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

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.

Study Overview

• Status: Withdrawn
• Conditions: Advanced Malignancies
• Intervention / Treatment: Drug: REGN2810

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States
      • City of Hope National Medical Center
  • Colorado
    • Denver, Colorado, United States
      • Sarah Cannon Research Institute at HealthONE
  • Missouri
    • St. Louis, Missouri, United States
      • Washington University School of Medicine Siteman Cancer Center
  • New York
    • New York, New York, United States
      • Laura & Isaac Perlmutter Cancer Center
  • Ohio
    • Cleveland, Ohio, United States
      • University Hospitals Case Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Stephenson Cancer Center
  • Oregon
    • Portland, Oregon, United States
      • Providence Portland Medical Center
  • Tennessee
    • Nashville, Tennessee, United States
      • Sarah Cannon Research Institute
  • Texas
    • San Antonio, Texas, United States
      • Start South Texas Accelerated Research Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open-Label	Drug: REGN2810; Patients will receive REGN2810 by intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival, from the first dose of study drug administered in the parent REGN2810 clinical study to death or date of last censoring		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.	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.	up to 8 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Response duration (time from best overall response of partial or complete response, to time to first documented disease progression)	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)	up to 8 years

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: August 10, 2015
• First Posted (Estimate): August 11, 2015

Study Record Updates

• Last Update Posted (Estimate): November 6, 2016
• Last Update Submitted That Met QC Criteria: November 4, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cemiplimab
• Other Study ID Numbers: R2810-ONC-1425