An Investigational Immunotherapy Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Colorectal Cancer That Has Spread (CheckMate 9X8)

October 27, 2023 updated by: Bristol-Myers Squibb

An Open-Label Exploratory Phase 2/3 Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Metastatic Colorectal Cancer

This purpose of this study is to evaluate nivolumab (BMS-936558) in combination with standard of care (SOC) chemotherapy with bevacizumab for the treatment of first-line metastatic colorectal cancer (mCRC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
196

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0017
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Local Institution - 0015
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0014
    • Quebec
      • Montreal, Quebec, Canada, H2X 1P1
        • Local Institution - 0048
      • Quebec City, Quebec, Canada, G1J 1Z4
        • Local Institution - 0012
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Local Institution - 0013
      • Trois-Rivieres, Quebec, Canada, G8Z 3R9
        • Local Institution - 0016
  • Japan
    • Aichi
      • Nagoya, Aichi, Japan, 4648681
        • Local Institution - 0055
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Local Institution - 0051
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 4118777
        • Local Institution - 0050
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Local Institution - 0009
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0043
      • Madrid, Spain, 28034
        • Local Institution - 0042
      • Majadahonda - Madrid, Spain, 28222
        • Local Institution - 0041
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • UAB Comprehensive Cancer Center
    • California
      • Los Angeles, California, United States, 90033
        • Local Institution - 0004
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 0010
      • Denver, Colorado, United States, 80218
        • Local Institution - 0027
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Local Institution - 0020
    • Florida
      • Miami, Florida, United States, 33176
        • Local Institution - 0039
      • Saint Petersburg, Florida, United States, 33705
        • Local Institution - 0047
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Local Institution - 0033
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Local Institution - 0044
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Local Institution - 0021
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0003
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0049
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0052
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0053
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Local Institution - 0035
      • Rochester, Minnesota, United States, 55905
        • Local Institution - 0002
    • Nebraska
      • Papillion, Nebraska, United States, 68046
        • Local Institution - 0032
    • Nevada
      • Henderson, Nevada, United States, 89074
        • Local Institution - 0029
    • New York
      • Johnson City, New York, United States, 13790
        • Local Institution - 0031
      • New York, New York, United States, 10016
        • Local Institution - 0046
    • North Carolina
      • Charlotte, North Carolina, United States, 28262
        • Levine Cancer Institute
    • Oregon
      • Portland, Oregon, United States, 97227
        • Local Institution - 0038
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Local Institution - 0005
      • Pittsburgh, Pennsylvania, United States, 15212
        • Local Institution - 0024
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Local Institution - 0023
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Oncology & Hematology - Univ. of TN
      • Nashville, Tennessee, United States, 37203
        • Local Institution - 0019
    • Texas
      • Bedford, Texas, United States, 76022
        • Local Institution - 0026
      • Dallas, Texas, United States, 75246
        • Local Institution - 0034
      • Fort Worth, Texas, United States, 76104
        • Local Institution - 0037
      • San Antonio, Texas, United States, 78217
        • Local Institution - 0040
      • Tyler, Texas, United States, 75702
        • Local Institution - 0036
    • Virginia
      • Richmond, Virginia, United States, 23229
        • Local Institution - 0025
      • Roanoke, Virginia, United States, 24014
        • Local Institution - 0028
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Local Institution - 0006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed metastatic colorectal cancer, not amenable to curative resection
  • No prior chemotherapy for metastatic colorectal cancer
  • ECOG Performance Status of 0-1
  • Ability to provide adequate tissue sample

Exclusion Criteria:

