A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma

NCT05283720
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Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
264
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Lead sponsor
Genmab
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Start date
2022-06-14
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Number of sites
76
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Summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 496 adult participants with NHL will be enrolled in 100 sites globally. In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28 day, 21 day, or 56 day cycles dependent on the arm in combination with the anti-neoplastic agents described below: 1: Oral lenalidomide in participants (PPTS) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in PPTS with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in PPTS with newly diagnosed treatment-naïve DLBCL, or completion of treatment in 3B; 4: Oral CC-99282 in PPTS with R/R DLBCL; 5: Oral CC-99282 in PPTS with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in PPTS with R/R mantle cell lymphoma (MCL). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
clinicaltrials.gov
Short title
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
clinicaltrials.gov
Official title
Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2032-11-01
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First posted
2022-03-17
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Registry last updated
2026-07-07
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Primary completion date
2032-11-01
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Start date
2022-06-14
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Actual participants
264
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Participants
264
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Participant count basis
Actual
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Protocol amendments
9
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Number of sites
76
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Genmab
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05283720
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ClinicalTrials.gov ID
NCT05283720
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of Participants with Dose-Limiting Toxicities (DLT)

    Timeframe: Up to Approximately 5 Years

    DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

  1. Best Overall Response (BOR) per Investigator

    Timeframe: Up to Approximately 5 Years

    BOR is defined as the percentage of participants who achieved best overall response of CR or PR by Lugano 2014 criteria as assessed by the investigator.

  2. Duration of response (DOR) per Investigator

    Timeframe: Up to Approximately 5 Years

    DOR is defined for participants who achieved best overall response of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by the investigator, or death from any cause.

  3. Number of Participants with Progression-free survival (PFS)

    Timeframe: Up to Approximately 5 Years

    PFS is defined as the time in months from the first dose of study drug to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.

  4. Percentage of Participants with Complete Response (CR)

    Timeframe: Up to Approximately 5 Years

    CR is defined as the percentage of participantswho achieved best overall response of CR determined by Lugano 2014 criteria as assessed by investigator.

  5. Time-to-response (TTR)

    Timeframe: Up to Approximately 5 Years

    TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by investigator.

  6. Time to Next Antilymphoma Therapy (TTNT)

    Timeframe: Up to Approximately 5 Years

    Time to next antilymphoma therapy.

  7. Rate of Minimal Residual Disease (MRD) Negativity

    Timeframe: Up to Approximately 5 Years

    MRD is defined as the percentage of participants with assessment of the minimal residual disease.

  8. Overall Survival (OS)

    Timeframe: Up to Approximately 5 Years

    (OS) is defined as the time in months from first dose of epcoritamab to death from any cause.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Diagnosis of:

    -- Diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma (FL) or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report:

    • DLBCL, not otherwise specified (NOS).
    • High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per WHO 2016 ("double-hit" or "triple-hit") Note: High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible.
    • Follicular lymphoma (FL) Grade 3B. OR

  • FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR

  • Mantle cell lymphoma (MCL) with histologically confirmed CD20+ disease at most recent representative tumor biopsy according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR).

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2, except for Arm 6A where ECOG performance status must be 0-1.

  • Must have 1 or more measurable disease sites:

    • A positron emission tomography (PET) /computed tomography (CT) scan demonstrating PET-positive lesion(s) AND
    • At least 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or magnetic resonance imaging (MRI).

  • Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20.
  • Toxicities from prior anticancer therapy that have not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia. Other eligibility criteria (e.g., laboratory, cardiac criteria) must also be met.
Sources for eligibility
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  • The University of Arizona Cancer Center - North Campus /ID# 242219Tucson, United States
  • Yale University School of Medicine /ID# 242089New Haven, United States
  • Christiana Care Health Service /ID# 242301Newark, United States
  • Tampa General Hospital /ID# 246748Tampa, United States
  • Winship Cancer Institute of Emory University /ID# 242153Atlanta, United States
  • University of Maryland, Baltimore /ID# 242218Baltimore, United States
  • Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144Kansas City, United States
  • Northwell Health - Monter Cancer Center /ID# 245435Lake Success, United States
  • Icahn School of Medicine at Mount Sinai /ID# 242123New York, United States
  • Novant Health Presbyterian Medical Center /ID# 242148Charlotte, United States
  • East Carolina University - Brody School of Medicine /ID# 242506Greenville, United States
  • Novant Health Forsyth Medical Center /ID# 242198Winston-Salem, United States
  • Thomas Jefferson University Hospital /ID# 242077Philadelphia, United States
  • Fox Chase Cancer Center /ID# 242106Philadelphia, United States
  • Thompson Cancer Survival Ctr /ID# 242150Knoxville, United States
  • Joe Arrington Cancer Research /ID# 242226Lubbock, United States
  • Swedish Medical Center - Seattle /ID# 242269Seattle, United States
  • MultiCare Institute for Research and Innovation /ID# 242127Tacoma, United States
  • Beijing Cancer Hospital /ID# 252303Beijing, China
  • Fudan University Shanghai Cancer Center /ID# 252292Shanghai, China
  • Fakultni Nemocnice Brno - Jihlavska /ID# 242683Brno, Czechia
  • Fakultni Nemocnice Ostrava /ID# 242684Ostrava, Czechia
  • Vseobecna Fakultni nemocnice v Praze /ID# 242685Prague, Czechia
  • Fakultni nemocnice Hradec Kralove - Sokolska /ID# 241722Hradec Králové, Czechia
  • Aarhus Universitetshospital - Skejby /ID# 242670Aarhus, Denmark

And 51 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-505347-38-00
  • 2023-505347-38
Sources for references
clinicaltrials.gov

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