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

NCT02520245 | Withdrawn Phase 1

• 1 other identifier: R2810-ONC-1425
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 9

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.

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (1)

Open-Label

EXPERIMENTAL

Drug: REGN2810

Interventions

REGN2810 DRUG

Patients will receive REGN2810 by intravenous (IV) infusion

Open-Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tolerated prior treatment with REGN2810 with no unacceptable toxicity (except select reversible irAEs) requiring discontinuation of REGN2810
• Developed documented progressive disease after first demonstrating clinical benefit from their initial treatment
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• ≥18 years old
• 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
• Renal function: Serum creatinine ≤ 1.5 x ULN
• 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
• Patients must have completed participation in any REGN2810 clinical study.

You may not qualify if:

• A patient who meets any of the following criteria will be excluded from receiving re-treatment with REGN2810:
• Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs.
• 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.
• Patients who developed ≥ Grade 2 uveitis in a prior REGN2810 protocol
• Immunosuppressive corticosteroid doses (\> 10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
• Active infection requiring therapy, including known infection with human immunodeficiency virus, or active infection with hepatitis B or hepatitis C virus.
• History of pneumonitis within the last 5 years.
• Any investigational or antitumor treatment within 30 days prior to the initial administration of REGN2810.
• History of documented allergic reactions or acute hypersensitivity reaction attributed of Grade ≥ 3 severity during or directly following an REGN2810 infusion
• Known allergy to doxycycline or tetracycline. (precaution due to presence of trace components in REGN2810)
• Breast-feeding
• Positive serum pregnancy test
• 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.
• Acute or chronic psychiatric problems that, under the evaluation of the investigator, make the patient ineligible for participation
• Unwilling to practice adequate contraception during the study until 6 months after the last dose of study drug

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (9)

City of Hope National Medical Center

Duarte, California, United States

Location

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Location

Washington University School of Medicine Siteman Cancer Center

St Louis, Missouri, United States

Location

Laura & Isaac Perlmutter Cancer Center

New York, New York, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Location

Providence Portland Medical Center

Portland, Oregon, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Location

START South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Location

MeSH Terms

Interventions

cemiplimab

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 11, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 7, 2016

Record last verified: 2016-05

Locations

US (9)