A Study of Lomvastomig (RO7121661) and Tobemstomig (RO7247669) Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus

Sponsor
Hoffmann-La Roche
Study ID
NCT04785820
Phase
PHASE2
Status
Completed

Conditions

  • Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Lomvastomig — DRUG
    2100 milligrams (mg) administered by intravenous (IV) infusion once every 2 weeks on Day 1 of each 14-day cycle.
  • Tobemstomig — DRUG
    2100 mg administered by IV infusion once every 2 weeks on Day 1 of each 14-day cycle.
  • Nivolumab — DRUG
    240 mg administered by IV infusion once every 2 weeks on Day 1 of each 14-day cycle.

Study Details

This is a Phase II, randomized, blinded, active-controlled, global, multicenter study designed to evaluate the safety and efficacy of lomvastomig and tobemstomig, compared with nivolumab, in patients with advanced or metastatic esophageal squamous-cell carcinoma (ESCC) refractory or intolerant to fluoropyrimidine- or taxane- and platinum-based regimen. Following approval of the protocol amendment version 3, recruitment into the lomvastomig arm has been stopped. The decision to stop recruitment for lomvastomig was based on strategic considerations and not based on emerging safety and/or efficacy data. The benefit/risk assessment for lomvastomig remains unchanged. The study was planned to enroll participants randomized in a 1:1:1 ratio to receive lomvastomig, tobemstomig, or nivolumab. With version 3 of the protocol, recruitment into the lomvastomig arm has stopped, and moving forward, participants will be randomized in a 1:1 ratio to receive either tobemstomig or nivolumab.

Key Dates

Start date
Jun 25, 2021
Status verified
Mar 2026
Primary completion
Jan 30, 2025
Completion
Jan 30, 2025

Study Design

Enrollment
190 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lomvastomig
  • Experimental: Tobemstomig
  • Active Comparator: Nivolumab

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From randomization to death (up to approximately 38.7 months) ]

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