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A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer

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ClinicalTrials.gov Identifier: NCT03430063
Recruitment Status : Active, not recruiting
First Posted : February 12, 2018
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 29, 2018
First Posted Date  ICMJE February 12, 2018
Last Update Posted Date April 8, 2019
Actual Study Start Date  ICMJE May 29, 2018
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
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) in patients whose tumors express PD-L1 in <50% of tumor cells
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
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)
Change History Complete list of historical versions of study NCT03430063 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
  • ORR in all patients [ Time Frame: Up to 31 months ]
  • Overall survival (OS) in patients whose tumors express PD-L1 in <50% of tumor cells [ Time Frame: Up to 31 months ]
  • OS in all patients [ Time Frame: Up to 31 months ]
  • Progression free survival (PFS) in patients whose tumors express PD-L1 in <50% of tumor cells [ Time Frame: Up to 31 months ]
  • PFS in all patients [ Time Frame: Up to 31 months ]
  • Incidences 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 ]
  • Incidences of serious adverse events (SAEs) as assessed by the NCI-CTCAE grading system [ Time Frame: Up to 31 months ]
  • Incidences of deaths [ Time Frame: Up to 31 months ]
  • Incidences of laboratory abnormalities as assessed by the NCI-CTCAE grading system [ Time Frame: Up to 31 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
  • Overall survival (OS) [ Time Frame: Up to 31 months ]
  • Progression free survival (PFS) [ Time Frame: Up to 31 months ]
  • Incidences 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 ]
  • Incidences of serious adverse events (SAEs) as assessed by the NCI-CTCAE grading system [ Time Frame: Up to 31 months ]
  • Incidences of deaths [ Time Frame: Up to 31 months ]
  • Incidences of laboratory abnormalities as assessed by the NCI-CTCAE grading system [ Time Frame: Up to 31 months ]
  • 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 ]
  • Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) [ Time Frame: Up to 31 months ]
  • Assessment of immunogenicity as measured by anti-drug antibody (ADA) titers for REGN2810 [ Time Frame: Up to 31 months ]
  • Assessment of hair pigmentation [ Time Frame: Up to 31 months ]
    As determined by investigator assessment
  • Tumor mutation burden as assessed by the Foundation Medicine "FoundationOne®" panel [ Time Frame: Up to 31 months ]
  • Assessment of tumor volume [ Time Frame: Up to 31 months ]
  • 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 ]
  • Pharmacokinetics(PK): Concentration at end of infusion (Ceoi) [ Time Frame: Up to 31 months ]
  • PK: Preinfusion concentration (Ctrough) [ Time Frame: Up to 31 months ]
  • PK: Time of end of infusion (teoi) [ Time Frame: Up to 31 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer
Official Title  ICMJE 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 Advanced Non-Small Cell Lung Cancer
Brief Summary The primary objective of the study is to compare the objective response rate (ORR) of high dose cemiplimab (HDREGN2810) and standard dose cemiplimab plus ipilimumab combination therapy (SDREGN2810/ipi) to the ORR of standard dose cemiplimab (SDREGN2810) in the second-line treatment of patients with advanced 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Non-Small Cell Lung Carcinoma
Intervention  ICMJE
  • Drug: SDREGN2810
    Standard dose intravenous (IV) infusion
    Other Names:
    • REGN2810
    • cemiplimab
  • Drug: SDREGN2810/ipi
    Combination therapy dose IV
    Other Names:
    • REGN2810
    • cemiplimab
    • ipilimumab
  • Drug: HDREGN2810
    High dose IV
    Other Names:
    • REGN2810
    • cemiplimab
Study Arms  ICMJE
  • Experimental: SDREGN2810
    Intervention: Drug: SDREGN2810
  • Experimental: SDREGN2810/ipi
    Intervention: Drug: SDREGN2810/ipi
  • Experimental: HDREGN2810
    Intervention: Drug: HDREGN2810
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 4, 2019)
28
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2018)
201
Estimated Study Completion Date  ICMJE April 30, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Patients with histologically or cytologically documented squamous or non-squamous NSCLC who either have stage IIIb or stage IIIc disease who are not candidates for treatment with definitive concurrent chemo-radiation or have stage IV disease. Patients must have PD after receiving one prior line of chemotherapy treatment for advanced NSCLC.
  2. Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded tumor tissue biopsy sample
  3. Biopsy evaluable for expression of PD-L1 as 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

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 randomization
  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 apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Korea, Republic of,   Poland,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Australia
 
Administrative Information
NCT Number  ICMJE NCT03430063
Other Study ID Numbers  ICMJE R2810-ONC-1763
2017-003684-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP