NCT01928394CompletedPhase 1/2
CheckMate 032:CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 032
A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid Tumors
Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 Nov 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 83 (actual)
- First submitted
- 29 Aug 2024
- Start date
- 11 Dec 2013
- Lead sponsor
- Bristol Myers Squibb International Corporation
- Diseases
- Triple-negative breast cancer, Bladder cancer, Lung cancer, Pancreatic cancer, Metastatic breast cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT01928394
- EU CT number
- 2024-516540-25-00
- EudraCT number
- 2013-002844-10
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 83
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Subjects with active, known or suspected autoimmune disease
Other
- Active brain metastases or leptomeningeal metastases
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Completed |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.