CheckMate 816: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 816

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC) (CheckMate 816)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223597

Enrollment

642

Registered

2017-07-24

Start date

2017-07-18

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

Non-Small Cell Lung Cancer

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue Lung function capacity capable of tolerating the proposed lung surgery Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Available tissue of primary lung tumor

Exclusion criteria

Exclusion criteria: Presence of locally advanced, inoperable or metastatic disease Participants with active, known or suspected autoimmune disease Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)

Design outcomes

Primary

Measure	Time frame
efficacy Event-Free Survival Pathological Complete Response	—

Secondary

Measure	Time frame
efficacy Overall survival (OS) Major pathological response (MPR)	—

Countries

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

Outcome results

None listed

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