Clinical Trial - NCT02488759

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

Recruiting

Sponsor: Bristol-Myers Squibb

Collaborators: Ono Pharmaceutical Co. Ltd

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02488759

Protocol Info

Short Description: Phase 1/2 Study of Nivolumab in Virus-Positive and Virus-Negative Solid Tumors
Long Description: Non-Comparative, Two-Cohort, Single-Arm, Open-Label, Phase 1/2 Study of Nivolumab (BMS- 936558) in Subjects with Virus-Positive and Virus-Negative Solid Tumors
MGH Status: Open
Sponsor: Bristol Myers Squibb
Disease Program: Phase I

Next Steps


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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-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
Condition Title Intervention Phase
Various Advanced Cancer Nivolumab Ipilimumab Relatlimab Daratumumab Phase 1/Phase 2
Study Type Interventional
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

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] [Designated as safety issue: ]

Objective response rate [Time Frame: 6 months after the last patient receives their first dose] [Designated as safety issue: ]

Rate of surgery delay [Time Frame: 6 months after the last patient receives their first dose] [Designated as safety issue: ]


Secondary Outcome Measures

Progression-free survival [Time Frame: Approximately 3 years] [Designated as safety issue: ]

Overall survival [Time Frame: Approximately 3 years] [Designated as safety issue: ]

Duration of response [Time Frame: Approximately 3 years] [Designated as safety issue: ]

Estimated Enrollment: 600
Study Start Date: October 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: May 2019
Arms Assigned Interventions

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

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: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: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
Drug:Daratumumab

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02488759

Locations

  • United States, Florida
    • H. Lee Moffitt Cancer Center Tampa, Florida, United States, 33612-9497
  • United States, Georgia
    • Winship Cancer Institute Atlanta, Georgia, United States, 30322
  • United States, Louisiana
    • Local Institution New Orleans, Louisiana, United States, 70121
  • United States, Maryland
    • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins Lutherville, Maryland, United States, 21093
  • United States, Massachusetts
    • Dana-Farber Cancer Institute Boston, Massachusetts, United States, 02114
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
    • Beth Israel Desc. Med Ctr Boston, Massachusetts, United States, 02215
  • United States, Michigan
    • University Of Michigan Comprehensive Cancer Center Ann Arbor, Michigan, United States, 48109
  • United States, New York
    • Memorial Sloan-Kettering Cancer Center-Breast Center New York, New York, United States, 10017
  • United States, North Carolina
    • Levine Cancer Institute Charlotte, North Carolina, United States, 28204
  • United States, Oklahoma
    • Stephenson Cancer Center Oklahoma City, Oklahoma, United States, 73104
  • United States, Oregon
    • Providence Portland Medical Center Portland, Oregon, United States, 97213
  • United States, Pennsylvania
    • UPMC Eye and Ear Institute Pittsburgh, Pennsylvania, United States, 15232
  • United States, South Dakota
    • Sanford Clinic Clinical Research Sioux Falls, South Dakota, United States, 57104-4707
  • United States, Washington
    • Seattle Cancer Care Alliance Seattle, Washington, United States, 98109
  • Argentina, Buenos Aires
    • Local Institution Capital Federal, Buenos Aires, Argentina, 1426
  • Belgium,
    • Local Institution Brussels, , Belgium, 1000
    • Local Institution Brussels, , Belgium, 1090
    • Local Institution Bruxelles, , Belgium, 1200
  • France,
    • Local Institution Marseille Cedex 9, , France, 13273
    • Local Institution Paris, , France, 75475
    • Centre Claudius Regaud Toulouse Cedex 9, , France, 31059
    • Institut Gustave Roussy Vlllejuif, , France, 94800
  • Germany,
    • Local Institution Essen, , Germany, 45147
    • Local Institution Heidelberg, , Germany, 69120
    • Local Institution Heilbronn, , Germany, 74078
    • Local Institution Wuerzburg, , Germany, 97080
  • Japan, Chiba
    • Local Institution Kashiwa-shi, Chiba, Japan, 2778577
  • Japan, Tokyo
    • Local Institution Chuo-ku, Tokyo, Japan, 1040045
    • Local Institution Koto-ku, Tokyo, Japan, 135-8550
  • Korea, Republic of,
    • Local Institution Seoul, , Korea, Republic of, 110-774
  • Mexico, Distrito Federal
    • COI Centro Oncologico Internacional S.A.P.I. de C.V. Ciudad de Mexico, Distrito Federal, Mexico, 04700
  • Mexico, Oaxaca
    • Local Institution Oaxaca de Juarez, Oaxaca, Mexico, 68040
  • Mexico, Yucatan
    • Centro de Atencion e Investigacion Clinica en Oncologia SCP Merida, Yucatan, Mexico, 97138
  • Netherlands,
    • Local Institution Amsterdam, , Netherlands, 1066 CX
    • Local Institution Utrecht, , Netherlands, 3584 CX
  • Romania,
    • Local Institution Craiova, , Romania, 200347
  • Spain,
    • H. Univ. Vall dHebron Barcelona, , Spain, 08035
    • Hospital Madrid Norte Sanchinarro Madrid, , Spain, 28050
    • Clinica Universidad de Navarra Navarra, , Spain, 31008
  • Taiwan,
    • Local Institution Tainan, , Taiwan, 70403
    • Local Institution Taipei, , Taiwan, 10002
  • United Kingdom, Lanarkshire
    • Local Institution Glasgow, Lanarkshire, United Kingdom, G12 OYN
  • United Kingdom, WEST Midlands
    • Local Institution Birmingham, WEST Midlands, United Kingdom, B15 2TH
  • United Kingdom,
    • Local Institution London, , United Kingdom, W1T 7HA

Sponsors and Collaborators

Bristol-Myers Squibb

Ono Pharmaceutical Co. Ltd

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02488759
Other Study ID Numbers: 2015-000230-29
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Nivolumab

Ipilimumab

Daratumumab

Antibodies, Monoclonal

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on May 16, 2019