Advanced Cancer Clinical Trial
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
Verified date | January 2020 |
Source | Regeneron Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Regeneron Pharmaceuticals | Sanofi |
United States, Australia, Spain,
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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