Trial record 3 of 45 for:    regeneron | Open Studies

Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Regeneron Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02383212
First received: February 2, 2015
Last updated: March 30, 2015
Last verified: March 2015
  Purpose

This is a phase 1, open-label, multicenter, ascending-dose escalation study of REGN2810, alone and in combination with other anti-cancer therapies in patients with advanced malignancies.


Condition Intervention Phase
Advanced Malignancies
Drug: REGN2810
Radiation: Hypofractionated radiotherapy
Drug: Cyclophosphamide
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A First-in-Human Study of Repeat Dosing With REGN2810, a Monoclonal, Fully Human Antibody to Programmed Death - 1 (PD 1), as Single Therapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Change from baseline to week 48 ] [ Designated as safety issue: Yes ]
    Primary safety variables include incidence and seveirty of TEAEs, abnormal laboratory findings and number of participants with dose limiting toxicities (DLTs)

  • Incidence of abnormal laboratory findings [ Time Frame: Change from baseline to week 48 ] [ Designated as safety issue: Yes ]
  • Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Change from baseline to 28 days after first dose of REGN2810 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response Evaluation Criteria in Solid Tumors (RECIST) as measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) [ Time Frame: Change from baseline to week 48 ] [ Designated as safety issue: No ]
  • Immune-Related Response Criteria (irRC) applied to RECIST measurements [ Time Frame: Change from baseline to week 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2015
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Monotherapy Cohort
REGN2810 will be administered alone
Drug: REGN2810
Experimental: Dual Combination Cohorts

Doses of REGN2810 will be administered in combination with hypofractionated radiotherapy

Doses of REGN2810 will be administered in combination with cyclophosphamide

Drug: REGN2810 Radiation: Hypofractionated radiotherapy Drug: Cyclophosphamide
Experimental: Triple Combination Cohort
Doses of REGN2810 will be administered in combination with hypofractionated radiotherapy plus cyclophosphamide
Drug: REGN2810 Radiation: Hypofractionated radiotherapy Drug: Cyclophosphamide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of malignancy with demonstrated progression of a solid tumor with no alternative standard-of-care therapeutic option available.
  2. At least 1 measurable lesion according to RECIST criteria for response assessment. Patients assigned to radiotherapy require at least 1 additional lesion that can be safely irradiated while sparing the index lesion(s), and for which radiation at the limited, palliative doses contemplated would be considered medically appropriate. The lesion should be causing some signs or symptoms (e.g., tumor-related pain or obstruction-associated decrease in the function of an organ) for which radiation is indicated per the physician's standard clinical practice.
  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
  4. 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 ≤ AST and/or ALT ≤ 5 x ULN AND 1.5 x ULN ≤ total bilirubin ≤ 3 x ULN
  5. Renal function: Serum creatinine ≤1.5 x ULN
  6. 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

Key Exclusion Criteria:

  1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs).
  2. Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway).
  3. Prior treatment with other immune modulating agents within fewer than 4 weeks or 4 half-lives, whichever is greater, prior to the first dose of REGN2810.
  4. Untreated brain metastasis (es) that may be considered active. Patients with previously treated brain metastases may participate provided they are stable (ie, without evidence of progression by imaging for at least 4 weeks prior to the first dose of study treatment, and any neurologic symptoms have returned to baseline), and there is no evidence of new or enlarging brain metastases.
  5. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
  6. Deep vein thrombosis, pulmonary embolism (including asymptomatic pulmonary embolism identified on imaging), or other thromboembolic event within the 6 months preceding the first dose of REGN2810.
  7. Active infection requiring therapy, including known infection with human immunodeficiency virus, or active infection with hepatitis B or hepatitis C virus.
  8. History of pneumonitis within the last 5 years.
  9. Any investigational or antitumor treatment within 30 days prior to the initial administration of REGN2810.
  10. History of documented allergic reactions or acute hypersensitivity reaction attributed to treatment with antibody therapies in general, or to agents specifically used in the study.
  11. Known allergy to doxycycline or tetracycline.
  12. Breast-feeding
  13. Positive serum pregnancy test
  14. 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.
  15. Acute or chronic psychiatric problems that, under the evaluation of the investigator, make the patient ineligible for participation
  16. Continued sexual activity in men or women of childbearing potential who are unwilling to practice adequate contraception during the study

The information provided above is not intended to contain all considerations relevant to potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02383212

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
United States, Missouri
Washington University School of Medicine Siteman Cancer Center Recruiting
St. Louis, Missouri, United States
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States
United States, Texas
START South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02383212     History of Changes
Other Study ID Numbers: R2810-ONC-1423
Study First Received: February 2, 2015
Last Updated: March 30, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Cyclophosphamide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2015