Clinical trial NCT02520245: Companion Study for Patients Who Completed Participation in a REGN2810 (Anti-PD-1) Clinical Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Advanced Malignancies
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Overall survival, from the first dose of study drug administered in the parent REGN2810 clinical study to death or date of last censoring
timeFrame: up to 8 years
measure: 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.
timeFrame: up to 8 years
Secondary outcomes:
measure: Response duration (time from best overall response of partial or complete response, to time to first documented disease progression)
timeFrame: up to 8 years
measure: 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)
timeFrame: up to 8 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Denver
country: United States
facility: Sarah Cannon Research Institute at HealthONE
state: Colorado
city: St. Louis
country: United States
facility: Washington University School of Medicine Siteman Cancer Center
state: Missouri
city: New York
country: United States
facility: Laura & Isaac Perlmutter Cancer Center
state: New York
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: San Antonio
country: United States
facility: START South Texas Accelerated Research Therapeutics
state: Texas
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: