A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors
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| ClinicalTrials.gov Identifier: NCT01928394 |
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Recruitment Status :
Active, not recruiting
First Posted : August 23, 2013
Results First Posted : March 24, 2020
Last Update Posted : April 18, 2023
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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), small cell lung cancer (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combination of nivolumab with ipilimumab and cobimetinib is also investigated in PC.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced or Metastatic Solid Tumors | Biological: Nivolumab Biological: Ipilimumab Drug: Cobimetinib | Phase 1 Phase 2 |
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1163 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors |
| Actual Study Start Date : | October 24, 2013 |
| Actual Primary Completion Date : | February 5, 2019 |
| Estimated Study Completion Date : | December 31, 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm N - Nivolumab
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
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Biological: Nivolumab
Other Names:
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Experimental: Arm N-I, Level 1: Nivolumab+Ipilimumab
Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 1 mg/kg solution every 3 weeks for 4 doses followed by Nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
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Biological: Nivolumab
Other Names:
Biological: Ipilimumab Other Names:
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Experimental: Arm N-I, Level 2: Nivolumab+Ipilimumab
Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
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Biological: Nivolumab
Other Names:
Biological: Ipilimumab Other Names:
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Experimental: Arm N-I, Level 2b: Nivolumab+Ipilimumab
Nivolumab 3 mg/kg solution intravenously plus Ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
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Biological: Nivolumab
Other Names:
Biological: Ipilimumab Other Names:
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Experimental: Arm N-I, Level 2c: Nivolumab+Ipilimumab
Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
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Biological: Nivolumab
Other Names:
Biological: Ipilimumab Other Names:
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Experimental: Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib
Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks and cobimetinib 60mg once daily 21days on/7 days off until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
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Biological: Nivolumab
Other Names:
Biological: Ipilimumab Other Names:
Drug: Cobimetinib Other Name: Cotellic |
Primary Outcome Measures :
- Objective Response Rate ( ORR ) [ Time Frame: 60 months ]The number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Subjects with histologically or cytologically confirmed locally advanced or metastatic disease of the following tumor types:
- Triple Negative Breast Cancer
- Gastric Cancer
- Pancreatic Cancer
- Small Cell Lung Cancer
- Bladder Cancer
- Ovarian Cancer
- Subjects must have measurable disease
- Eastern Cooperative Oncology Group (ECOG) of 0 or 1
- Adequate hematological and organ function as confirmed by laboratory values
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928394
Locations
Show 38 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Study Documents (Full-Text)
Documents provided by Bristol-Myers Squibb:
Documents provided by Bristol-Myers Squibb:
Study Protocol [PDF] October 3, 2019
Statistical Analysis Plan [PDF] November 12, 2017
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01928394 |
| Other Study ID Numbers: |
CA209-032 2013-002844-10 ( EudraCT Number ) |
| First Posted: | August 23, 2013 Key Record Dates |
| Results First Posted: | March 24, 2020 |
| Last Update Posted: | April 18, 2023 |
| Last Verified: | April 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Neoplasms Nivolumab Ipilimumab Antineoplastic Agents, Immunological |
Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |