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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)

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ClinicalTrials.gov Identifier: NCT02488759
Recruitment Status : Recruiting
First Posted : July 2, 2015
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Various Advanced Cancer Drug: Nivolumab Drug: Ipilimumab Drug: Relatlimab Drug: Daratumumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 8, 2015
Estimated Primary Completion Date : May 12, 2022
Estimated Study Completion Date : May 13, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neoadjuvant Cohort

Nivolumab intravenous infusion as specified

**Not participating: Japan, Korea, and Taiwan

Drug: Nivolumab
Experimental: Metastatic Monotherapy Cohort
Nivolumab intravenous infusion as specified
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

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

Drug: Nivolumab
Drug: Relatlimab
Other Names:
  • BMS-986016
  • Anti-LAG 3

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

Drug: Nivolumab
Drug: Daratumumab
Other Name: Darzalex




Primary Outcome Measures :
  1. 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 ]
  2. Objective response rate [ Time Frame: 6 months after the last patient receives their first dose ]
  3. Rate of surgery delay [ Time Frame: 6 months after the last patient receives their first dose ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Approximately 3 years ]
  2. Overall survival [ Time Frame: Approximately 3 years ]
  3. Duration of response [ Time Frame: Approximately 3 years ]


Information from the National Library of Medicine

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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:

  • 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

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): NCT02488759


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 45 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02488759     History of Changes
Other Study ID Numbers: CA209-358
2015-000230-29 ( EudraCT Number )
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nivolumab
Ipilimumab
Daratumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents