Foundation Medicine "FoundationOne®" panel [ Time Frame: Up to 31 months ]
  12. Assessment of tumor volume [ Time Frame: Up to 31 months ]
  13. Inducible co-stimulatory positive (ICOS+) cluster of differentiation 4 (CD4) T-cell frequency and other markers of T-cell activation [ Time Frame: Up to 31 months ]
  14. Pharmacokinetics(PK): Concentration at end of infusion (Ceoi) [ Time Frame: Up to 31 months ]
  15. PK: Preinfusion concentration (Ctrough) [ Time Frame: Up to 31 months ]
  16. PK: Time of end of infusion (teoi) [ Time Frame: Up to 31 months ]


Information from the National Library of Medicine

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

Key Inclusion Criteria:

  1. Patients with histologically or cytologically documented squamous or non-squamous NSCLC who either have stage 3b disease and are not candidates for definitive concurrent chemo-radiation or have stage 4 disease. Patients must be immunotherapy naive and must have received one prior cytotoxic regimen.
  2. Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded tumor tissue biopsy sample
  3. Expression of PD-L1 in <50% of tumor cells determined by a PD-L1 Immunohistochemistry (IHC) pharma diagnostic test (pharmDx) assay performed by a central laboratory
  4. At least 1 radiographically measureable lesion by computed tomography (CT) per RECIST 1.1 criteria
  5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
  6. Anticipated life expectancy of at least 3 months

Key Exclusion Criteria:

  1. Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
  2. Active or untreated brain metastases or spinal cord compression
  3. Patients with tumors tested positive for epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene receptor tyrosine kinase (ROS1) fusions
  4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
  5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years
  6. Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest a risk of immunerelated treatment-emergent adverse events (irTEAEs)
  7. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization

Note: Other protocol defined Inclusion/Exclusion criteria may 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): NCT03430063


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

Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03430063     History of Changes
Other Study ID Numbers: R2810-ONC-1763
2017-003684-35 ( EudraCT Number )
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Regeneron Pharmaceuticals:
Advanced non-squamous NSCLC
Advanced squamous NSCLC
Metastatic non-squamous NSCLC
Metastatic squamous NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms