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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04761198
Recruitment Status : Active, not recruiting
First Posted : February 18, 2021
Last Update Posted : March 27, 2023
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Mereo BioPharma

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Advanced Solid Tumor Metastatic Solid Tumor Drug: Etigilimab dosing Drug: Nivolumab Phase 1 Phase 2

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), select rare tumors and ovarian carcinoma.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Basket study
Masking: None (Open Label)
Primary Purpose: Basic Science
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)
Actual Study Start Date : March 23, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Squamous cell carcinoma of the head and neck
Advanced and/or recurrent or metastatic squamous cell carcinoma of the head and neck
 Drug: Etigilimab dosing
IV infusion of IV etigilimab every 2 weeks
Other Name: MPH313

Drug: Nivolumab
IV infusion of nivolumab every 2 weeks
Other Name: Opdivo
Experimental: Cervical cancer on or after chemotherapy
Recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1
 Drug: Etigilimab dosing
IV infusion of IV etigilimab every 2 weeks
Other Name: MPH313

Drug: Nivolumab
IV infusion of nivolumab every 2 weeks
Other Name: Opdivo
Experimental: Gastric or gastroesophageal junction adenocarcinoma
Recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
 Drug: Etigilimab dosing
IV infusion of IV etigilimab every 2 weeks
Other Name: MPH313

Drug: Nivolumab
IV infusion of nivolumab every 2 weeks
Other Name: Opdivo
Experimental: Endometrial carcinoma post-platinum <3L treatment
Advanced and/or metastatic endometrial carcinoma
 Drug: Etigilimab dosing
IV infusion of IV etigilimab every 2 weeks
Other Name: MPH313

Drug: Nivolumab
IV infusion of nivolumab every 2 weeks
Other Name: Opdivo
Experimental: Tumor burden high (TMB-H) and microsatellite stable (MSS) solid tumors
Advanced or metastatic tumor mutational burden-high (TMB-H)
 Drug: Etigilimab dosing
IV infusion of IV etigilimab every 2 weeks
Other Name: MPH313

Drug: Nivolumab
IV infusion of nivolumab every 2 weeks
Other Name: Opdivo
Experimental: Rare disease with high prevalence of TIGIT expression
Select rare tumors
 Drug: Etigilimab dosing
IV infusion of IV etigilimab every 2 weeks
Other Name: MPH313

Drug: Nivolumab
IV infusion of nivolumab every 2 weeks
Other Name: Opdivo
Experimental: Ovarian cancer
Recurrent high grade serous and endometrioid ovarian cancer, fallopian tube cancer or primary peritoneal cancer following front-line platinum-based therapy
 Drug: Etigilimab dosing
IV infusion of IV etigilimab every 2 weeks
Other Name: MPH313

Drug: Nivolumab
IV infusion of nivolumab every 2 weeks
Other Name: Opdivo
Experimental: Endometrial carcinoma post standard of care therapy
Advanced and/or metastatic endometrial carcinoma
 Drug: Etigilimab dosing
IV infusion of IV etigilimab every 2 weeks
Other Name: MPH313

Drug: Nivolumab
IV infusion of nivolumab every 2 weeks
Other Name: Opdivo


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Approximately 24 months. ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04761198


Locations
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United States, Arizona
Mereo Investigator Site
Phoenix, Arizona, United States, 85054
United States, California
Mereo Investigator Site
Greenbrae, California, United States, 94904
Mereo Investigator Site
Los Angeles, California, United States, 90025
United States, Florida
Mereo Investigator Site
Jacksonville, Florida, United States, 32224
United States, Massachusetts
Mereo Investigator Site
Boston, Massachusetts, United States, 02215
United States, Michigan
Mereo Investigator Site
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mereo Investigator Site
Rochester, Minnesota, United States, 55905
United States, New York
Mereo Investigator Site
New York, New York, United States, 10065
United States, North Carolina
Mereo Investigator Site
Durham, North Carolina, United States, 27710
United States, Oklahoma
Mereo Investigator Site
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Mereo Investigator Site
Nashville, Tennessee, United States, 37203
United States, Texas
Mereo Investigator Site
Houston, Texas, United States, 77030
United States, Utah
Mereo Investigator Site
West Valley City, Utah, United States, 84119
United States, Virginia
Mereo Investigator Site
Fairfax, Virginia, United States, 22031
United Kingdom
Royal Marsden
London, United Kingdom
Sarah Cannon UK
London, United Kingdom
Sponsors and Collaborators
Mereo BioPharma
ICON Clinical Research
More Information
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Responsible Party: Mereo BioPharma
ClinicalTrials.gov Identifier: NCT04761198    
Other Study ID Numbers: MPH313-1-02
2020-004222-37 ( EudraCT Number )
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: March 27, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mereo BioPharma:
etigilimab
nivolumab
anti-TIGIT antibody
 MPH313
Opdivo
ACTIVATE
Additional relevant MeSH terms:
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Neoplasms
Nivolumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action