Condition or disease | Intervention/treatment | Phase |
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Brain and Nervous System Eye and Orbit | Drug: Nivolumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1B Trial Nivolumab Consolidation Following Completion of High-Dose Methotrexate Containing Induction Chemotherapy in Older (≥ 65) Patients With Primary CNS Lymphoma |
Actual Study Start Date : | July 25, 2019 |
Estimated Primary Completion Date : | May 2025 |
Estimated Study Completion Date : | May 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Stage 1
Safety Run-In
|
Drug: Nivolumab
HD-MTX containing induction chemotherapy (per standard of care) followed by Nivolumab consolidation.
|
Experimental: Stage 2
Expansion Cohort
|
Drug: Nivolumab
HD-MTX containing induction chemotherapy (per standard of care) followed by Nivolumab consolidation.
|
Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must meet all of the following criteria to participate in this study:
Demonstrate adequate organ function as defined below (all screening labs to be obtained within 14 days prior to day 1 of treatment):
Exclusion Criteria:
Subjects must not meet any of the following criteria:
Contact: Kelly Bumgarner, RN | 704-403-2520 | Kelly.Bumgarner@atriumhealth.org |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Brookline, Massachusetts, United States, 02215 | |
Contact: Meghan Cifrino, RN 617-632-2166 Meghan_Cifrino@DFCI.HARVARD.EDU | |
Principal Investigator: Lakshmi Nayak, MD | |
United States, North Carolina | |
UNC Hospitals, The University of North Carolina at Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27514 | |
Contact: Kelly Hoye 919-843-9819 kelly_hoye@med.unc.edu | |
Principal Investigator: Christopher Dittus, MD | |
Levine Cancer Institute | Recruiting |
Charlotte, North Carolina, United States, 28204 | |
Contact: Kelly Bumgarner, RN 704-403-2520 Kelly.Bumgarner@atriumhealth.org | |
Principal Investigator: Steven Park, MD | |
United States, Texas | |
The University of Texas - MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Anuoluwa Ogunlere, RN 713-563-1630 AOOgunlere@mdanderson.org | |
Principal Investigator: Raphael Steiner, MD |
Principal Investigator: | Steven Park, MD | Atrium Health |
Tracking Information | |||||
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First Submitted Date ICMJE | July 12, 2019 | ||||
First Posted Date ICMJE | July 17, 2019 | ||||
Last Update Posted Date | May 7, 2021 | ||||
Actual Study Start Date ICMJE | July 25, 2019 | ||||
Estimated Primary Completion Date | May 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Nivolumab Consolidation in Older (≥ 65) Patients With Primary CNS Lymphoma | ||||
Official Title ICMJE | A Phase 1B Trial Nivolumab Consolidation Following Completion of High-Dose Methotrexate Containing Induction Chemotherapy in Older (≥ 65) Patients With Primary CNS Lymphoma | ||||
Brief Summary | The primary objective of Stage 1 is to evaluate the safety of nivolumab consolidation after completion of HD-MTX containing induction chemotherapy in older subjects with PCNSL in terms of a tolerated dose (based on dose-limiting toxicities) for the expansion phase of the study (Stage 2).The primary objective of Stage 2 is to evaluate the efficacy of nivolumab consolidation after completion of HD-MTX containing induction chemotherapy in terms of the 2-year progression-free survival rate and compare to relevant historical controls | ||||
Detailed Description | This is a 2-stage phase 1B study of nivolumab consolidation following completion of HD-MTX containing induction chemotherapy in older (≥ 65 years old) patients with previously untreated primary CNS lymphoma. Stage 1 is designed to evaluate the safety of nivolumab consolidation. We plan to use 3+3 design and start at the FDA approved single agent dose of nivolumab 480 mg intravenously every 4 weeks. Stage 2 is designed to evaluate the safety as well as efficacy of nivolumab consolidation after HD-MTX containing induction chemotherapy in an expansion cohort. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Nivolumab
HD-MTX containing induction chemotherapy (per standard of care) followed by Nivolumab consolidation.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
20 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | May 2025 | ||||
Estimated Primary Completion Date | May 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Subjects must meet all of the following criteria to participate in this study:
Exclusion Criteria: Subjects must not meet any of the following criteria:
|
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Sex/Gender ICMJE |
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Ages ICMJE | 65 Years and older (Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04022980 | ||||
Other Study ID Numbers ICMJE | LCI-HEM-PCNSL-RMPV-001 00036735 ( Other Identifier: Advarra IRB ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Steven Park, MD, Atrium Health | ||||
Study Sponsor ICMJE | Steven Park, MD | ||||
Collaborators ICMJE | Bristol-Myers Squibb | ||||
Investigators ICMJE |
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PRS Account | Atrium Health | ||||
Verification Date | May 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |