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

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.
 
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Recruitment Status : Withdrawn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

Tracking Information
First Submitted Date  ICMJE August 5, 2015
First Posted Date  ICMJE August 11, 2015
Last Update Posted Date November 7, 2016
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2015)
  • 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 ]
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02520245 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2015)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Companion Study for Patients Who Completed Participation in a REGN2810 (Anti-PD-1) Clinical Study
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Malignancies
Intervention  ICMJE Drug: REGN2810
Patients will receive REGN2810 by intravenous (IV) infusion
Study Arms  ICMJE Experimental: Open-Label
Intervention: Drug: REGN2810
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 4, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2015)
60
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02520245
Other Study ID Numbers  ICMJE R2810-ONC-1425
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date May 2016

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