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An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors (CheckMate358)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02488759
Recruitment Status : Active, not recruiting
First Posted : July 2, 2015
Last Update Posted : September 10, 2020
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE June 30, 2015
First Posted Date  ICMJE July 2, 2015
Last Update Posted Date September 10, 2020
Actual Study Start Date  ICMJE October 8, 2015
Estimated Primary Completion Date August 4, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • The safety and tolerability will be measured by the incidence of drug-related adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 6 months after the last patient receives their first dose ]
  • Objective response rate [ Time Frame: 6 months after the last patient receives their first dose ]
  • Rate of surgery delay [ Time Frame: 6 months after the last patient receives their first dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2015)
  • The safety and tolerability will be measured by the incidence of drug-related adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 6 months after the last patient receives their first dose ]
  • The investigator-assessed objective response rate (ORR) of nivolumab monotherapy in subjects in the metastatic cohort [ Time Frame: 6 months after the last patient receives their first dose ]
  • Rate of surgery delay [ Time Frame: 6 months after the last patient receives their first dose ]
    Rate of surgery delay which is defined as the proportion of subjects in the neoadjuvant cohort with surgery delayed > 4 weeks due to a drug related AE
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
  • Progression-free survival [ Time Frame: Approximately 3 years ]
  • Overall survival [ Time Frame: Approximately 3 years ]
  • Duration of response [ Time Frame: Approximately 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2015)
  • The percent change from baseline of immune cells of viral specific T cells in tumor specific subsets of nivolumab treated subjects [ Time Frame: Approximately 3 years ]
  • The percent change from baseline of select immune activation/inhibitory molecules of viral specific T cells in tumor specific subsets of nivolumab treated subjects [ Time Frame: Approximately 3 years ]
  • Progression-free survival in subjects with nivolumab monotherapy [ Time Frame: Approximately 3 years ]
  • Overall survival in subjects with nivolumab monotherapy [ Time Frame: Approximately 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors
Official Title  ICMJE Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherapy and Nivolumab Combination Therapy in Subjects With Virus-Positive and Virus-Negative Solid Tumors
Brief Summary

The purpose of this study to investigate the safety and effectiveness of nivolumab, and nivolumab combination therapy, to treat patients who have virus-associated tumors. Certain viruses have been known to play a role in tumor formation and growth. This study will investigate the effects of the study drugs, in patients who have the following types of tumors:

  • Anal canal cancer-No longer enrolling this tumor type
  • Cervical cancer
  • Epstein Barr Virus (EBV) positive gastric cancer-No longer enrolling this tumor type
  • Merkel Cell Cancer
  • Penile cancer-No longer enrolling this tumor type
  • Vaginal and vulvar cancer-No longer enrolling this tumor type
  • Nasopharyngeal Cancer - No longer enrolling this tumor type
  • Head and Neck Cancer - No longer enrolling this tumor type
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Various Advanced Cancer
Intervention  ICMJE
  • Drug: Nivolumab
  • Drug: Ipilimumab
  • Drug: Relatlimab
    Other Names:
    • BMS-986016
    • Anti-LAG 3
  • Drug: Daratumumab
    Other Name: Darzalex
Study Arms  ICMJE
  • Experimental: Neoadjuvant Cohort

    Nivolumab intravenous infusion as specified

    **Not participating: Japan, Korea, and Taiwan

    Intervention: Drug: Nivolumab
  • Experimental: Metastatic Monotherapy Cohort
    Nivolumab intravenous infusion as specified
    Intervention: Drug: Nivolumab
  • Experimental: Nivolumab plus Ipilimumab Cohort

    Nivolumab intravenous infusion as specified with Ipilimumab intravenous infusion as specified

    **Not participating: Belgium, France and Germany

    Cohort expansion participating countries: Spain, US, UK, Netherlands, Japan and Mexico

    **Not participating in cohort expansion: France, Germany, Korea and Taiwan

    Interventions:
    • Drug: Nivolumab
    • Drug: Ipilimumab
  • Experimental: Nivolumab plus Relatlimab Cohort

    Nivolumab intravenous infusion as specified with Relatlimab intravenous infusion as specified

    ** Not Participating: Belgium, Germany, France, Japan, Korea, Taiwan, UK, and Netherlands

    Enrollment is closed for this cohort

    Interventions:
    • Drug: Nivolumab
    • Drug: Relatlimab
  • Experimental: Nivolumab plus Daratumumab Cohort

    Nivolumab intravenous infusion as specified with Daratumumab intravenous infusion as specified

    **Not Participating: Belgium, Germany, France, Japan, Korea, Taiwan, UK, and Netherlands

    Enrollment is closed for this cohort

    Interventions:
    • Drug: Nivolumab
    • Drug: Daratumumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 14, 2020)
584
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2015)
200
Estimated Study Completion Date  ICMJE August 4, 2022
Estimated Primary Completion Date August 4, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Histopathologic confirmation of the following tumor types (please refer to protocol for full details pertaining to eligible tumor types):

    1. Merkel Cell Carcinoma
    2. Gastric or Gastro-Esophageal junction carcinoma (No longer enrolling this tumor type)
    3. Nasopharyngeal Carcinoma
    4. Squamous cell carcinoma (SCC) of the cervix, vagina, or vulva
    5. Squamous cell carcinoma of the Head and Neck
    6. Squamous cell carcinoma of the anal canal and penis
    7. Recurrent/metastatic SCC of the cervix not amenable to curative treatment with surgery and/or radiation therapy who are unsuitable for platinum-based therapy may enroll in the cervical cancer Combination B expansion cohort
  • Measurable disease by CT or MRI
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patient willing to comply to provide tumor tissue (archival or fresh biopsy specimen)
  • Men and women of age 18 or older

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases
  • Patients with active, known or suspected autoimmune disease
  • Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
  • Patients with hepatitis
  • Patients with HIV
  • Pregnant or breastfeeding women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Argentina,   Romania
 
Administrative Information
NCT Number  ICMJE NCT02488759
Other Study ID Numbers  ICMJE CA209-358
2015-000230-29 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP