A Phase 3 Study of ONO-4538/BMS-936558 (ONO-4538-87)

Phase 3

Completed

• Conditions: Colorectal Cancer

• Registration Number: JPRN-jRCT2080224841
• Lead Sponsor: ONO PHARMACEUTICAL CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 831

Inclusion Criteria

1. Histologically confirmed recurrent or metastatic CRC irrespective of prior treatment history with chemotherapy and/or targeted agents not amenable to surgery (Applicable only during Part 1 enrollment of the study).
2. All participants must have measurable disease by CT or MRI per RECIST 1.1 criteria.
3. ECOG Performance Status <=1
4. Histologically confirmed recurrent or metastatic CRC with no prior treatment history with chemotherapy and/or targeted agents for metastatic disease and not amenable to surgery. Participants treated with adjuvant chemotherapy are eligible if disease progression occurred later than 6 months (>=6 months) after completion of chemotherapy (Applicable during Part 2 enrollment of the study).

Exclusion Criteria

1. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
2. Participants with an active, known or suspected autoimmune disease.
3. History of interstitial lung disease or pneumonitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>PFS

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>pharmacokinetics<br>-ORR<br>-OS<br>-DOR