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A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Hematologic Malignancies (MK-2140-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03833180
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
VelosBio Inc.

Brief Summary:
The purpose of this study is to evaluate the safety, pharmacokinetics, immunogenicity, and efficacy of zilovertamab vedotin given intravenously (IV) across a range of dose levels in participants with previously treated hematological cancers including acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), Burkitt lymphoma (BL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), Richter transformation lymphoma (RTL), and T-cell non-Hodgkin lymphoma (NHL).

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Follicular Lymphoma Marginal Zone Lymphoma Diffuse Large B-cell Lymphoma Richter Transformation Lymphoma Burkitt Lymphoma Lymphoplasmacytoid Lymphoma T-cell Non-Hodgkin Lymphoma Acute Lymphoid Leukemia Acute Myeloid Leukemia Waldenstrom Macroglobulinemia Drug: Zilovertamab vedotin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Cohorts of 3 to 6 subjects will be sequentially enrolled at progressively higher dose levels within each dose schedule of zilovertamab vedotin using a 3+3 dose-escalation design.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation and Cohort-Expansion Study of VLS-101 in Subjects With Hematological Malignancies
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : October 1, 2023


Arm Intervention/treatment
Experimental: Zilovertamab vedotin Schedule 1: Q1/3W
Participants will be administered escalating doses of zilovertamab vedotin at 0.50, 1.00, 1.50, 2.25, 2.50, 2.75, and 3.00 mg/kg IV on Day 1 of repeated 21-day cycles (Q1/3W).
Drug: Zilovertamab vedotin
Zilovertamab vedotin administered via IV infusion per Schedule 1, 2, or 3 according to participant allocation.
Other Names:
  • VLS-101
  • MK-2140

Experimental: Zilovertamab vedotin Schedule 2: Q2/3W
Participants will be administered escalating doses of zilovertamab vedotin at 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, and 2.25 mg/kg IV on Day 1 and 8 of repeated 21-day cycles (Q2/3W).
Drug: Zilovertamab vedotin
Zilovertamab vedotin administered via IV infusion per Schedule 1, 2, or 3 according to participant allocation.
Other Names:
  • VLS-101
  • MK-2140

Experimental: Zilovertamab vedotin Schedule 3: Q3/4W
Participants will be administered escalating doses of zilovertamab vedotin at 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, and 2.25 mg/kg IV on Day 1, 8, and 15 of repeated 21-day cycles (Q3/4W).
Drug: Zilovertamab vedotin
Zilovertamab vedotin administered via IV infusion per Schedule 1, 2, or 3 according to participant allocation.
Other Names:
  • VLS-101
  • MK-2140




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of zilovertamab vedotin [ Time Frame: Cycle 1 (Up to 21 Days) ]
    Participants will receive zilovertamab vedotin according to Schedule 1, 2, or 3. The MTD will be determined by the number of participants who experience a dose limiting toxicity (DLT). The MTD will be defined as the highest tested dose level at which ≥6 participants have been treated and which is associated with a Cycle 1 DLT in ≤17% of the participants.

  2. Recommended Dosing Regimen (RDR) [ Time Frame: Cycle 1 (Up to 21 Days) ]
    Selection of the RDR will be based on consideration of short- and long-term safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The RDR may be the MTD or may be a lower dose within the tolerable dose range.


Secondary Outcome Measures :
  1. Average number of zilovertamab vedotin infusions administered [ Time Frame: Up to 5 months ]
    Zilovertamab vedotin drug administration will be assessed by prescribing records and the average number of zilovertamab vedotin infusions administered will be determined.

  2. Number of participants with a treatment-emergent adverse event (TEAE) [ Time Frame: Up to approximately 3.5 years ]
    An AE is any untoward medical occurrence in a participant administered a medicinal product; the event does not necessarily have a causal relationship with study drug administration or usage. Laboratory abnormalities, vital sign/oxygen saturation abnormalities, and adverse electrocardiogram (ECG) findings will also be recorded as AEs. A TEAE is defined as an AE that occurs or worsens in the period from the first dose of study drug administration to 30 days after the final dose of study drug administration. The number of participants with a TEAE will be reported for each arm.

