Phase 2
Completed N=76
A Study of Etigilimab and Nivolumab in Participants With Locally Advanced or Metastatic Tumors
Solid Tumor, Adult · Advanced Solid Tumor · Metastatic Solid Tumor
Source: ClinicalTrials.gov NCT04761198 ↗
Enrolled (actual)
76
Serious AEs
29.0%
Results posted
Mar 2025
Primary outcomePrimary: Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) — 20.0; 0; 37.5; 0 percentage of participants
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 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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) |
20.0; 0; 37.5; 0; 25.0; 10.0 | — |
| SECONDARY Number of Participants WithTreatment-emergent Adverse Events (TEAEs), Any Adverse Events of Special Interests (AESIs), AESI Immune Related AEs, and AESI Infusion Reactions |
11; 1; 8; 8; 33; 4 | — |
| SECONDARY Disease Control Rate (DCR) as Assessed Based on RECIST v1.1 |
50.0; 0; 62.5; 33.3; 50.0; 50.0 | — |
| SECONDARY Duration of Response (DoR) as Assessed Based on RECIST v1.1 |
197.0; 183.0; 307.0; 464.0; 145.0; 442.0 | — |
| SECONDARY Duration of Stable Disease (DoSD) as Assessed Based on RECIST v1.1 |
81.5; 45.0; 120.0; 57.0; 109.5; 108.0 | — |
| SECONDARY Serum Concentrations of Etigilimab |
NA; 262; 20.1; 273 | — |
| SECONDARY Number of Participants With Anti-drug Antibodies (ADA) to Etigilimab |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04761198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.