Recruiting NCT06948448
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ONO-4578, Opdivo®, Oxaliplatin, 5-Fluorouracil.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, France, Italy, Japan +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Open Label, Multicenter, Phase 2 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 for First-line Treatment of Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer
Overview
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.
Detailed description
Potential participants will be consented and screened for study eligibility. Eligible participants will be randomized in a 1:1:1 ratio to one of the three study intervention arms. Study intervention will be administered in 28-day treatment cycles and continued until disease progression, intolerable toxicity, Investigator decision or withdrawal of consent by the participant, or termination of the study by the Sponsor.
Interventions
- Drug ONO-4578
ONO-4578 tablets once a day - Drug Opdivo®
Specified dose on specified days - Drug Oxaliplatin
Specified dose on specified days - Drug 5-Fluorouracil
Specified dose on specified days - Drug Bevacizumab
Specified dose on specified days - Drug Leucovorin
Specified dose on specified days
Primary outcome measures
- Overall Response Rate (ORR) per Blinded Independent Central Review (BICR) [Time frame: From randomization to the end of treatment (Up to 39 months)]
- Number of participants with Adverse Events (AEs) [Time frame: From first dose to 28 days post last dose]
- Number of participants with Serious Adverse Events (SAEs) [Time frame: From first dose to 28 days post last dose]
Secondary outcome measures (12)
- Overall Response Rate (ORR) per Investigator assessment [Time frame: From randomization to the end of treatment (Up to 39 months)]
- Overall Survival (OS) [Time frame: From randomization to the end of treatment (Up to 39 months)]
- Progression-Free Survival (PFS) by BICR [Time frame: From randomization to the end of treatment (Up to 39 months)]
- Progression-Free Survival (PFS) by Investigator assessment [Time frame: From randomization to the end of treatment (Up to 39 months)]
- Best overall response (BOR) by BICR [Time frame: From randomization to the end of treatment (Up to 39 months)]
- Best overall response (BOR) by Investigator assessment [Time frame: From randomization to the end of treatment (Up to 39 months)]
- Duration of response (DOR) by BICR [Time frame: From randomization to the end of treatment (Up to 39 months)]
- Duration of response (DOR) by Investigator assessment [Time frame: From randomization to the end of treatment (Up to 39 months)]
- Disease Control Rate (DCR) by BICR [Time frame: From randomization to the end of treatment (Up to 39 months)]
- Disease Control Rate (DCR) by Investigator assessment [Time frame: From randomization to the end of treatment (Up to 39 months)]
- Time to Response (TTR) by BICR [Time frame: From randomization to the end of treatment (Up to 39 months)]
- Time to Response (TTR) by Investigator assessment [Time frame: From randomization to the end of treatment (Up to 39 months)]
Eligibility criteria
Inclusion criteria
- Histologically confirmed advanced (locally advanced or metastatic) colorectal cancer not amenable to curative resection
- ECOG Performance Status of 0-1
- No prior systemic treatment for advanced local or mCRC
- Participants whose tumor is positive for PD-L1 expression as determined at a central laboratory
Exclusion criteria
- Participants with high microsatellite instability (MSI-High), or mismatch repair deficient (dMMR) tumor
- Participants with BRAF V600E mutation
- Unable to swallow tablets.
- Participants with complication or history of interstitial lung disease, pneumonitis or pulmonary fibrosis
- Participants with an active, known or suspected autoimmune disease.
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
Other protocol-defined inclusion/exclusion criteria apply
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 11 centers
- Mayo Clinic Arizona — Phoenix
- USC Norris Comprehensive Cancer Center — Los Angeles
- Rocky Mountain Cancer Centers, LLP — Lone Tree
- Mayo Clinic Florida — Jacksonville
- Advent Health — Orlando
- May Clinic Rochester — Rochester
- The Ohio State University Comprehensive Cancer Center — Columbus
- Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia
- … and 3 more centers
France · 8 centers
- CHU Besançon - Hôpital Jean Minjoz — Besançon
- CHU Bordeaux - Hôpital Haut-Lévêque — Pessac
- Chru De Nantes Hotel-Dieu — Nantes
- Hôpital de la Timone — Marseille
- Hôpital Européen Georges Pompidou — Paris
- Hôpital Saint-Antoine — Paris
- Centre Leon Berard — Lyon
- CHU Poitiers - Hôpital la Milétrie — Poitiers
Spain · 7 centers
- Institut Catala d'Oncologia (H. Germans Trias I Pujol, ICO-Barcelona) — Badalona
- Hosptial Universitari Vall d'Hebron — Barcelona
- Hospital Universitario Reina Sofia — Córdoba
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Universitario Virgen del Rocio — Seville
- Hospital Regional Universitario de Malaga — Málaga
- Hospital General Universitario de Valencia — Valencia
Italy · 6 centers
- Azienda Socio Sanitaria Territoriale Niguarda — Milan
- Istituto Clinico Humanitas — Milan
- Istituto Europeo di Oncologia — Milan
- AOU Uni degli Studi Della Campania Lugi Vanvitelli — Naples
- Istituto Nazionale Tumori Fondazione G. Pascale — Naples
- IOV-Istituto Oncologico — Padova
Japan · 4 centers
- Kobe City Medical Center General Hospital — Hyōgo
- National Hospital Organization Osaka National Hospital — Osaka
- Osaka General Medical Center — Osaka
- Osaka International Cancer Institute — Osaka
Canada · 3 centers
- The Ottawa Hospital Cancer Centre — Ottawa
- Princess Margaret Cancer Centre- University Health Network — Toronto
- Jewish General Hospital — Montreal
Identifiers
NCT: NCT06948448 · ONO-4578-10 · jRCT2051250119