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Companion Study for Patients Who Completed Participation in a REGN2810 (Anti-PD-1) Clinical Study

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ClinicalTrials.gov Identifier: NCT02520245
Recruitment Status : Withdrawn
First Posted : August 11, 2015
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
This study has been designed to collect long-term follow-up information for patients who received REGN2810 in other clinical studies and to allow re-treatment for eligible patients.

Condition or disease Intervention/treatment Phase
Advanced Malignancies Drug: REGN2810 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2015
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Arm Intervention/treatment
Experimental: Open-Label Drug: REGN2810
Patients will receive REGN2810 by intravenous (IV) infusion




Primary Outcome Measures :
  1. Overall survival, from the first dose of study drug administered in the parent REGN2810 clinical study to death or date of last censoring [ Time Frame: up to 8 years ]
  2. Safety measured by the number of patients with AEs, AEs leading to discontinuation, SAEs, drug-related AEs, Immune-related adverse events (irAEs), and death as outcome. [ Time Frame: up to 8 years ]
    Safety includes the number of patients with AEs, AEs leading to discontinuation, SAEs, drug-related AEs, Immune-related adverse events (irAEs), and death as outcome.


Secondary Outcome Measures :
  1. Response duration (time from best overall response of partial or complete response, to time to first documented disease progression) [ Time Frame: up to 8 years ]
  2. Duration of disease control (time from best overall response of SD as well as PR and CR to time to first do documented disease progression) [ Time Frame: up to 8 years ]


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
Criteria

The target population for this study is patients who have participated in any REGN2810 clinical study.

Inclusion Criteria for Patients Receiving Re-treatment:

  1. Tolerated prior treatment with REGN2810 with no unacceptable toxicity (except select reversible irAEs) requiring discontinuation of REGN2810
  2. Developed documented progressive disease after first demonstrating clinical benefit from their initial treatment
  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  4. ≥18 years old
  5. Hepatic function:

    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN; if liver metastases ≤ 3 x ULN)
    • Transaminases ≤ 3 x ULN (or ≤ 5.0 x ULN, if liver metastases)
    • Alkaline phosphatase (ALP) ≤ 2.5 x ULN (or ≤ 5.0 x ULN, if liver metastases)
    • For patients with hepatic metastases or hepatic malignancies, exclude patients with concomitant 3 x ULN ≤ aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 5 x ULN and 1.5 x ULN ≤ total bilirubin ≤ 3 x ULN
  6. Renal function: Serum creatinine ≤ 1.5 x ULN
  7. Bone marrow function:

    • Hemoglobin ≥ 9.0 g/dL
    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
    • Platelet count ≥ 75 x 10^9/L

Inclusion Criteria for Patients who Will not Receive Re-treatment:

Patients must have completed participation in any REGN2810 clinical study.

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from receiving re-treatment with REGN2810:

  1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs.
  2. Patients who experienced an irAE in while participating in another REGN2810 protocol who were unable to have their corticosteroid dose reduced to <10 mg per day prednisone equivalent within 12 weeks of toxicity.
  3. Patients who developed ≥ Grade 2 uveitis in a prior REGN2810 protocol
  4. Immunosuppressive corticosteroid doses (> 10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
  5. Active infection requiring therapy, including known infection with human immunodeficiency virus, or active infection with hepatitis B or hepatitis C virus.
  6. History of pneumonitis within the last 5 years.
  7. Any investigational or antitumor treatment within 30 days prior to the initial administration of REGN2810.
  8. History of documented allergic reactions or acute hypersensitivity reaction attributed of Grade ≥ 3 severity during or directly following an REGN2810 infusion
  9. Known allergy to doxycycline or tetracycline. (precaution due to presence of trace components in REGN2810)
  10. Breast-feeding
  11. Positive serum pregnancy test
  12. History within the last 5 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
  13. Acute or chronic psychiatric problems that, under the evaluation of the investigator, make the patient ineligible for participation
  14. Unwilling to practice adequate contraception during the study until 6 months after the last dose of study drug

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): NCT02520245


Locations
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United States, California
City of Hope National Medical Center
Duarte, California, United States
United States, Colorado
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
United States, Missouri
Washington University School of Medicine Siteman Cancer Center
St. Louis, Missouri, United States
United States, New York
Laura & Isaac Perlmutter Cancer Center
New York, New York, United States
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States
United States, Oklahoma
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States
United States, Texas
START South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
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: NCT02520245     History of Changes
Other Study ID Numbers: R2810-ONC-1425
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Neoplasms
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents