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A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer (CheckMate 955)

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ClinicalTrials.gov Identifier: NCT03048136
Recruitment Status : Withdrawn (Business objective has changed)
First Posted : February 9, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Nivolumab Drug: Ipilimumab Phase 3

Detailed Description:
A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib/II Safety Trial of Nivolumab in Combination With Ipilimumab Administered in Participants With Chemotherapy-naive Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC) (CheckMate 955: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 955)
Estimated Study Start Date : March 9, 2018
Estimated Primary Completion Date : September 29, 2019
Estimated Study Completion Date : September 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Flat-Dose
Nivolumab flat dose + Ipilimumab
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy

Experimental: Weight-Based Dose
Nivolumab weight-based dose + Ipilimumab
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy




Primary Outcome Measures :
  1. Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events [ Time Frame: Approximately 3 months ]
  2. Incidence of high grade (Grade 3-4 and Grade 5) immune-mediated adverse events [ Time Frame: Approximately 3 months ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) [ Time Frame: Up to 24 months ]
  2. Objective Response Rate (ORR) as assessed by the Investigator using tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) [ Time Frame: Up to 24 months ]
  3. Overall survival (OS) as defined as the time from first dosing to the date of death [ Time Frame: Up to 5 years ]
  4. Duration of Response (DOR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) [ Time Frame: Up to 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Inclusion Criteria:

  • 1) Stage IV or recurrent non-Small cell lung cancer
  • 2) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • 3) Prior adjuvant or neoadjuvant chemotherapy for local, advanced disease allowed if completed at least 6 months prior to randomization

Exclusion Criteria:

  • 1) Known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma syndrome(ALK) translocations that are sensitive to targeted inhibitor therapy
  • 2) Active, known or suspected autoimmune disease or HIV infection
  • 3) Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
  • 4) Untreated Central Nervous System metastases

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048136


Locations
United States, California
Local Institution
San Francisco, California, United States, 94115
United States, Nebraska
Local Institution
Lincoln, Nebraska, United States, 68506
United States, New Jersey
Local Institution
Hackensack, New Jersey, United States, 07601
United States, Ohio
Local Institution
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Local Institution
Lancaster, Pennsylvania, United States, 17604
Local Institution
Langhorne, Pennsylvania, United States, 19047
Local Institution
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Local Institution
Charleston, South Carolina, United States, 29414
United States, Utah
Local Institution
Saint George, Utah, United States, 84770
Argentina
Local Institution
Viedma, RIO Negro, Argentina, 8500
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H1M 1B1
Germany
Local Institution
Dresden, Germany, 01307
Local Institution
Gauting, Germany, 82131
Local Institution
Gerlingen, Germany, 70839
Local Institution
Grosshansdorf, Germany, 22927
Peru
Local Institution
Lima, Peru, 27
Local Institution
Lima, Peru
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03048136     History of Changes
Other Study ID Numbers: CA209-955
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs