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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Various Advanced Cancer

Treatments: Drug: Relatlimab; Drug: Ipilimumab; Drug: Nivolumab; Drug: Daratumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02488759

CA209-358

2015-000230-29 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 578 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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578 participants in 5 patient groups

Neoadjuvant Cohort

Experimental group

Description:

Nivolumab intravenous infusion as specified \*\*Not participating: Japan, Korea, and Taiwan

Treatment:

Drug: Nivolumab

Metastatic Monotherapy Cohort

Experimental group

Description:

Nivolumab intravenous infusion as specified

Treatment:

Drug: Nivolumab

Nivolumab plus Ipilimumab Cohort

Experimental group

Description:

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

Treatment:

Drug: Nivolumab

Drug: Ipilimumab

Nivolumab plus Relatlimab Cohort

Experimental group

Description:

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

Treatment:

Drug: Nivolumab

Drug: Relatlimab

Nivolumab plus Daratumumab Cohort

Experimental group

Description:

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

Treatment:

Drug: Nivolumab

Drug: Daratumumab