A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid Tumors

Phase 1

Conditions: Advanced or metastatic solid tumors:1) Triple Negative Breast Cancer (TNBC)2) Gastric Cancer (GC)3) Pancreatic Cancer (PC)4) Small Cell Lung Cancer (SCLC).
MedDRA version: 14.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: PTClassification code 10041067Term: Small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-002844-10-IT

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 200

Inclusion Criteria

• Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:
? Triple Negative Breast Cancer
? Gastric Cancer
? Pancreatic Cancer
? Small Cell Lung Cancer
• Subjects must have measurable disease
• ECOG of 0 or 1.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Exclusion
• Active brain metastases or leptomeningeal metastases.
• Subjects with active, known or suspected autoimmune disease.
• Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment.
• Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, including ipilimumab; or other medicines specifically targeting T cell is also prohibited.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: • BOR (Best Overall Response)<br>• DOR (Duration of Response)<br>• Safety<br>• PFS (Performance Free Survival)<br>• OS (Overall Survival);Primary end point(s): Objective response rate (ORR) in all assigned subjects as determined by the investigators. ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of assigned subjects;Timepoint(s) of evaluation of this end point: Up until time of first documented tumor progression or death (approximately up to 17 months);Main Objective: To investigate the safety and efficacy of nivolumab as a single agent or in combination with ipilimumab in 4 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), and small cell lung cancer (SCLC).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Rate of treatment-related adverse events (AEs) leading to drug discontinuations during the first 12 weeks of treatment;Timepoint(s) of evaluation of this end point: Up to Week 12 of treatment

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