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

NCT ID: NCT04761198

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-23
• Study Completion Date: 2023-10-30

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 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).

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 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.

Conditions

Solid Tumor, Adult; Advanced Solid Tumor; Metastatic Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive

Participants with endometrial cancer CPI (programmed death-1 \[PD-1\]/ programmed death ligand-1 \[PD-L1\]) naive will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.

Group Type: EXPERIMENTAL

Etigilimab

Intervention Type: DRUG

IV infusion of IV etigilimab every 2 weeks

Nivolumab

Intervention Type: DRUG

IV infusion of nivolumab every 2 weeks

Cohort B: Head and Neck Squamous Cell Carcinoma

Participants with head and neck cell carcinoma will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.

Group Type: EXPERIMENTAL

Etigilimab

Intervention Type: DRUG

IV infusion of IV etigilimab every 2 weeks

Nivolumab

Intervention Type: DRUG

IV infusion of nivolumab every 2 weeks

Cohort C: Cervical Carcinoma

Participants with cervical carcinoma will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.

Group Type: EXPERIMENTAL

Etigilimab

Intervention Type: DRUG

IV infusion of IV etigilimab every 2 weeks

Nivolumab

Intervention Type: DRUG

IV infusion of nivolumab every 2 weeks

Cohort D (Recurrent Advanced and/or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma)

Participants with recurrent advanced and/or metastatic gastric or gastroesophageal junction adenocarcinoma will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.

Group Type: EXPERIMENTAL

Etigilimab

Intervention Type: DRUG

IV infusion of IV etigilimab every 2 weeks

Nivolumab

Intervention Type: DRUG

IV infusion of nivolumab every 2 weeks

Cohort E: TMB-H + MSS Solid Tumors

Participants with tumour mutational burden-high (TMB-H) and microsatellite stable (MSS) solid tumors will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.

Group Type: EXPERIMENTAL

Etigilimab

Intervention Type: DRUG

IV infusion of IV etigilimab every 2 weeks

Nivolumab

Intervention Type: DRUG

IV infusion of nivolumab every 2 weeks

Cohort F: Rare Tumors (Sarcoma, Uveal Melanoma, Germ Cell)

Participants with rare tumors (sarcoma, uveal melanoma, and germ cell) will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.

Group Type: EXPERIMENTAL

Etigilimab

Intervention Type: DRUG

IV infusion of IV etigilimab every 2 weeks

Nivolumab

Intervention Type: DRUG

IV infusion of nivolumab every 2 weeks

Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated)

Participants with endometrial cancer (PD-1/PD-L1 treated) will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.

Group Type: EXPERIMENTAL

Etigilimab

Intervention Type: DRUG

IV infusion of IV etigilimab every 2 weeks

Nivolumab

Intervention Type: DRUG

IV infusion of nivolumab every 2 weeks

Cohort H: Ovarian Cancer

Participants with ovarian cancer will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.

Group Type: EXPERIMENTAL

Etigilimab

Intervention Type: DRUG

IV infusion of IV etigilimab every 2 weeks

Nivolumab

Intervention Type: DRUG

IV infusion of nivolumab every 2 weeks

Interventions

Etigilimab

IV infusion of IV etigilimab every 2 weeks

Intervention Type: DRUG

Nivolumab

IV infusion of nivolumab every 2 weeks

Intervention Type: DRUG

Other Intervention Names

MPH313; Opdivo

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ICON Clinical Research

INDUSTRY

Sponsor Role: collaborator

Mereo BioPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-004222-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MPH313-1-02

Identifier Type: -

Identifier Source: org_study_id