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Completed

NCT Number: NCT04761198

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

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).

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Key information

Conditions

Solid Tumor, Adult Advanced Solid Tumor Metastatic Solid Tumor Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Royal Marsden, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Etigilimab

Drug

IV infusion of IV etigilimab every 2 weeks

Other names: MPH313

Nivolumab

Drug

IV infusion of nivolumab every 2 weeks

Other names: Opdivo

Primary outcomes

  1. 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)

    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.

Secondary outcomes

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

    Time frame: 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)

    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'.

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

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

    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.

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

    Time frame: 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)

    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.

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

    Time frame: 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)

    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.

  5. Serum Concentrations of Etigilimab

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Mereo BioPharma

Industry

Collaborators

  • ICON Clinical Research

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2021
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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