A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors

September 22, 2025 updated by: Bristol-Myers Squibb

A Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors

The purpose of this study is to evaluate the safety profile, tolerability, drug levels, drug effects, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or nivolumab or chemotherapy plus nivolumab in participants with metastatic colorectal and pancreatic cancers.

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.
332

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 1

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

  • Australia
    • Victoria
      • Clayton, Victoria, Australia
        • Local Institution - 0028
  • Belgium
      • Brussels, Belgium, 1200
        • Local Institution - 0050
      • Edegem, Belgium, 2650
        • Local Institution - 0051
      • Leuven, Belgium, 3000
        • Local Institution - 0049
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0013
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Local Institution - 0012
      • Toronto, Ontario, Canada, M5G 1X6
        • Local Institution - 0001
  • Germany
      • Dresden, Germany, 01307
        • Local Institution - 0022
      • Heidelberg, Germany, 69120
        • Local Institution - 0007
  • Spain
      • Barcelona, Spain, 08003
        • Local Institution - 0031
      • Madrid, Spain, 28046
        • Local Institution - 0032
      • Majadahonda - Madrid, Spain, 28222
        • Local Institution - 0030
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Local Institution - 0003
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Local Institution - 0026
    • California
      • Los Angeles, California, United States, 90033
        • Local Institution - 0002
      • Los Angeles, California, United States, 90033
        • Local Institution - 0025
      • Orange, California, United States, 92868-3201
        • Local Institution - 0041
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 0015
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Local Institution - 0018
    • Florida
      • Brooksville, Florida, United States, 34613
        • Local Institution - 0048
      • St. Petersburg, Florida, United States, 33705
        • Local Institution - 0047
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Local Institution - 0005
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0033
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Local Institution - 0027
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Local Institution - 0039
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Local Institution - 0023
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0004
    • New York
      • New York, New York, United States, 10065
        • Local Institution - 0017
      • Rochester, New York, United States, 14642
        • Local Institution - 0024
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 0046
    • Ohio
      • Cleveland, Ohio, United States, 44106-5055
        • Local Institution - 0044
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 0021
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Local Institution - 0037
      • Philadelphia, Pennsylvania, United States, 19104
        • Local Institution - 0014
      • Philadelphia, Pennsylvania, United States, 19107
        • Local Institution - 0020
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Local Institution - 0045
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Local Institution - 0034
      • Nashville, Tennessee, United States, 37232
        • Local Institution - 0038
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Local Institution - 0016
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Local Institution - 0042

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Must have metastatic colorectal or pancreatic cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
  • Ability to swallow pills or capsules
  • Required to undergo mandatory pre and on-treatment biopsies
  • Adequate marrow function
  • Adequate other organ functions
  • Ability to comply with study visits, treatment, procedures, pharmacokinetic (PK) and pharmacodynamic (PD) sample collection, and required study follow-up

Exclusion Criteria:

  • Histology other than adenocarcinoma (neuroendocrine or acinar cell)
  • Suspected, known, or central nervous system (CNS) metastases (Imaging required only if participants are symptomatic)
  • Active, known or suspected autoimmune disease
  • Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
  • Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity
  • Prior treatment with cysteine-cysteine chemokine receptor 2 (CCR2) and/or cysteine-cysteine chemokine receptor 5 (CCR5) inhibitors, programmed death-1 receptor (PD-1), programmed death-ligand 1 [PD(L)-1] or cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibodies
  • History of allergy to study treatments or any of its components of the study arm that participant is enrolling

