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ONO-4538 Phase II Rollover Study (ONO-4538-98)

NCT04566380 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2025-06-03

No results posted yet for this study

Summary

This study is intended to confirm the long-term safety of ONO-4538 in pan-tumor participants being treated with ONO-4538 monotherapy or in Combination with Other Therapies in clinical trials.

Conditions

  • Pan-tumor

Interventions

DRUG

ONO-4538

IV infusion over 30 minutes

DRUG

oxaliplatin

IV infusion over 2 hours

DRUG

S-1

Administered orally twice daily

DRUG

capecitabine

Administered orally twice daily

DRUG

bevacizumab

IV infusion over 30 minutes

DRUG

temozolomide

Administered orally once daily for 5 days every 28 days

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Project Leader · Ono Pharmaceutical Co. Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-10
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Japan
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04566380 on ClinicalTrials.gov