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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02383212
Other study ID # R2810-ONC-1423
Secondary ID 2015-002132-41
Status Completed
Phase Phase 1
First received
Last updated
Start date February 2, 2015
Est. completion date November 18, 2019

Study information

Verified date January 2020
Source Regeneron Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 398
Est. completion date November 18, 2019
Est. primary completion date November 18, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of malignancy with demonstrated progression of a solid tumor (non-lymphoma) with no alternative standard-of-care therapeutic option (certain exceptions may apply).

2. At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for response assessment (certain exceptions may apply)

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

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). The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement or psoriasis that does not require systemic treatment.

2. Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway) (certain exceptions may apply)

3. Prior treatment with other immune modulating agents within fewer than 4 weeks prior to the first dose of cemiplimab. Examples of immune modulating agents include blockers of CTLA-4, 4-1BB (CD137), OX-40, therapeutic vaccines, or cytokine treatments.

4. Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may participate provided they are stable (i.e., without evidence of progression by imaging for at least 6 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, and the patient does not require any systemic corticosteroids for management of brain metastases within 4 weeks prior to the first dose of cemiplimab (certain exceptions may apply).

5. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cemiplimab

Radiation:
Hypofractionated radiotherapy

Drug:
Cyclophosphamide

Docetaxel

Carboplatin

GM-CSF

Paclitaxel

Pemetrexed


Locations

Country Name City State
Australia Peter Maccallum Cancer Centre Melbourne
Spain Hospital Universitario Vall d'Hebron Barcelona
Spain Institut Catala d'Oncologia L'hospitalet L'Hospitalet de Llobregat Barcelona
Spain Fundacion Jimenez Diaz Madrid
Spain Hospital Universitario HM Sanchinarro-CIOCC Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain MD Anderson Cancer Center Madrid
United States Winship Cancer Institute, Emory University Atlanta Georgia
United States Dana Farber Cancer Institute Boston Massachusetts
United States University of Chicago Chicago Illinois
United States University Hospitals Case Medical Center Cleveland Ohio
United States Mary Crowley Cancer Research Center - Medical City Dallas Texas
United States Sarah Cannon Research Institute at HealthONE Denver Colorado
United States Barbara Ann Karmanos Cancer Center Detroit Michigan
United States City of Hope National Medical Center Duarte California
United States Duke Cancer Institute Durham North Carolina
United States University of Kansas Cancer Center Fairway Kansas
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States Western Regional Medical Center Goodyear Arizona
United States Hackensack University Medical Center Hackensack New Jersey
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States Baylor College of Medicine Houston Texas
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Indiana University Indianapolis Indiana
United States Ronald Reagan UCLA Medical Center Los Angeles California
United States The Angeles Clinic and Research Institute Los Angeles California
United States Sarah Cannon Research Institute Nashville Tennessee
United States Vanderbilt University Medical Center Nashville Tennessee
United States Cancer Institute of New Jersey New Brunswick New Jersey
United States Columbia University Medical Center New York New York
United States Laura & Isaac Perlmutter Cancer Center New York New York
United States Mount Sinai Medical Center New York New York
United States Weill Cornell Medical College New York New York
United States Norwalk Hospital Norwalk Connecticut
United States Stephenson Cancer Center Oklahoma City Oklahoma
United States Nebraska Methodist Hospital Omaha Nebraska
United States Mayo Clinic Phoenix Arizona
United States University of Pittsburgh Medical Center Shadyside Pittsburgh Pennsylvania
United States Providence Portland Medical Center Portland Oregon
United States Miriam Hospital Providence Rhode Island
United States Washington University School of Medicine Siteman Cancer Center Saint Louis Missouri
United States START South Texas Accelerated Research Therapeutics San Antonio Texas
United States Stanford University Stanford California
United States Northwest Medical Specialties Tacoma Washington
United States H Lee Moffitt Cancer Center and Research Institute Tampa Florida
United States University of Arizona Cancer Center Tucson Arizona
United States Georgetown University Medical Center Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
Regeneron Pharmaceuticals Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment Emergent Adverse Events (TEAEs) Primary safety variables include incidence and severity of TEAEs, abnormal laboratory findings and number of participants with dose limiting toxicities (DLTs) Change from baseline to week 48
Primary Incidence of abnormal laboratory findings Change from baseline to week 48
Primary Number of participants with dose limiting toxicities (DLTs) Change from baseline to 28 days after first dose of cemiplimab
Secondary Response Evaluation Criteria in Solid Tumors (RECIST) as measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Change from baseline to week 48
Secondary Immune-Related Response Criteria (irRC) applied to RECIST measurements Change from baseline to week 48
Secondary Incidence of development of anti-cemiplimab antibodies Up to week 48
Secondary Antitumor activity measured by progression-free survival (PFS) Up to 72 weeks
Secondary Antitumor activity measured by overall survival Up to 249 weeks
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