Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma
Public ClinicalTrials.gov record NCT04609046. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I Trial of Methotrexate, Rituximab, Lenalidomide, and Nivolumab (Nivo-MR2) Induction Followed by Lenalidomide and Nivolumab Maintenance in Primary CNS Lymphoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I trial tests the safety, side effects, best dose and effectiveness of lenalidomide when added to nivolumab and the usual drugs (rituximab and methotrexate) in patients with primary central nervous system (CNS) lymphoma. Lenalidomide may stop or slow primary CNS lymphoma by blocking the growth of new blood vessels necessary for tumor growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Methotrexate is frequently combined with other chemotherapy agents to improve response. This study may help increase the understanding of lenalidomide and nivolumab use in primary CNS lymphoma treatment. In addition, it may help researchers see whether the control of CNS lymphoma can be extended by using these study drugs as maintenance (prolonged therapy) after control is achieved with the initial chemotherapy regimen (induction).
Study identification
- NCT ID
- NCT04609046
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 47 participants
Conditions and interventions
Interventions
- Bone Marrow Aspiration and Biopsy Procedure
- Computed Tomography Procedure
- Echocardiography Test Procedure
- Lenalidomide Drug
- Lumbar Puncture Procedure
- Magnetic Resonance Imaging Procedure
- Methotrexate Drug
- Nivolumab Biological
- Positron Emission Tomography Procedure
- Rituximab Biological
- Ultrasound Imaging Procedure
Procedure · Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 24, 2021 (Actual)
- Primary completion
- Apr 1, 2027 (Estimated)
- Completion
- Apr 1, 2027 (Estimated)
- Last update posted
- Sep 4, 2026
2021 – 2027
United States locations
- U.S. sites
- 56
- U.S. states
- 18
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| UCSF Medical Center-Parnassus | San Francisco | California | 94143 | — |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | 33146 | — |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | 33442 | — |
| UM Sylvester Comprehensive Cancer Center at Doral | Doral | Florida | 33166 | — |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | — |
| UM Sylvester Comprehensive Cancer Center at Kendall | Miami | Florida | 33176 | — |
| University of Miami Sylvester Comprehensive Cancer Center at Sole Mia | North Miami | Florida | 33181 | — |
| UM Sylvester Comprehensive Cancer Center at Plantation | Plantation | Florida | 33324 | — |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | Ankeny | Iowa | 50023 | — |
| Saint Anthony Regional Hospital | Carroll | Iowa | 51401 | — |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic | Clive | Iowa | 50325 | — |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | — |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic | Des Moines | Iowa | 50309 | — |
| Broadlawns Medical Center | Des Moines | Iowa | 50314 | — |
| Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | — |
| UI Health Care Mission Cancer and Blood - Laurel Clinic | Des Moines | Iowa | 50314 | — |
| Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | — |
| UI Healthcare Mission Cancer and Blood - Fort Dodge | Fort Dodge | Iowa | 50501 | — |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | — |
| UI Health Care Mission Cancer and Blood - Waukee Clinic | Waukee | Iowa | 50263 | — |
| Methodist West Hospital | West Des Moines | Iowa | 50266-7700 | — |
| LSU Health Baton Rouge-North Clinic | Baton Rouge | Louisiana | 70805 | — |
| Our Lady of the Lake Physician Group | Baton Rouge | Louisiana | 70808 | — |
| MaineHealth Maine Medical Center - Portland | Portland | Maine | 04102 | — |
| MaineHealth Maine Medical Center- Scarborough | Scarborough | Maine | 04074 | — |
| MaineHealth Cancer Care and IV Therapy - South Portland | South Portland | Maine | 04106 | — |
| Hickman Cancer Center | Adrian | Michigan | 49221 | — |
| Toledo Clinic Cancer Centers-Monroe | Monroe | Michigan | 48162 | — |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | — |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | — |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | — |
| Overlook Hospital | Summit | New Jersey | 07902 | — |
| Northwell Health/Center for Advanced Medicine | Lake Success | New York | 11042 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | — |
| NYP/Weill Cornell Medical Center | New York | New York | 10065 | — |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Toledo Clinic Cancer Centers-Toledo | Toledo | Ohio | 43623 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
| West Virginia University Healthcare | Morgantown | West Virginia | 26506 | — |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | — |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | — |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | — |
| Marshfield Medical Center - Minocqua | Minocqua | Wisconsin | 54548 | — |
| Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | 54868 | — |
| Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin | 54482 | — |
| Marshfield Medical Center - Weston | Weston | Wisconsin | 54476 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04609046, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 4, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04609046 live on ClinicalTrials.gov.