  • Patients with clinically relevant medical history, including autoimmune disease, cardiovascular disease, hepatic disease or bleeding disorders
  • 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 checkpoint pathways
  • Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A
Nivo + SOC
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Fluorouracil
Specified dose on specified days
Drug: Oxaliplatin
Specified dose on specified days
Drug: Leucovorin
Specified dose on specified days
Other Names:
  • Calcium Folinate
Drug: Bevacizumab
Specified dose on specified days
Other Names:
  • Avastin
Active Comparator: Arm B
SOC
Drug: Fluorouracil
Specified dose on specified days
Drug: Oxaliplatin
Specified dose on specified days
Drug: Leucovorin
Specified dose on specified days
Other Names:
  • Calcium Folinate
Drug: Bevacizumab
Specified dose on specified days
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
Time Frame: From randomization to up to the date of the first documented progression (up to 16 months)
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by BICR (per RECIST 1.1), or death due to any cause, whichever occurs first. Baseline tumor assessment is defined as tumor scans prior to or on randomization date. Participants who did not have documented progression per BICR and who did not die or participants who started any subsequent anti-cancer therapy without a prior reported progression per BICR will be censored at the date of the last tumor assessment on or prior to initiation of the subsequent anticancer therapy, if any. Participants who die without a reported prior progression per BICR will be considered to have progressed on the date of death. Participants who did not have any baseline or post baseline tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date.
From randomization to up to the date of the first documented progression (up to 16 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) Per Investigator Assessment
Time Frame: From randomization up to the date of the first documented progression (up to approximately 44 months)
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by Investigator Assessment, or death due to any cause, whichever occurs first. Baseline tumor assessment is defined as tumor scans prior to or on randomization date. Participants who did not have documented progression per Investigator Assessment and who did not die or participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the date of the last tumor assessment on or prior to initiation of the subsequent anticancer therapy, if any. Participants who die without a reported prior progression per Investigator Assessment will be considered to have progressed on the date of death. Participants who did not have any baseline or post baseline tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date.
From randomization up to the date of the first documented progression (up to approximately 44 months)
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
Time Frame: From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months)
ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response designation as determined by BICR per RECIST 1.1, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm.
From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months)
Objective Response Rate (ORR) Per Investigator Assessment
Time Frame: From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months)
ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response designation as determined by tumor assessments by the Investigator per RECIST 1.1, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm.
From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months)
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
Time Frame: From randomization up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 44 months)
Duration of objective response (DoR) is defined as the time between the date of first confirmed complete response (CR) or partial response (PR) to the date of the first documented tumor progression as assessed by the BICR based on RECIST 1.1 criteria or death due to any cause, whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm.
From randomization up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 44 months)
Duration of Response (DoR) Per Investigator Assessment
Time Frame: From randomization up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 44 months)
Duration of objective response (DoR) is defined as the time between the date of first confirmed complete response (CR) or partial response (PR) to the date of the first documented tumor progression as assessed by the investigator based on RECIST 1.1 criteria or death due to any cause, whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm.
From randomization up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 44 months)
Time to Objective Response Per Blinded Independent Central Review (BICR)
Time Frame: From the randomization date up to the date of the first confirmed CR or PR (up to approximately 44 months)
Time to objective response (TTR) is defined as the time from the randomization date to the date of the first confirmed complete response (CR) or partial response (PR) as assessed by BICR. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm. TTR is derived for responders only.
From the randomization date up to the date of the first confirmed CR or PR (up to approximately 44 months)
Time to Objective Response Per Investigator Assessment
Time Frame: From the randomization date up to the date of the first confirmed CR or PR (up to 44 months)
TTR is defined as the time from the randomization date to the date of the first confirmed complete response (CR) or partial response (PR) as assessed by investigator. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm. TTR is derived for responders only.
From the randomization date up to the date of the first confirmed CR or PR (up to 44 months)
Overall Survival (OS)
Time Frame: From the date of randomization up to the date of death (up to 44 months)
Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.
From the date of randomization up to the date of death (up to 44 months)
Number of Participants With Adverse Events (AEs)
Time Frame: From first dose to 30 days post last dose (up to 45 months)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
From first dose to 30 days post last dose (up to 45 months)
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: From first dose to 30 days post last dose (up to 45 months)
Number of participants with any grade of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine safety and tolerability. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
From first dose to 30 days post last dose (up to 45 months)
Number of Participants Experiencing Death
Time Frame: From first dose up to 6 weeks post last dose (up to 46 months)
The number of participants who died during the treatment period
From first dose up to 6 weeks post last dose (up to 46 months)
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Time Frame: From first dose up to 30 days post last dose (up to 45 months)
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
From first dose up to 30 days post last dose (up to 45 months)
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Time Frame: From first dose up to 30 days post last dose (up to 45 months)
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
From first dose up to 30 days post last dose (up to 45 months)
Disease Control Rate (DCR) Per Blinded Independent Central Review (BICR)
Time Frame: From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months)
Disease Control Rate (DCR) is defined as the percentage of participants whose Best Overall Response (BOR) is complete response (CR) or partial response (PR) or stable disease (SD). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months)
Disease Control Rate (DCR) Per Investigator
Time Frame: From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months)
Disease Control Rate (DCR) is defined as the percentage of participants whose Best Overall Response (BOR) is complete response (CR) or partial response (PR) or stable disease (SD). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ono Pharmaceutical Co. Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Suibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA209-9X8
  • 2017-003662-27 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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