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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)

This study is currently recruiting participants.
Verified October 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT02488759
First Posted: July 2, 2015
Last Update Posted: October 19, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose

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
  • Cervical cancer
  • Epstein Barr Virus (EBV) positive gastric cancer
  • HPV positive and negative squamous cell cancer of the head and neck (SCCHN)
  • Merkel Cell Cancer
  • Nasopharyngeal cancer (NPC)
  • Penile cancer
  • Vaginal and vulvar cancer

Condition Intervention Phase
Various Advanced Cancer Drug: Nivolumab Drug: Ipilimumab Drug: BMS-986016 Drug: Daratumumab Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]
    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


Secondary Outcome Measures:
  • 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 [ Time Frame: Approximately 3 years ]
  • Overall survival [ Time Frame: Approximately 3 years ]
  • Duration of response [ Time Frame: Approximately 3 years ]

Estimated Enrollment: 500
Actual Study Start Date: October 8, 2015
Estimated Study Completion Date: December 31, 2019
Estimated Primary Completion Date: May 13, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neoadjuvant Cohort
Nivolumab intravenous infusion as specified
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

Drug: Nivolumab Drug: Ipilimumab
Experimental: Nivolumab plus BMS-986016 Cohort

Nivolumab intravenous infusion as specified with BMS-986016 intravenous infusion as specified

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

Drug: Nivolumab Drug: BMS-986016
Other Name: 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 and Taiwan

Drug: Nivolumab Drug: Daratumumab
Other Name: Darzalex

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
    3. Nasopharyngeal Carcinoma
    4. Squamous cell carcinoma of the cervix, vagina, or vulva
    5. Squamous cell carcinoma of the Head and Neck
    6. Squamous cell carcinoma of the anal canal and penile
  • 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
  Contacts and Locations
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
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 44 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02488759     History of Changes
Other Study ID Numbers: CA209-358
2015-000230-29 ( EudraCT Number )
First Submitted: June 30, 2015
First Posted: July 2, 2015
Last Update Posted: October 19, 2017
Last Verified: October 2017

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

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