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Trial record 1 of 1 for:    NCT02472977
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Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors (CXCessoR4)

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ClinicalTrials.gov Identifier: NCT02472977
Recruitment Status : Terminated (Trial terminated because of lack of efficacy in the short term acute phase)
First Posted : June 16, 2015
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine whether the combination of Ulocuplumab and Nivolumab is safe and effective in the treatment of pancreatic cancer and small cell lung cancer.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: Ulocuplumab Drug: Nivolumab Phase 1 Phase 2

Detailed Description:
  • Intervention model: Single group for Stage 1 DLT, then Parallel
  • Data Monitoring Committee: No (Stage 1) Yes (Stage 2 Randomized Ph2)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1/2 Study of the Safety and Efficacy of Ulocuplumab Combined With Nivolumab in Subjects With Advanced or Metastatic Solid Tumors
Actual Study Start Date : July 13, 2015
Actual Primary Completion Date : January 27, 2017
Actual Study Completion Date : January 27, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Active Comparator: BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC)
Small cell lung cancer (SCLC)
Drug: Ulocuplumab
Other Name: BMS-936564

Drug: Nivolumab
Active Comparator: BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC)
Pancreatic cancer (PAC)
Drug: Ulocuplumab
Other Name: BMS-936564

Drug: Nivolumab



Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs [ Time Frame: From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months) ]
    The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported.

  2. Objective Response Rate (ORR) Per RECIST 1.1 Criteria [ Time Frame: From first dose until disease progression or treatment discontinuation (assessed up to January 2017, approximately 18 months) ]
    ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants. BOR is defined as the best response designation recorded between the first dose date and the date of progression per RECIST 1.1, or the date of subsequent anti-cancer therapy, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes 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. Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, referencing the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study.

  3. Overall Survival (OS) [ Time Frame: From date of randomization to date of death (assessed up to study completion, approximately 18 months) ]
    If a Phase 2 comparative study is initiated and, for PAC only: Overall Survival is defined as the time from randomization to date of death due to any cause.

  4. Number of Participants With Laboratory Abnormalities [ Time Frame: From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months) ]
    The number of participants who experienced on-study Grade 3 or 4 laboratory abnormalities (without Grade 3 or 4 abnormality at baseline) was reported for each arm.

  5. Number of Participants With Electrocardiogram Abnormalities [ Time Frame: From first dose to date of last dose plus 30 days ]
    The number of participants experiencing electrocardiogram abnormalities was reported for each arm


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: From first dose to date of progression (assessed up to January 2017, approximately 18 months) ]
    Progression-free survival is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by the investigator according to RECIST 1.1 criteria, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. PFS was not assessed for this study due to the small number of participants.



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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 BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • SCLC or PAC that is advanced or has spread to other parts of the body
  • Treated with at least one other chemotherapy that did not work or where cancer relapsed
  • Minimal limitations on activities of daily living as measured by Eastern Cooperative Oncology Group (ECOG) score of 0-1

Exclusion Criteria:

  • Patients with cancer that spread to the brain
  • Active, known or suspected autoimmune disease
  • Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)

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): NCT02472977


Locations
United States, Colorado
University Of Colorado Hosp
Aurora, Colorado, United States, 80045
United States, Indiana
Indiana University Health
Indianapolis, Indiana, United States, 46202
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, New York
Columbia University Medical Center (Cumc)
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Finland
Local Institution
Helsinki, Finland, 00029
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Statistical Analysis Plan  [PDF] January 13, 2016
Study Protocol  [PDF] January 13, 2016


Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02472977     History of Changes
Other Study ID Numbers: CA212-115
2015-000136-15 ( EudraCT Number )
First Posted: June 16, 2015    Key Record Dates
Results First Posted: March 29, 2018
Last Update Posted: March 29, 2018
Last Verified: March 2018

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

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs