EUCTR2013-002844-10-ES
Active, not recruiting
Not Applicable
A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid Tumors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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 (\> 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.
Outcomes
Primary Outcomes
Not specified
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A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid TumorsAdvanced 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]EUCTR2013-002844-10-ITBristol-Myers Squibb International Corporation200
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A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid TumorsAdvanced 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: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10041067Term: Small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2013-002844-10-DKBristol-Myers Squibb International Corporation1,620