NCT04761198|CompletedPhase 1ResultsDMCFDA Drug

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

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)

Mereo BioPharma ClinicalTrials.gov

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2 other identifiers

MPH313-1-022020-004222-37

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredFeb 2021

StartedMar 2021

CompletionOct 2023

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Mar 2021

Typical duration for phase_1

Geographic Reach

2 countries

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

First Submitted

Initial submission to the registry

February 12, 2021

Completed

6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed

1 month until next milestone

Study Start

First participant enrolled

March 23, 2021

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

March 17, 2025

Completed

Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

2.6 years

First QC Date

February 12, 2021

Results QC Date

January 31, 2025

Last Update Submit

March 7, 2025

Conditions

Solid Tumor, Adult Advanced Solid Tumor Metastatic Solid Tumor

Keywords

etigilimabnivolumabanti-TIGIT antibodyMPH313OpdivoACTIVATE

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

Number of Participants WithTreatment-emergent Adverse Events (TEAEs), Any Adverse Events of Special Interests (AESIs), AESI Immune Related AEs, and AESI Infusion Reactions
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
From first dose of study drug until the date of first BOR (CR, PR, or SD) (maximum exposure: 638 days)
Duration of Response (DoR) as Assessed Based on RECIST v1.1
From first dose of study drug until the date of first overall response of PD or date of death due to underlying cancer (maximum exposure: 638 days)
Duration of Stable Disease (DoSD) as Assessed Based on RECIST v1.1
From first dose of study drug until the date of first overall response of PD or date of death due to underlying cancer (up to a maximum of 680 days)
Serum Concentrations of Etigilimab
Pre-infusion and 15 minutes post-infusion on Cycle 1 Day 1 and Cycle 4 Day 43
+1 more secondary outcomes

Study Arms (8)

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

EXPERIMENTAL

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.