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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Mereo BioPharma
Study ID
NCT04761198
Phase
PHASE1/PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Etigilimab — DRUG
    IV infusion of IV etigilimab every 2 weeks
  • Nivolumab — DRUG
    IV infusion of nivolumab every 2 weeks

Study Details

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).

Key Dates

Start date
Mar 23, 2021
Status verified
Mar 2025
Primary completion
Oct 30, 2023
Completion
Oct 30, 2023

Study Design

Enrollment
76 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive
    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.
  • Experimental: Cohort B: Head and Neck Squamous Cell Carcinoma
    Participants 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.
  • Experimental: Cohort C: Cervical Carcinoma
    Participants with cervical carcinoma will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.
  • Experimental: Cohort D (Recurrent Advanced and/or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma)
    Participants 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.
  • Experimental: Cohort E: TMB-H + MSS Solid Tumors
    Participants 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.
  • Experimental: Cohort F: Rare Tumors (Sarcoma, Uveal Melanoma, Germ Cell)
    Participants 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.
  • Experimental: Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated)
    Participants 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.
  • Experimental: Cohort H: Ovarian Cancer
    Participants with ovarian cancer will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.

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) ]

Locations (14)

FacilityCityStateZIPSite coordinators
Mereo Investigator SitePhoenixArizona85054-
Mereo Investigator SiteGreenbraeCalifornia94904-
Mereo Investigator SiteLos AngelesCalifornia90025-
Mereo Investigator SiteJacksonvilleFlorida32224-
Mereo Investigator SiteBostonMassachusetts02215-
Mereo Investigator SiteAnn ArborMichigan48109-
Mereo Investigator SiteRochesterMinnesota55905-
Mereo Investigator SiteNew YorkNew York10065-
Mereo Investigator SiteDurhamNorth Carolina27710-
Mereo Investigator SiteOklahoma CityOklahoma73104-
Mereo Investigator SiteNashvilleTennessee37203-
Mereo Investigator SiteHoustonTexas77030-
Mereo Investigator SiteWest Valley CityUtah84119-
Mereo Investigator SiteFairfaxVirginia22031-

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Mereo Investigator Site· Phoenix, AZMereo Investigator Site· Greenbrae, CAMereo Investigator Site· Los Angeles, CAMereo Investigator Site· Jacksonville, FLMereo Investigator Site· Boston, MAMereo Investigator Site· Ann Arbor, MI

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