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

Mereo BioPharma76 enrolled

Overview

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).

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 locally advanced or metastatic solid tumors. Participants will be assigned to receive etigilimab (every 2 weeks) in combination with nivolumab (240 mg every 2 weeks) and will continue until either unacceptable toxicity or disease progression. Participants may continue to receive treatment beyond documented Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) or disease progression. Participants who are both checkpoint inhibitor (CPI) naive as well as participants who have received or progressed following a CPI will be eligible and include the following tumor types: head and neck squamous cell carcinoma (HNSCC), cervical carcinoma, gastric or gastroesophageal carcinoma, endometrial carcinoma, tumor mutation burden high (TMB-H), select rare tumors and ovarian carcinoma.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Solid Tumor, Adult Advanced Solid Tumor Metastatic Solid Tumor

Interventions

EtigilimabDRUG

IV infusion of IV etigilimab every 2 weeks

NivolumabDRUG

IV infusion of nivolumab every 2 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

Mereo Investigator Site

Phoenix, Arizona, United States

Mereo Investigator Site

Greenbrae, California, United States

Outcomes

Primary Outcomes

Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1)

The ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1. CR: Disappearance of all target or non-target lesions and normalization of tumor marker level. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Time frame: From first dose of study drug until the date of first objective response (CR or PR) (maximum exposure: 638 days)

Secondary Outcomes

Number of Participants WithTreatment-emergent Adverse Events (TEAEs), Any Adverse Events of Special Interests (AESIs), AESI Immune Related AEs, and AESI Infusion Reactions

TEAEs were defined as adverse events (AEs) with an onset date on or after the date of first administration of study drug up to 100 days after the last dose of study drug and before starting any subsequent cancer treatment. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AESIs were defined as events (serious or non-serious) which were of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor might be appropriate. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.

Time frame: From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days)

Disease Control Rate (DCR) as Assessed Based on RECIST v1.1

The DCR was defined as the percentage of participants who achieved CR, PR, and stable disease (SD). CR: Disappearance of all target or non-target lesions and normalization of tumor marker level. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD: Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits; and no new lesions.

Data from ClinicalTrials.gov

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