Status:
COMPLETED
A Study of Etigilimab and Nivolumab in Participants With Locally Advanced or Metastatic Tumors
Lead Sponsor:
Mereo BioPharma
Collaborating Sponsors:
ICON Clinical Research
Conditions:
Solid Tumor, Adult
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics of etigilimab in combination with nivolumab in participants with ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2023
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04761198
Start Date
March 23 2021
End Date
October 30 2023
Last Update
March 17 2025
Active Locations (16)
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1
Mereo Investigator Site
Phoenix, Arizona, United States, 85054
2
Mereo Investigator Site
Greenbrae, California, United States, 94904
3
Mereo Investigator Site
Los Angeles, California, United States, 90025
4
Mereo Investigator Site
Jacksonville, Florida, United States, 32224