  3. Number of participants with a DLT [ Time Frame: Cycle 1 (Up to 21 Days) ]
    A DLT is defined as a protocol pre-specified TEAE that occurs in Cycle 1 of zilovertamab vedotin therapy and is considered drug-related. Failure to recover to baseline by ≥21 days from the last dose of study drug in the current cycle due to a drug-related TEAE is also considered a DLT. The number of participants with a DLT will be reported for each arm.

  4. Number of participants with a serious adverse event (SAE) [ Time Frame: Up to approximately 3.5 years ]
    An SAE is defined as an untoward medical occurrence that results in any of the following outcomes: death, life-threatening situation, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or other medically significant event.

  5. Number of participants with an adverse event of special interest (AESI) [ Time Frame: Up to approximately 3.5 years ]
    Prespecified AESIs for this study will include: Grade ≥3 infusion reactions, tumor lysis syndrome (TLS) of any grade, and Grade ≥3 peripheral neuropathy. The number of participants with an AESI will be reported for each arm.

  6. Number of participants that discontinue study treatment due to an AE [ Time Frame: Up to approximately 3.5 years ]
    An AE is any untoward medical occurrence in a participant administered a medicinal product; the event does not necessarily have a causal relationship with study drug administration or usage. The number of participants that discontinue study treatment due to an AE will be reported for each arm.

  7. Number of participants that use supportive care or concomitant medications [ Time Frame: Up to approximately 3.5 years ]
    The number of participants that use supportive care or concomitant medications will be reported for each arm.

  8. Plasma concentration of zilovertamab vedotin [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Plasma concentration of zilovertamab vedotin will be reported for each arm.

  9. Plasma concentration of total UC-961 antibody [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Plasma concentration of total UC-961 antibody will be reported for each arm.

  10. Plasma concentration of monomethyl auristatin E (MMAE) [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Plasma concentration of MMAE will be reported for each arm.

  11. Maximum plasma concentration (Cmax) of zilovertamab vedotin [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine Cmax of zilovertamab vedotin.

  12. Time to maximum plasma concentration (Tmax) of zilovertamab vedotin [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine Tmax of zilovertamab vedotin.

  13. Area under the plasma concentration time curve (AUC) of zilovertamab vedotin [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine AUC of zilovertamab vedotin.

  14. Volume of distribution (Vd) of zilovertamab vedotin [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine Vd of zilovertamab vedotin.

  15. Clearance (CL) of zilovertamab vedotin [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine CL of zilovertamab vedotin.

  16. Apparent terminal half-life (t½) of plasma concentration of zilovertamab vedotin [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine t1/2 of plasma concentration of zilovertamab vedotin.

  17. Cmax of total UC-961 antibody [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine Cmax of total UC-961 antibody.

  18. Tmax of total UC-961 antibody [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine Tmax of total UC-961 antibody.

  19. AUC of total UC-961 antibody [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine AUC of total UC-961 antibody.

  20. Vd of total UC-961 antibody [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine Vd of total UC-961 antibody.

  21. CL of total UC-961 antibody [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine CL of total UC-961 antibody.

  22. t1/2 of plasma concentration of total UC-961 antibody [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine t1/2 of plasma concentration of total UC-961 antibody.

  23. Cmax of MMAE [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine Cmax of MMAE.

  24. Tmax of MMAE [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine Tmax of MMAE.

  25. AUC of MMAE [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine AUC of MMAE.

  26. Vd of MMAE [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine Vd of MMAE.

  27. CL of MMAE [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine CL of MMAE.

  28. t1/2 of plasma concentration of MMAE [ Time Frame: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion ]
    Blood samples collected predose and at multiple timepoints postdose will be used to determine t1/2 of plasma concentration of MMAE.

  29. Number of participants with zilovertamab vedotin-reactive antibodies [ Time Frame: Day 1 of Cycles 1 through end of therapy (up to approximately 3.5 years): predose and end of infusion (up to ~30 minutes) ]
    Number of participants with zilovertamab vedotin-reactive antibodies will be assessed.

