A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid Tumors
- 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). 5) Bladder Cancer (BC) 6) Ovarian Cancer (OC)MedDRA version: 21.1 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1 Level: PT Classification code 10041067 Term: Small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0 Level: LLT Classification code 10033604 Term: Pancreatic cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-002844-10-GB
- 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
- Not specified
- Target Recruitment
- 1620
- 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
- Ovarian Carcinoma
- Bladder 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 810
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 810
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 <br> Secondary Objective: • BOR (Best Overall Response)<br> • DOR (Duration of Response)<br> • Safety<br> • PFS (Performance Free Survival)<br> • OS (Overall Survival)<br> ;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 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), and small cell lung cancer (SCLC), Bladder Cancer (BC) and Ovarian Cancer (OC).
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): 1/ Rate of treatment-related adverse events (AEs) leading to drug discontinuations during the first 12 weeks of treatment<br> 2/ Progression Free Survival (PFS)<br> 3/ Overall Survival (OS)<br> ;<br> Timepoint(s) of evaluation of this end point: 1/ Up to Week 12 of treatment<br> 2/ From treatment assignment in IVRS to the date of the first documented tumor progression,<br> 3/ Time between the date of treatment assignment in IVRS and the date of death due to any cause.<br>