Loading clinical trials...

Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT02383212•Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Locations (47)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Western Regional Medical Center

Goodyear, Arizona, United States

Mayo Clinic

Phoenix, Arizona, United States

University of Arizona Cancer Center

Tucson, Arizona, United States

City of Hope National Medical Center

Duarte, California, United States

The Angeles Clinic and Research Institute

Los Angeles, California, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Stanford University

Stanford, California, United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Norwalk Hospital

Norwalk, Connecticut, United States

Key Dates

Start Date

February 2, 2015

Primary Completion Date

November 18, 2019

Completion Date

November 18, 2019

Last Updated

January 27, 2020

Enrollment

398

ACTUAL participants

Conditions

Advanced CancerAdvanced Malignancies

Interventions

Cemiplimab

DRUG

Hypofractionated radiotherapy

RADIATION

Cyclophosphamide

DRUG

Docetaxel

DRUG

Carboplatin

DRUG

GM-CSF

DRUG

Paclitaxel

DRUG

Pemetrexed

DRUG

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

View study

RECRUITINGPHASE1

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

NCT04900818

Solid TumorAdvanced Cancer+6 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer

BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)

A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors

A Chaplain-clinician Led Spiritual Care (PEACE) Intervention on Spiritual/Religious Beliefs Related to Medical Care in Patients With Advanced Cancer: a Pilot Clinical Trial