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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002844-10-IT

Enrollment

200

Registered

2013-11-08

Start date

2013-12-18

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 14.1 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10041067 Term: Small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and un

Interventions

Product Name: Nivolumab Product Code: BMS-936558 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: NIVOLUMAB CAS Number: 946414-94-4 Current Sponsor code: BMS-936558-01 Other d

Eligibility

Sex/Gender

All

Inclusion 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 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 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.

Design outcomes

Primary

Measure	Time frame
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 Objective: • BOR (Best Overall Response) • DOR (Duration of Response) • Safety • PFS (Performance Free Survival) • 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)	—

Measure

Time frame

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 Objective: • BOR (Best Overall Response) • DOR (Duration of Response) • Safety • PFS (Performance Free Survival) • 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)

—

Secondary

Measure	Time frame
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	—

Countries

Denmark, Finland, Germany, Italy, Spain, United Kingdom, United States

Contacts

Public ContactEU Study Start-Up Unit

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026