IIS: Vantrelimab in ECOG 2 patients — a single-centre prospective study

EVP-0004Investigator-initiated studyVantrexaActiveRisk mediumSponsor: Investigator

KWDr. Kenji WatanabeCountry Medical Lead, Japan

Evidence gap: Outcomes in elderly and ECOG 2 patients
Objective: SO-VTX-01
Research question: Is vantrelimab tolerable and active in ECOG 2 patients excluded from VOYAGE-1?
Design: Single-arm, investigator-sponsored, n=40
Investigator: Dr. Hiroshi Hayashi
Institution: National Cancer Center Tokyo
Countries: Japan
Data source: Prospective
Submitted: 06 Oct 2025
Approved: 30 Jan 2026 (116 days)
Contract / ethics: ExecutedEthics approved
Budget / spend: $142k of $380k
37%
Enrolment: 17 of 40
43%

Workflow

Evidence-generation workflow (PRD §17); Rejected is a terminal branch from any review stage.

Current stageActiveDemo action — not persisted

Review stages passed, derived from workflow position

Study milestones from CTMS (INT-06)

Milestone	Due	Completed	Status	Evidence / note	Late days
First patient in	01 Apr 2026	09 Apr 2026	Completed	Evidence missing	+8
50% enrolment	30 Sept 2026	—	At risk	17/40 enrolled	0

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Insights citing the evidence gap "Outcomes in elderly and ECOG 2 patients"

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