A Study to Test the Safety and Effectiveness of Nivolumab Combined With Daratumumab in Patients With Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, That Have Advanced or Have Spread

NCT ID: NCT03098550

Last Updated: 2021-07-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2020-07-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether a combination of Nivolumab and Daratumumab is safe and effective when treating Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, that have advanced or have spread.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Immunotherapy Combination

TNBC and PAC participants who are deriving clinical benefit will continue to be treated with the nivolumab plus daratumumab combination therapy

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Daratumumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab Monotherapy

NSCLC patients who are deriving clinical benefit will be treated with nivolumab monotherapy

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Daratumumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

* Patients with metastatic or advanced solid tumors
* Women with histologically or cytologically confirmed triple negative breast carcinoma
* Participants with histologically or cytologically confirmed pancreatic adenocarcinoma
* Participants with histologically or cytologically confirmed Non Small Cell Lung Cancer (NSCLC)

Exclusion Criteria

* Active brain metastases or leptomeningeal metastases.
* Any serious or uncontrolled medical disorder
* Prior malignancy active within the previous 3 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Janssen Biotech, Inc.

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pacific Shores Medical Group

Long Beach, California, United States

Site Status

University Of Colorado

Aurora, Colorado, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

University Of Michigan

Ann Arbor, Michigan, United States

Site Status

Providence Portland Medical Center

Portland, Oregon, United States

Site Status

Local Institution

St Leonards, New South Wales, Australia

Site Status

Local Institution

Edmonton, , Canada

Site Status

Local Institution

Lyon, , France

Site Status

Local Institution

Marseille, , France

Site Status

Centre Paul Strauss

Strasbourg, , France

Site Status

Universitaetsklinikum Carl Gustav Carus

Dresden, , Germany

Site Status

Medizinische Universitaetsklinik Freiburg

Freiburg im Breisgau, , Germany

Site Status

Universitaetsklinik Heidelberg

Heidelberg, , Germany

Site Status

Local Institution

Milan, , Italy

Site Status

Istituto Nazionale Tumori Fondazione Pascale

Napoli, , Italy

Site Status

Fundacion De Investigacion

San Juan, , Puerto Rico

Site Status

Hospital Gral. Univ. Gregorio Maranon

Madrid, , Spain

Site Status

Local Institution

Majadahonda - Madrid, , Spain

Site Status

Klinik Fur Onkologie

Basel, , Switzerland

Site Status

University Hospital of Lausanne

Lausanne, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Canada France Germany Italy Puerto Rico Spain Switzerland

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-000367-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA209-9GW

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.