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

Advanced Solid Tumor Clinical Trial

Official title:

A Phase 1b/2 Open-Label Study of the Efficacy and Safety of Etigilimab (MPH313) Administered in Combination With Nivolumab to Subjects With Locally Advanced or Metastatic Solid Tumors (ACTIVATE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761198
• Other study ID #: MPH313-1-02
• Secondary ID: 2020-004222-37
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 23, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2024
• Source: Mereo BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 subjects with locally advanced or metastatic solid tumors. Subjects will be assigned to receive etigilimab (every 2 weeks) in combination with nivolumab (240 mg every 2 weeks).

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 subjects with locally advanced or metastatic solid tumors. Subjects 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. Subjects may continue to receive treatment beyond documented RECIST 1.1 or disease progression. Subjects who are both CPI (checkpoint inhibitor) naïve as well as subjects 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.
• 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
• Subjects with active, known or suspected autoimmune diseases
• Prior treatment with CD137 agonists, anti-CTLA-4 and anti-TIGIT antibodies
• History of any Grade 3 or 4 immune-related 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 HIV, hepatitis B, hepatitis C
• Medical illness or abnormal laboratory finding that would, in the Study Investigator's judgement, increase the risk to the subject associated with participation in the study
• Pregnancy in female subjects

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Metastatic Solid Tumor
• Neoplasms
• Solid Tumor, Adult

Intervention

Drug:
• Etigilimab dosing
IV infusion of IV etigilimab every 2 weeks
• Nivolumab
IV infusion of nivolumab every 2 weeks

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Mereo BioPharma	ICON Clinical Research

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	The ORR is the proportion of subjects whose best response rate (BOR) is confirmed CR or confirmed PR radiographically according to RECISTv1.1. Where BOR is defined as the best investigator-assessed confirmed response during the time period.	Approximately 24 months.