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: Part 1 Arm A [First-line (1L) Colorectal]: BMS-813160 followed by BMS-813160 + FOLFIRI
FOLFIRI: FOL (folinic acid [leucovorin]) F (fluorouracil [5-fluorouracil]) IRI (irinotecan [CAMPTOSAR])
Drug: Leucovorin
Specified dose on specified days
Drug: Irinotecan
Specified dose on specified days
Drug: BMS-813160
Specified dose on specified days
Drug: 5-fluorouracil (5-FU)
Specified dose on specified days
Experimental: Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel
Drug: Gemcitabine
Specified dose on specified days
Drug: BMS-813160
Specified dose on specified days
Drug: Nab-paclitaxel
Specified dose on specified days
Experimental: Part 1 Arm C [2L Pancreatic & 2/3L Colorectal MSS]: BMS-813160 followed by BMS-813160 + Nivolumab
2L: Second-line 2/3L: Second/third-line MSS: Microsatellite stable
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: BMS-813160
Specified dose on specified days
Experimental: Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI
Drug: Leucovorin
Specified dose on specified days
Drug: Irinotecan
Specified dose on specified days
Drug: BMS-813160
Specified dose on specified days
Drug: 5-fluorouracil (5-FU)
Specified dose on specified days
Experimental: Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI
Drug: Leucovorin
Specified dose on specified days
Drug: Irinotecan
Specified dose on specified days
Drug: BMS-813160
Specified dose on specified days
Drug: 5-fluorouracil (5-FU)
Specified dose on specified days
Experimental: Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRI
Drug: Leucovorin
Specified dose on specified days
Drug: Irinotecan
Specified dose on specified days
Drug: 5-fluorouracil (5-FU)
Specified dose on specified days
Experimental: Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxel
Drug: Gemcitabine
Specified dose on specified days
Drug: BMS-813160
Specified dose on specified days
Drug: Nab-paclitaxel
Specified dose on specified days
Experimental: Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Gemcitabine
Specified dose on specified days
Drug: BMS-813160
Specified dose on specified days
Drug: Nab-paclitaxel
Specified dose on specified days
Experimental: Part 2 Arm B Cohort 3c [1L Pancreatic]: Gemcitabine/Nab-paclitaxel
Drug: Gemcitabine
Specified dose on specified days
Drug: Nab-paclitaxel
Specified dose on specified days
Experimental: Part 2 Arm C Cohort 4 [2L Pancreatic]: BMS-813160 + Nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: BMS-813160
Specified dose on specified days
Experimental: Part 2 Arm C Cohort 5 [2/3L Colorectal MSS]: BMS-813160 + Nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: BMS-813160
Specified dose on specified days
Experimental: Part 2 Arm D Cohort 7 [2L Pancreatic]: BMS-813160 Monotherapy
Drug: BMS-813160
Specified dose on specified days
Experimental: Part 2 Arm D Cohort 8 [2/3L Colorectal MSS]: BMS-813160 Monotherapy
Drug: BMS-813160
Specified dose on specified days

