A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT06948448
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ONO-4578 — DRUG
    ONO-4578 tablets once a day
  • Opdivo® — DRUG
    Specified dose on specified days
  • Oxaliplatin — DRUG
    Specified dose on specified days
  • 5-Fluorouracil — DRUG
    Specified dose on specified days
  • Bevacizumab — DRUG
    Specified dose on specified days
  • Leucovorin — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.

Key Dates

Start date
Nov 18, 2025
Status verified
May 2026
Primary completion
Feb 15, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A ONO-4578 dose 1 + Opdivo® + SOC (mFOLFOX6 + bevacizumab)
  • Experimental: Arm B ONO-4578 dose 2 + Opdivo® + SOC (mFOLFOX6 + bevacizumab)
  • Active Comparator: Arm C SOC (mFOLFOX6+bevacizumab)

Primary Outcome Measure

Overall Response Rate (ORR) per Blinded Independent Central Review (BICR) [ Time Frame: From randomization to the end of treatment (Up to 39 months) ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054-
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Rocky Mountain Cancer Centers, LLPLone TreeColorado80124-
Mayo Clinic FloridaJacksonvilleFlorida32224-
Advent HealthOrlandoFlorida32803-
May Clinic RochesterRochesterMinnesota55905-
The Ohio State University Comprehensive Cancer CenterColumbusOhio43221-
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107-
Baylor Scott & White Medical CenterTempleTexas76508-
Virginia Oncology AssociatesNorfolkVirginia23502-
Blue Ridge Cancer CareSalemVirginia24153-

Find similar trials in Phoenix, AZ

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Mayo Clinic Arizona· Phoenix, AZUSC Norris Comprehensive Cancer Center· Los Angeles, CARocky Mountain Cancer Centers, LLP· Lone Tree, COMayo Clinic Florida· Jacksonville, FLAdvent Health· Orlando, FLMay Clinic Rochester· Rochester, MN

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