  30. Overall Response (OR) [ Time Frame: Up to approximately 3.5 years ]
    OR will be defined by achievement of the following outcomes as indicated by disease type: CLL/SLL: Complete response (CR: disappearance of detectable disease per Cheson 2012 criteria), CR with incomplete blood count recovery (CRi: CR with ≥1 additional change in absolute neutrophil count, platelet count, or hemoglobin), partial response (PR: no evidence of new disease per Cheson 2012 criteria), or PR with lymphocytosis (PR except lack of decrease in peripheral blood absolute lymphocyte count); NHL: CR (disappearance of all detectable disease per Cheson 2014 criteria) or PR (≥50% decrease in the sum of the product of diameters of the index nodal and extranodal lesions); LPL/WM: CR, very good PR (CR with ≥90% decrease in M protein), PR, or minor response (criteria for PR or stable disease met per Cheson 2014); ALL: (CR, CRi, unconfirmed CR, or PR per National Comprehensive Cancer Network criteria); AML (CR, CRi, morphologic leukemia-free state [MLFS], or PR per Cheson 2003 criteria).

  31. Complete Response without measurable residual disease (CRMRD-) [ Time Frame: Up to approximately 3.5 years ]
    CRMRD- is defined as the achievement of ≤1 × 10^-4 malignant cells in bone marrow (as assessed by flow cytometry) in a participant who meets all other criteria for CR.

  32. Percent change from baseline in tumor dimension [ Time Frame: Up to approximately 3.5 years ]
    Percent change in tumor dimensions is defined as the percent change from baseline in the sum of the products of the diameters (SPD) of index lesions.

  33. Time to Response (TTR) [ Time Frame: Up to approximately 3.5 years ]
    TTR is defined as the interval from the start of study therapy to the first documentation of an objective response.

  34. Duration of Response (DOR) [ Time Frame: Up to approximately 3.5 years ]
    DOR is defined as the interval from the first documentation of objective response to the earlier of the first documentation of disease progression/relapse or death from any cause.

  35. Progression free survival (PFS) [ Time Frame: Up to approximately 3.5 years ]
    PFS is defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression/relapse or death from any cause.

  36. Time to Treatment Failure (TTF) [ Time Frame: Up to approximately 3.5 years ]
    TTF failure is defined as the interval from start of study therapy to the earliest of the first documentation of disease progression/relapse, treatment failure (for participants with ALL or AML), the permanent cessation of study drug due to an AE, or death from any cause.

  37. Overall Survival (OS) [ Time Frame: Up to approximately 3.5 years ]
    OS is defined as the interval from the start of study therapy to death from any cause.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Inclusion Criteria:

  • Men or women of age ≥18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Histological diagnosis of CLL/SLL, MCL, FL, MZL, DLBCL, RTL, BL, LPL/WM, T-cell NHL, ALL, or AML as documented in medical records.
  • Hematological cancer has been previously treated and has progressed during or relapsed after prior systemic therapy.
  • Hematological cancer is unlikely to be responsive to established therapies known to provide clinical benefit or the study candidate has developed an intolerance to established therapies known to provide clinical benefit.
  • Presence of measurable cancer including CLL/SLL, MCL, FL, MZL, DLBCL, RTL, BL, LPL/WM, T-cell NHL, ALL, and AML.
  • Current medical need for therapy due to disease-related symptoms or complications, cytopenias, lymphadenopathy, organomegaly, extranodal organ involvement, or progressive disease.
  • Availability of pretreatment tumor tissue.
  • Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥1 week before the start of study therapy.
  • All acute toxic effects of any prior antitumor therapy (not including hydroxyurea, cytarabine, and/or cyclophosphamide used in subjects with acute leukemia) resolved to ≤Grade 1 before the start of study therapy (with the exception of alopecia [Grade 1 or 2 permitted] or selected laboratory parameters [Grade 1 or Grade 2 permitted with exceptions.
  • Adequate bone marrow function.
  • Adequate hepatic profile.
  • Adequate renal function.
  • Adequate coagulation profile.
  • Negative antiviral serology.
  • For female participants of childbearing potential, a negative serum pregnancy test.
  • For both male and female participants, willingness to use protocol-recommended method of contraception from the start of the screening period until ≥6 months after the final dose of study therapy.
  • Willingness and ability of the participant to comply with study activities.
  • Evidence of a personally signed informed consent document.

