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

Advanced Malignancies Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02520245
• Other study ID #: R2810-ONC-1425
• Status: Withdrawn
• Phase: Phase 1
• First received: August 5, 2015
• Last updated: November 4, 2016
• Start date: August 2015
• Est. completion date: November 2023

Study information

• Verified date: May 2016
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Malignancies

Intervention

Drug:
• REGN2810
Patients will receive REGN2810 by intravenous (IV) infusion

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	Response duration (time from best overall response of partial or complete response, to time to first documented disease progression)		up to 8 years	No
Secondary	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	No