A Phase 1/2 Study of Nivolumab and Ipilimumab(ONO-4538-28/CA209-358)

Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab and Nivolumab Plus Ipilimumab in Subjects With Virus-Positive and Virus-Negative Solid Tumors(ONO-4538-28/CA209-358)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222984

Enrollment

600

Registered

2015-10-13

Start date

2015-10-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Virus-associated Solid Tumors

Interventions

investigational material(s) Generic name etc : Nivolumab, Ipilimumab INN of investigational material : Nivolumab, Ipilimumab Therapeutic category code : 429 Other antitumor agents Dosage and Administ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histopathologic confirmation of the following tumor types (Gastric or Gastro-Esophageal junction carcinoma, Nasopharyngeal carcinoma, Squamous cell carcinoma of cervix, vagina or vulva, Squamous cell carcinoma of the Head and Neck, Markel cell carcinoma and Squamous cell carcinoma of the anal canal and penile) 2. Measurable disease by CT or MRI 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

Exclusion criteria: 1. Active brain metastases or leptomeningeal metastases 2. Subjects with active, known or suspected autoimmune disease

Design outcomes

Primary

Measure	Time frame
safety efficacy -The safety and tolerability -The Objective response rate -The rate of surgery delay	—

Secondary

Measure	Time frame
efficacy -Progression-free survival -Overall survival -Duration of response	—

Countries

Asia except Japan, Europe, Japan, North America, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026