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
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: From first dose up to 100 days post last dose, up to approximately 3 years
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 up to 100 days post last dose, up to approximately 3 years
Number of Participants Experiencing Serious Adverse Events (SAEs)
Time Frame: From first dose up to 100 days post last dose, up to approximately 3 years
A Serious Adverse Event (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 up to 100 days post last dose, up to approximately 3 years
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Time Frame: From first dose up to 100 days post last dose, up to approximately 3 years
Dose-limiting toxicities (DLTs) are severe adverse effects (AEs) that are attributed to BMS-813160 or the combination regimen and define the maximum tolerated dose of a medicine. DLTs will be defined based on the incidence, duration and grade of AEs for which no alternate cause can be identified. AEs will be evaluated according to the NCI CTCAE v4.03. The incidence of DLT(s) during the first 6 weeks of treatment in Part 1 (the DLT evaluation period) and 4 weeks for Part 2 will be used.
From first dose up to 100 days post last dose, up to approximately 3 years
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
Time Frame: From first dose up to 100 days post last dose, up to approximately 3 years
An Adverse Event (AE) leading to discontinuation 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 that leads to the discontinuation of study 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 up to 100 days post last dose, up to approximately 3 years
Number of Participants Who Died
Time Frame: From first dose up to 100 days post last dose, up to approximately 3 years
The number of participants who died within 100 days after receiving their last dose
From first dose up to 100 days post last dose, up to approximately 3 years
Number of Participants Experiencing Laboratory Abnormalities
Time Frame: From first dose up to 100 days post last dose, up to approximately 3 years
The number of participants experiencing laboratory abnormalities in pre-specified selected parameters during the treatment period per CTCAE (Version 4). Laboratory abnormalities 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 up to 100 days post last dose, up to approximately 3 years
Vital Signs
Time Frame: From first dose to 100 days post last dose, up to approximately 3 years
Vital sign measurements at baseline and at the end of treatment. Baseline evaluations will be defined as evaluations with a date on or prior to the day of first dose of study treatment.
From first dose to 100 days post last dose, up to approximately 3 years
Number of Participants With Out-of-Range Electrocardiograms (ECG)
Time Frame: From baseline up to 100 days post last dose
The number of participants with ECG measurements outside of the range pre-specified in the protocol.
From baseline up to 100 days post last dose
Percent Change in Regulatory T Cells (Treg) in Tumor Samples
Time Frame: From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1)
The percent change in Regulatory T Cells (Treg) were taken at prespecified timepoints. Baseline is defined as the last non-missing value prior to the first dosing.
From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1)
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
Time Frame: From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1)
The percent change in Tumor-Associated Macrophages (TAMs) were taken at prespecified timepoints. Baseline is defined as the last non-missing value prior to the first dosing.
From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1)
Objective Response Rate (ORR)
Time Frame: From first dose until disease progression, or the last response recorded (up to approximately 5 years)

Objective Response Rate (ORR) as determined by Investigator was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. Progression is defined as at least 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm.

RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. Complete response (CR)= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose until disease progression, or the last response recorded (up to approximately 5 years)
Duration of Response (DoR)
Time Frame: From first dose up to date of disease progression or death, whichever occurs first (up to approximately 5 years)

Duration of Response (DOR), computed for all treated participants with a best overall response (BOR) of complete response (CR) or partial response (PR), is defined as the time between the date of first response (CR or PR) and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause, whichever occurs first, ie., DOR = disease progression date/death date -first response date + 1. For participants who remain alive and have not progressed, DOR will be censored on the date of their last tumor assessment.

CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose up to date of disease progression or death, whichever occurs first (up to approximately 5 years)
Progression Free Survival (PFS) Rate at 24 Weeks
Time Frame: From first dose up to Week 24

PFS rate is defined as the proportion of participants who were progression free at Week 24. PFS is defined as the time from first dose to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Progression is defined at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm.

Complete response (CR)= Disappearance of all target lesions. Pathological lymph nodes must have short axis reduction to < 10 mm. Partial response (PR)= At least 30% decrease in sum of diameters of target lesions.

Participants who died w/o prior progression were considered progressed on death date. Those alive and not progressed were censored on the last tumor assessment date. Those who started subsequent therapy without reported progression were censored at last tumor assessment prior to subsequent therapy. Those without post-baseline tumor assessment and alive were censored at first dose.
From first dose up to Week 24

