Clinical Trials /

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

NCT04761198

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).

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Cervical Carcinoma
  • Endometrial Carcinoma
  • Gastric Adenocarcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Etigilimab and Nivolumab in Subjects With Locally Advanced or Metastatic Tumors.
  • 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.

Clinical Trial IDs

  • ORG STUDY ID: MPH313-1-02
  • SECONDARY ID: 2020-004222-37
  • NCT ID: NCT04761198

Conditions

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

Interventions

DrugSynonymsArms
Etigilimab dosingMPH313Cervical cancer on or after chemotherapy
NivolumabOpdivoCervical cancer on or after chemotherapy

Purpose

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).

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
      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) and select rare tumors.
    

Trial Arms

NameTypeDescriptionInterventions
Squamous cell carcinoma of the head and neckExperimentalAdvanced and/or recurrent or metastatic squamous cell carcinoma of the head and neck
  • Etigilimab dosing
  • Nivolumab
Cervical cancer on or after chemotherapyExperimentalRecurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1
  • Etigilimab dosing
  • Nivolumab
Gastric or gastroesophageal junction adenocarcinomaExperimentalRecurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
  • Etigilimab dosing
  • Nivolumab
Endometrial carcinomaExperimentalAdvanced and/or metastatic endometrial carcinoma
  • Etigilimab dosing
  • Nivolumab
Tumor burden high (TMB-H) and microsatellite stable (MSS) solid tumorsExperimentalAdvanced or metastatic tumor mutational burden-high (TMB-H)
  • Etigilimab dosing
  • Nivolumab
Rare disease with high prevalence of TIGIT expressionExperimentalSelect rare tumors
  • Etigilimab dosing
  • Nivolumab

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.

          -  ECOG performance status of 0 to 1

          -  Adequate contraception for women of childbearing potential

          -  6-month 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

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Approximately 24 months.
Safety Issue:
Description: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.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Mereo BioPharma

Trial Keywords

  • etigilimab
  • nivolumab
  • anti-TIGIT antibody
  • MPH313
  • Opdivo

Last Updated

May 10, 2021