A study to investigate the safety and efficacy of nivolumab in virus-associated tumors

Phase 1

• Conditions: Virus-associated tumors; MedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10008229Term: Cervical cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10061306Term: Nasopharyngeal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10046885Term: Vaginal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10047777Term: Vulvar cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10064025Term: Merkel cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000230-29-DE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-28
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

-Histopathologic confirmation of the following tumor types (please refer to protocol for full details pertaining to eligible tumor types):
• Merkel Cell Carcinoma
• Gastric or Gastro-Esophageal junction carcinoma
• Nasopharyngeal Carcinoma
• Squamous cell carcinoma of the cervix, vagina, or vulva
• Squamous cell carcinoma of the Head and Neck
-Measurable disease by CT or MRI
-Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
-Subject willing to comply to provide tumor tissue (archival or fresh biopsy specimen)
-Men and women of age 18 or older.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 286
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 714

Exclusion Criteria

-Active brain metastases or leptomeningeal metastases
-Subjects with active, known or suspected autoimmune disease
-Subjects with a condition requiring systemic treatment with either corticosteroids
-Subjects with hepatitis;Subjects with HIV
-Pregnant or breastfeeding women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified