A Study of Etigilimab and Nivolumab in Participants With Locally Advanced or Metastatic Tumors

Completed · Phase 1/Phase 2

Conditions studied: Solid Tumor, Adult, Advanced Solid Tumor, Metastatic Solid Tumor

In brief

This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of etigilimab in combination with nivolumab in participants with locally advanced or metastatic solid tumors. Participants will be assigned to receive etigilimab (every 2 weeks) in combination with nivolumab (240 milligrams \[mg\] every 2 weeks).

Key facts

Study ID

NCT04761198

Run by

Mereo BioPharma

People needed

76

Starts

2021-03-23

Expected to finish

2023-10-30

Last updated by the study team

2025-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological or cytological diagnosis of a relevant tumor type as per the study protocol and not candidates for curative surgery or radiation therapy
• Available tumor tissue (archival or newly obtained core or excisional biopsy)
• Adequate hematologic and end organ function as measured by laboratory screening panel in the 14 days prior to treatment
• Life expectancy greater than 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Adequate contraception for women of childbearing potential
• Pre-specified wash-out of prior anti-PD1/PDL-1 therapy

You may not qualify if…

• Concurrent active malignancy
• Major surgery within 4 weeks of treatment
• Participants with active, known or suspected autoimmune diseases
• Prior treatment with cluster of differentiation (CD) 137 agonists, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and anti-T-cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT) antibodies
• History of any Grade 3 or 4 immune-related adverse event (AE) toxicity from prior immunotherapy that resulted in treatment discontinuation
• History of immune-related adverse events that lead to discontinuation of anti-PD-1 or PDL-1 therapy
• Active infections of human immunodeficiency virus (HIV), hepatitis B, hepatitis C
• Medical illness or abnormal laboratory finding that would, in the Study Investigator's judgement, increase the risk to the participant associated with participation in the study
• Pregnancy in female participants

Where it is running

• Mereo Investigator Site — Phoenix, Arizona, United States
• Mereo Investigator Site — Greenbrae, California, United States
• Mereo Investigator Site — Los Angeles, California, United States
• Mereo Investigator Site — Jacksonville, Florida, United States
• Mereo Investigator Site — Boston, Massachusetts, United States
• Mereo Investigator Site — Ann Arbor, Michigan, United States
• Mereo Investigator Site — Rochester, Minnesota, United States
• Mereo Investigator Site — New York, New York, United States
• Mereo Investigator Site — Durham, North Carolina, United States
• Mereo Investigator Site — Oklahoma City, Oklahoma, United States
• Mereo Investigator Site — Nashville, Tennessee, United States
• Mereo Investigator Site — Houston, Texas, United States
• Mereo Investigator Site — West Valley City, Utah, United States
• Mereo Investigator Site — Fairfax, Virginia, United States
• Royal Marsden — London, United Kingdom
• Sarah Cannon UK — London, United Kingdom

Full record on ClinicalTrials.gov

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