Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A ONO-4578 dose 1 + Opdivo® + SOC (mFOLFOX6 + bevacizumab) | Experimental |
| |
| Arm B ONO-4578 dose 2 + Opdivo® + SOC (mFOLFOX6 + bevacizumab) | Experimental |
| |
| Arm C SOC (mFOLFOX6+bevacizumab) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-4578 | Drug | ONO-4578 tablets once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) per Blinded Independent Central Review (BICR) | 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. | From randomization to the end of treatment (Up to 39 months) |
| Number of participants with Adverse Events (AEs) | 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. | From first dose to 28 days post last dose |
| Number of participants with Serious Adverse Events (SAEs) | 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. | From first dose to 28 days post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) per Investigator assessment | ORR (assessed by site Investigator 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 site Investigator per RECIST v1.1 divided by the total number of participants. | From randomization to the end of treatment (Up to 39 months) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| North America Clinical Trial Support Desk | Contact | +18665877745(Toll-Free) | clinical_trial@ono-pharma.com | |
| International Clinical Trial Support Desk | Contact | +17162141777(Standard) | clinical_trial@ono-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Project Leader | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Recruiting | Phoenix | Arizona | 85054 | United States | |
| USC Norris Comprehensive Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| Overall Survival (OS) | OS is defined as the time between the date of randomization and the date of death due to any cause. | From randomization to the end of treatment (Up to 39 months) |
| Progression-Free Survival (PFS) by BICR | PFS by BICR is defined as the time from date of randomization to the date of the first documented progressive disease (PD) as determined by BICR per RECIST version 1.1, or the date of death due to any cause, whichever occurs first. | From randomization to the end of treatment (Up to 39 months) |
| Progression-Free Survival (PFS) by Investigator assessment | PFS by Investigator assessment is defined as the time from date of randomization to the date of the first documented progressive disease (PD) as determined by site Investigator per RECIST version 1.1, or the date of death due to any cause, whichever occurs first. | From randomization to the end of treatment (Up to 39 months) |
| Best overall response (BOR) by BICR | BOR is defined as the best response designation, recorded between the start of the study intervention and the date of the initial objectively documented PD per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first. | From randomization to the end of treatment (Up to 39 months) |
| Best overall response (BOR) by Investigator assessment | BOR is defined as the best response designation, recorded between the start of the study intervention and the date of the initial objectively documented PD per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first. | From randomization to the end of treatment (Up to 39 months) |
| Duration of response (DOR) by BICR | DOR is defined as the time between the date of first confirmed CR or PR to the date of the first documented PD per RECIST v1.1 or death due to any cause, whichever occurs first. | From randomization to the end of treatment (Up to 39 months) |
| Duration of response (DOR) by Investigator assessment | DOR is defined as the time between the date of first confirmed CR or PR to the date of the first documented PD per RECIST v1.1 or death due to any cause, whichever occurs first. | From randomization to the end of treatment (Up to 39 months) |
| Disease Control Rate (DCR) by BICR | DCR is defined as the percentage of participants whose BOR is determined to be CR, PR, or stable disease (SD). | From randomization to the end of treatment (Up to 39 months) |
| Disease Control Rate (DCR) by Investigator assessment | DCR is defined as the percentage of participants whose BOR is determined to be CR, PR, or stable disease (SD). | From randomization to the end of treatment (Up to 39 months) |
| Time to Response (TTR) by BICR | TTR is defined as the time from the date of randomization to the date of first confirmed CR or PR. | From randomization to the end of treatment (Up to 39 months) |
| Time to Response (TTR) by Investigator assessment | TTR is defined as the time from the date of randomization to the date of first confirmed CR or PR. | From randomization to the end of treatment (Up to 39 months) |
| Maximum percent change in the sum of the diameters of the target lesions by BICR | In participants who have target lesions at baseline and at least 1 post-baseline imaging evaluation, the maximum percent change in the sum of diameters of target lesions is the percent change at the point of the minimum sum of diameters of the target lesions. | From randomization to the end of treatment (Up to 39 months) |
| Maximum percent change in the sum of the diameters of the target lesions by Investigator assessment | In participants who have target lesions at baseline and at least 1 post-baseline imaging evaluation, the maximum percent change in the sum of diameters of target lesions is the percent change at the point of the minimum sum of diameters of the target lesions. | From randomization to the end of treatment (Up to 39 months) |
| Progression-Free Survival of second line therapy (PFS2) by Investigator assessment | PFS2 is defined as the time from date of randomization to the date of an overall response of PD after subsequent anti-cancer therapy, initiating date of a second subsequent anti-cancer therapy, or date of death from any cause, whichever occurs first. | From randomization to the end of treatment (Up to 39 months) |
| Recruiting |
| Los Angeles |
| California |
| 90033 |
| United States |
| Rocky Mountain Cancer Centers, LLP | Recruiting | Lone Tree | Colorado | 80124 | United States |
| Mayo Clinic Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
| Advent Health | Recruiting | Orlando | Florida | 32803 | United States |
| May Clinic Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
| The Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43221 | United States |
| Thomas Jefferson University, Sidney Kimmel Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Baylor Scott & White Medical Center | Recruiting | Temple | Texas | 76508 | United States |
| Virginia Oncology Associates | Recruiting | Norfolk | Virginia | 23502 | United States |
| Blue Ridge Cancer Care | Recruiting | Salem | Virginia | 24153 | United States |
| Princess Margaret Cancer Centre- University Health Network | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| CHU Besançon - Hôpital Jean Minjoz | Recruiting | Besançon | Doubs | France |
| CHU Bordeaux - Hôpital Haut-Lévêque | Recruiting | Pessac | Gironde | France |
| Chru De Nantes Hotel-Dieu | Recruiting | Nantes | Loire Atlantique | France |
| Hôpital de la Timone | Recruiting | Marseille | Marseille | France |
| Hôpital Européen Georges Pompidou | Recruiting | Paris | Paris | France |
| Hôpital Saint-Antoine | Recruiting | Paris | Paris | France |
| Centre Leon Berard | Recruiting | Lyon | Rhone | France |
| CHU Poitiers - Hôpital la Milétrie | Recruiting | Poitiers | Vienne | France |
| Azienda Socio Sanitaria Territoriale Niguarda | Recruiting | Milan | Italy | Italy |
| Istituto Clinico Humanitas | Recruiting | Milan | Italy | Italy |
| Istituto Europeo di Oncologia | Recruiting | Milan | Italy | Italy |
| Istituto Nazionale Tumori Fondazione G. Pascale | Recruiting | Naples | Napoli | Italy |
| IOV-Istituto Oncologico | Recruiting | Padova | Padova | Italy |
| Kobe City Medical Center General Hospital | Recruiting | Hyōgo | Kobe-shi | Japan |
| National Hospital Organization Osaka National Hospital | Recruiting | Osaka | Osaka-shi | Japan |
| Osaka General Medical Center | Recruiting | Osaka | Osaka-shi | Japan |
| Osaka International Cancer Institute | Recruiting | Osaka | Osaka-shi | Japan |
| Hosptial Universitari Vall d'Hebron | Recruiting | Barcelona | Barcelona | Spain |
| Hospital Universitario Reina Sofia | Recruiting | Córdoba | Córdoba | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | Madrid | Spain |
| Hospital Universitario Virgen del Rocio | Recruiting | Seville | Sevilla | Spain |
| Hospital Regional Universitario de Malaga | Recruiting | Málaga | Spain | Spain |
| Hospital General Universitario de Valencia | Recruiting | Valencia | Valencia | Spain |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| D000068258 | Bevacizumab |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
Not provided
Not provided