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Clinical Trials/2024-516540-25-00
2024-516540-25-00CompletedPhase 2

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

Bristol Myers Squibb International Corporation2 sites in 1 country83 target enrollmentStarted: September 12, 2024Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
83
Locations
2
Primary Endpoint
Objective response rate (ORR) in all assigned subjects as determined by the investigators. ORR is defined as the number of subjects with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of assigned subjects
Study OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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).

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types: Triple Negative Breast Cancer
  • •Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:Gastric Cancer
  • •Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:Pancreatic Cancer
  • •Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:Small Cell Lung Cancer
  • •Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:Ovarian Carcinoma
  • •Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:Bladder Cancer
  • •Subjects must have measurable disease
  • •ECOG of 0 or 1.

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 costimulation 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

Objective response rate (ORR) in all assigned subjects as determined by the investigators. ORR is defined as the number of subjects with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of assigned subjects

Objective response rate (ORR) in all assigned subjects as determined by the investigators. ORR is defined as the number of subjects with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of assigned subjects

Secondary Outcomes

  • Rate of treatment-related adverse events (AEs) leading to drug discontinuations during the first 12 weeks of treatment
  • Progression Free Survival (PFS)
  • Overall Survival (OS)

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

GSM-CT

Scientific

Bristol Myers Squibb International Corporation

Study Sites (2)

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