Exclusion Criteria:

  • Presence of malignancy involving the central nervous system.
  • Presence of another cancer with disease manifestations or therapy that could adversely affect participant safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results.
  • Significant cardiovascular disease within 3 months prior to start of study therapy.
  • Significant screening electrocardiogram (ECG) abnormalities.
  • Uncontrolled ongoing systemic bacterial, fungal, or viral infection.
  • Known diagnosis of liver cirrhosis.
  • Pregnancy or breastfeeding.
  • Candidacy for hematopoietic stem cell transplantation (HSCT) or chimeric antigen receptor (CAR)-T-cell therapy with access to HSCT or CAR-T cells and a willingness to undergo such therapy.
  • In participants with prior HSCT, evidence of graft-versus-host disease (GVHD) with Grade ≥2 serum bilirubin, Grade ≥3 skin involvement, or Grade ≥3 diarrhea.
  • Prior solid organ transplantation.
  • Major surgery within 4 weeks before the start of study therapy.
  • Prior therapy with a receptor tyrosine kinase-like orphan receptor 1 (ROR1)-directed therapy or with an MMAE-containing drug.
  • Ongoing immunosuppressive therapy other than corticosteroids.
  • Use of a strong inhibitor or inducer of cytochrome P450 (CYP) 3A4.
  • Use within 7 days prior to the start of study therapy of a drug known to prolong the QT interval.
  • Concurrent participation in another therapeutic or imaging clinical trial.
  • Presence of a medical condition that (in the judgement of the investigator) interferes with the ability of the participant to participate in the study.

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): NCT03833180


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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United States, California
City of Hope ( Site 0010) Recruiting
Duarte, California, United States, 91010
Contact: Study Coordinator    626-256-4673 x80478      
University of California - San Diego ( Site 0003) Recruiting
La Jolla, California, United States, 92093-0698
Contact: Study Coordinator    858-534-5201      
UCLA Hematology & Oncology ( Site 0007) Recruiting
Los Angeles, California, United States, 90095
Contact: Study Coordinator    310-633-8400 x16112      
United States, Nebraska
University of Nebraska Medical Center ( Site 0006) Recruiting
Omaha, Nebraska, United States, 68198-5331
Contact: Study Coordinator    402-559-9053      
United States, New York
Northwell Health ( Site 0009) Recruiting
New Hyde Park, New York, United States, 11042
Contact: Study Coordinator    718-470-4046      
Weill Cornell Medical College ( Site 0005) Recruiting
New York, New York, United States, 10021
Contact: Study Coordinator    212-746-6738      
University of Rochester ( Site 0008) Recruiting
Rochester, New York, United States, 14642
Contact: Study Coordinator    585-275-5825      
United States, Oregon
Oregon Health & Science University ( Site 0004) Recruiting
Portland, Oregon, United States, 97239
Contact: Study Coordinator    503-494-9324      
United States, Texas
MD Anderson Cancer Center ( Site 0001) Recruiting
Houston, Texas, United States, 77030
Contact: Study Coordinator    713-745-2714      
MD Anderson Cancer Center ( Site 0011) Recruiting
Houston, Texas, United States, 77030
Contact: Study Coordinator    713-792-7430      
United States, Virginia
University of Virginia Cancer Center ( Site 0012) Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Study Coordinator    434-243-2649      
United States, Washington
Swedish Medical Center ( Site 0002) Recruiting
Seattle, Washington, United States, 98104
Contact: Study Coordinator    206-215-2245      
Sponsors and Collaborators
VelosBio Inc.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: VelosBio Inc.
ClinicalTrials.gov Identifier: NCT03833180    
Other Study ID Numbers: 2140-001
VLS-101-0001 ( Other Identifier: VelosBio )
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VelosBio Inc.:
Lymphoma
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Follicular
Lymphoma, Mantle-Cell
Burkitt Lymphoma
Lymphoma, Lymphoplasmacytoid
Waldenström Macroglobulinemia
Lymphoma, T-cell
Leukemia, Lymphoid, Acute
Leukemia, Myeloid, Acute
Additional relevant MeSH terms:
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Burkitt Lymphoma
Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell
Waldenstrom Macroglobulinemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Lymphoma, B-Cell
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Tumor Virus Infections
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias