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Solid Tumor, AdultPhase 1/2NCT04761198

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

A Phase 1/2 study testing Etigilimab and Nivolumab in people with Solid Tumor, Adult and Advanced Solid Tumor, run by Mereo BioPharma at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Etigilimab and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
16 sitesin 2 countries
Study dates
23 Mar 2021to 30 Oct 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

United States14 sites

  • Mereo Investigator Site

    Ann Arbor, Michigan, 48109

  • Mereo Investigator Site

    Boston, Massachusetts, 02215

  • Mereo Investigator Site

    Durham, North Carolina, 27710

  • Mereo Investigator Site

    Fairfax, Virginia, 22031

  • Mereo Investigator Site

    Greenbrae, California, 94904

  • Mereo Investigator Site

    Houston, Texas, 77030

  • Mereo Investigator Site

    Jacksonville, Florida, 32224

  • Mereo Investigator Site

    Los Angeles, California, 90025

  • Mereo Investigator Site

    Nashville, Tennessee, 37203

  • Mereo Investigator Site

    New York, New York, 10065

  • Mereo Investigator Site

    Oklahoma City, Oklahoma, 73104

  • Mereo Investigator Site

    Phoenix, Arizona, 85054

  • Mereo Investigator Site

    Rochester, Minnesota, 55905

  • Mereo Investigator Site

    West Valley City, Utah, 84119

Other trials in United States

United Kingdom2 sites

  • Royal Marsden

    London

  • Sarah Cannon UK

    London

Other trials in United Kingdom

About this study

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)

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).

Read the 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.

Being tested
Etigilimab, Nivolumab
Keywords
etigilimab, nivolumab, anti-TIGIT antibody, MPH313, Opdivo, ACTIVATE
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtigilimabDrug

    Also called MPH313

    IV infusion of IV etigilimab every 2 weeks

  • NivolumabDrug

    Also called Opdivo

    IV infusion of nivolumab every 2 weeks

Study groups in NCT04761198
Study groupRoleWhat they receive
Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) NaiveExperimentalParticipants 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.
Receives: Drug: Etigilimab; Drug: Nivolumab
Cohort B: Head and Neck Squamous Cell CarcinomaExperimentalParticipants 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.
Receives: Drug: Etigilimab; Drug: Nivolumab
Cohort C: Cervical CarcinomaExperimentalParticipants with cervical carcinoma will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.
Receives: Drug: Etigilimab; Drug: Nivolumab
Cohort D (Recurrent Advanced and/or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma)ExperimentalParticipants 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.
Receives: Drug: Etigilimab; Drug: Nivolumab
Cohort E: TMB-H + MSS Solid TumorsExperimentalParticipants 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.
Receives: Drug: Etigilimab; Drug: Nivolumab
Cohort F: Rare Tumors (Sarcoma, Uveal Melanoma, Germ Cell)ExperimentalParticipants 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.
Receives: Drug: Etigilimab; Drug: Nivolumab
Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated)ExperimentalParticipants 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.
Receives: Drug: Etigilimab; Drug: Nivolumab
Cohort H: Ovarian CancerExperimentalParticipants with ovarian cancer will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.
Receives: Drug: Etigilimab; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  1. Number of Participants WithTreatment-emergent Adverse Events (TEAEs), Any Adverse Events of Special Interests (AESIs), AESI Immune Related AEs, and AESI Infusion Reactions

    TEAEs were defined as adverse events (AEs) with an onset date on or after the date of first administration of study drug up to 100 days after the last dose of study drug and before starting any subsequent cancer treatment. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AESIs were defined as events (serious or non-serious) which were of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor might be appropriate. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.

    Measured: 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)

  2. Disease Control Rate (DCR) as Assessed Based on RECIST v1.1

    The DCR was defined as the percentage of participants who achieved CR, PR, and stable disease (SD). 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 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD: Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits; and no new lesions.

    Measured: From first dose of study drug until the date of first BOR (CR, PR, or SD) (maximum exposure: 638 days)

  3. Duration of Response (DoR) as Assessed Based on RECIST v1.1

    The DoR was defined as the time, in days, from the first of the 2 assessments required for confirmed PR or CR to the time of the progressive disease (PD) or death due to underlying cancer. 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 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of the existing non-target lesions. The appearance of one or more new lesions was also considered progression.

    Measured: 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)

  4. Duration of Stable Disease (DoSD) as Assessed Based on RECIST v1.1

    The DoSD was defined as the time, in days, from the first date of treatment until the first date at which PD was experienced or the participant died due to underlying cancer. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of the existing non-target lesions. The appearance of one or more new lesions was also considered progression.

    Measured: 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)

  5. Serum Concentrations of Etigilimab

    Measured: Pre-infusion and 15 minutes post-infusion on Cycle 1 Day 1 and Cycle 4 Day 43

  6. Number of Participants With Anti-drug Antibodies (ADA) to Etigilimab

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2021
  2. Study start23 Mar 2021
  3. Primary completion30 Oct 2023
  4. Study completion30 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Basket study
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04761198
Sponsor's protocol ID
MPH313-1-02
Other IDs
2020-004222-37
Status last verified
Mar 2025
First submitted
12 Feb 2021
Last updated
17 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Etigilimab and Nivolumab in people with Solid Tumor, Adult and Advanced Solid Tumor, run by Mereo BioPharma at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) (time frame: From first dose of study drug until the date of first objective response (CR or PR) (maximum exposure: 638 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04761198.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.

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