Clinical Trials in Spain / NCT06948448
Recruiting
Phase 2
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
NCT06948448 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Colorectal Cancer
Investigational drug(s) / intervention(s)
ONO-4578: ONO-4578 tablets once a day
Opdivo®: Specified dose on specified days
Oxaliplatin: Specified dose on specified days
5-Fluorouracil: Specified dose on specified days
Bevacizumab: Specified dose on specified days
Leucovorin: Specified dose on specified days
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- Overall Response Rate (ORR) per Blinded Independent Central Review (BICR) — From randomization to the end of treatment (Up to 39 months)
ORR (assessed by BICR per RECIST v1.1) is defined as the proportion of participants with a BOR of confirmed CR or PR. The ORR will be estimated as the number of participants achieving BOR of CR or PR assessed by BICR per RECIST v1.1 divided by the total number of participants. - Number of participants with Adverse Events (AEs) — From first dose to 28 days post last dose
An AE is any untoward medical occurrence in a patient or clinical study patient, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. - Number of participants with Serious Adverse Events (SAEs) — From first dose to 28 days post last dose
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in significant disability/incapacity.
Trial sites (39)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| Rocky Mountain Cancer Centers, LLP | Lone Tree | Colorado | Recruiting |
| Mayo Clinic Florida | Jacksonville | Florida | Recruiting |
| Advent Health | Orlando | Florida | Recruiting |
| May Clinic Rochester | Rochester | Minnesota | Recruiting |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | Recruiting |
| Thomas Jefferson University, Sidney Kimmel Cancer Center | Philadelphia | Pennsylvania | Recruiting |
| Baylor Scott & White Medical Center | Temple | Texas | Recruiting |
| Virginia Oncology Associates | Norfolk | Virginia | Recruiting |
| Blue Ridge Cancer Care | Salem | Virginia | Recruiting |
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | Recruiting |
| Princess Margaret Cancer Centre- University Health Network | Toronto | Ontario | Recruiting |
| Jewish General Hospital | Montreal | Quebec | Recruiting |
| CHU Besançon - Hôpital Jean Minjoz | Besançon | Doubs | Recruiting |
| CHU Bordeaux - Hôpital Haut-Lévêque | Pessac | Gironde | Recruiting |
| Chru De Nantes Hotel-Dieu | Nantes | Loire Atlantique | Recruiting |
| Hôpital de la Timone | Marseille | Marseille | Recruiting |
| Hôpital Européen Georges Pompidou | Paris | Paris | Recruiting |
| Hôpital Saint-Antoine | Paris | Paris | Recruiting |
| Centre Leon Berard | Lyon | Rhone | Recruiting |
| CHU Poitiers - Hôpital la Milétrie | Poitiers | Vienne | Recruiting |
| Azienda Socio Sanitaria Territoriale Niguarda | Milan | Italy | Recruiting |
| Istituto Clinico Humanitas | Milan | Italy | Recruiting |
| Istituto Europeo di Oncologia | Milan | Italy | Recruiting |
| AOU Uni degli Studi Della Campania Lugi Vanvitelli | Naples | Napoli | Recruiting |
| Istituto Nazionale Tumori Fondazione G. Pascale | Naples | Napoli | Recruiting |
| IOV-Istituto Oncologico | Padova | Padova | Recruiting |
| Kobe City Medical Center General Hospital | Hyōgo | Kobe-shi | Recruiting |
| National Hospital Organization Osaka National Hospital | Osaka | Osaka-shi | Recruiting |
| Osaka General Medical Center | Osaka | Osaka-shi | Recruiting |
| Osaka International Cancer Institute | Osaka | Osaka-shi | Recruiting |
| Institut Catala d'Oncologia (H. Germans Trias I Pujol, ICO-Barcelona) | Badalona | Barcelona | Recruiting |
| Hosptial Universitari Vall d'Hebron | Barcelona | Barcelona | Recruiting |
| Hospital Universitario Reina Sofia | Córdoba | Córdoba | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Madrid | Recruiting |
| Hospital Universitario Virgen del Rocio | Seville | Sevilla | Recruiting |
| Hospital Regional Universitario de Malaga | Málaga | Spain | Recruiting |
| Hospital General Universitario de Valencia | Valencia | Valencia | Recruiting |
On this site
📄 Avastin (bevacizumab) drug profile →More Ono Pharmaceutical Co., Ltd. trials in Spain
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06948448 on ClinicalTrials.gov ↗ ← All trials in Spain