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

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Advanced Cancer
• Advanced Malignancies
• Neoplasms

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