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
Maximim Concentration (Cmax)
Time Frame: From first dose up to the prespecified timepoints, C0D1, C0D14, and C2D1
Cmax is defined as the maximum plasma concentration of the analytes at the prespecified timepoints.
From first dose up to the prespecified timepoints, C0D1, C0D14, and C2D1
Time to Maximum Concentration (Tmax)
Time Frame: From first dose up to the prespecified timpoints, C0D1, C0D14, AND C2D1
Tmax is defined as the time in hours of the maximum observed plasma concentration
From first dose up to the prespecified timpoints, C0D1, C0D14, AND C2D1
Trough Observed Plasma Concentration (Ctrough)
Time Frame: From first dose up to prespecified timepoints, C0D1, C5D1, C0D1, C1D15, C5D1
Ctrough is defined as the concentration reached by a drug immediately before the next dose is administered
From first dose up to prespecified timepoints, C0D1, C5D1, C0D1, C1D15, C5D1
Area Under Curve (AUC) 0-8
Time Frame: From first dose up to prespecified timepoints- C0D1, C2D1
Area Under Curve (AUC) is defined as the area under the plot of plasma concentration of a drug versus time after dosage measured at 8 hours post-dose
From first dose up to prespecified timepoints- C0D1, C2D1
Area Under Curve (AUC) 0-24
Time Frame: From first dose up to prespecified timepoints-C0D1, C2D1
Area Under Curve (AUC) is defined as the area under the plot of plasma concentration of a drug versus time after dosage measured at 8 hours post-dose
From first dose up to prespecified timepoints-C0D1, C2D1
Apparent Total Body Clearance (CLT/F)
Time Frame: From first dose up to prespecified timepoints-C0D1, C2D14
The total body clearance (CLT/F) is defined as the volume of plasma completely cleared of drug per unit time
From first dose up to prespecified timepoints-C0D1, C2D14
Renal Clearance (CLR)
Time Frame: From first dose up to prespecified timepoints-C0D1, C0D14
Renal clearance is defined as the rate at which the analytes were removed from the plasma by the kidneys.
From first dose up to prespecified timepoints-C0D1, C0D14
Number of Participants Who Were Anti-Drug Antibody (ADA) Positive
Time Frame: From first dose up to prespecified timepoints-C1D1, C1D15, C2D1, C3D1, C5D1, C9D1
The number of participants who are anti-drug antibody positive. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment. ADA-positive sample is in a participant who is baseline ADA negative or with an ADA titer to be at least 4-fold or greater than baseline positive titer.
From first dose up to prespecified timepoints-C1D1, C1D15, C2D1, C3D1, C5D1, C9D1

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

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 Squibb

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.
August 8, 2017

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.
April 6, 2023

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.
June 14, 2023

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).
June 9, 2017

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.
June 9, 2017

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.
June 14, 2017

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.
October 9, 2025

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.
September 22, 2025

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.
September 1, 2025

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.
  • CV202-103
  • 2017-001725-40 (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.

Clinical Trials on Colorectal Cancer

  • NCT04597151
    Completed
    Diet Education Program for Stage I-IV Colorectal Cancer Survivors
    Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8
  • NCT03781778
    Terminated
    Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors
    Rectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8
  • NCT04832763
    Active, not recruiting
    Medical and Psychosocial Issues in Adolescents and Young Adults With Colorectal Cancer
    Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8
  • NCT04739072
    Recruiting
    Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study
    Colorectal Adenocarcinoma | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8
  • NCT03796884
    Active, not recruiting
    Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
    Colorectal Adenoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage 0 Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal Cancer AJCC v8
  • NCT03844620
    Active, not recruiting
    Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer
    Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Refractory Colorectal Carcinoma
  • NCT03520283
    Completed
    Systems Support Mapping in Guiding Self-Management in Stage I-III Colorectal Cancer Survivors
    Cancer Survivor | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal Cancer AJCC v8 | Stage IIC Colorectal Cancer AJCC v8
  • NCT01570452
    Completed
    Matrilysin Expression in Different Stages of Colorectal Tumors (MMP7)
    Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Cancer Stage 0 | Colorectal Cancer Stage I
  • NCT03300609
    Terminated
    5-FU Based Maintenance Therapy in RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX Plus Panitumumab
    Stage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer AJCC v7
  • NCT03800602
    Completed
    Nivolumab and Metformin in Patients With Treatment Refractory MSS Colorectal Cancer
    Colorectal Cancer Metastatic | Colorectal Adenocarcinoma | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Refractory Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal Carcinoma | Stage IVC Colorectal Cancer

Clinical Trials on Nivolumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings