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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Genmab
Study ID
NCT05283720
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epcoritamab — DRUG
    Subcutaneous Injection (SC)
  • Lenalidomide — DRUG
    Oral; Capsule
  • Ibrutinib — DRUG
    Oral; Capsule
  • Rituximab — DRUG
    Intravenous (IV); Injection
  • Cyclophosphamide — DRUG
    IV; Injection
  • Doxorubicin Hydrochloride [HCl] — DRUG
    IV; Injection
  • Prednisone — DRUG
    Oral; Tablet
  • Polatuzumab Vedotin — DRUG
    IV; Injection
  • CC-99282 — DRUG
    Oral; Capsule

Study Details

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.

Key Dates

Start date
Jun 14, 2022
Status verified
Jun 2026
Primary completion
Nov 30, 2032
Completion
Nov 30, 2032

Study Design

Enrollment
496 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Dose Escalation
    Participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) will receive escalating doses of epcoritamab in combination with lenalidomide in 28 day cycles.
  • Experimental: Arm 2: Dose Escalation
    Participants with R/R DLBCL will receive escalating doses of epcoritamab in combination with ibrutinib and lenalidomide in 28 day cycles.
  • Experimental: Arm 3: Dose Escalation
    Participants with newly diagnosed treatment-naïve DLBCL will receive escalating doses of epcoritamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin hydrochloride (HCl), and prednisone (pola-R-CHP) in 21 day cycles.
  • Experimental: Arm 4: Dose Escalation
    Participants with R/R DLBCL will receive escalating doses of epcoritamab in combination with CC-99282 in 28 day cycles.
  • Experimental: Arm 5: Dose Escalation
    Participants with R/R follicular lymphoma (FL) will receive escalating doses of epcoritamab in combination with CC-99282 in 28 day cycles.
  • Experimental: Arm 6A: Dose Escalation
    Participants with R/R mantle cell lymphoma (MCL) will receive escalating doses of epcoritamab in combination with ibrutinib in 28 day cycles.
  • Experimental: Arm 1: Dose Expansion
    Participants with R/R DLBCL will receive the recommended dose of epcoritamab in combination with lenalidomide in 28 day cycles.
  • Experimental: Arm 2: Dose Expansion
    Participants with R/R DLBCL will receive the recommended dose of epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.
  • Experimental: Arm 3: Dose Expansion
    Participants newly diagnosed treatment-naïve DLBCL will receive the recommended dose of epcoritamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin hydrochloride (HCl), and prednisone (pola-R-CHP) in 21 day cycles.
  • Experimental: Arm 3B: Dose Expansion
    Participants newly diagnosed treatment-naïve DLBCL will receive the recommended dose of epcoritamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin hydrochloride (HCl), and prednisone (pola-R-CHP), in 21 day cycles,until unacceptable toxicity, withdrawal of consent, or completion of treatment.
  • Experimental: Arm 4: Dose Expansion
    Participants with R/R DLBCL will receive the recommended dose of epcoritamab in combination with CC-99282 in 28 day cycles.
  • Experimental: Arm 5: Dose Expansion
    Participants with R/R FL will receive the recommended dose of epcoritamab in combination with CC-99282 in 28 day cycles.
  • Experimental: Arm 6: Dose Expansion
    Participants with R/R MCL will receive the recommended dose of epcoritamab in combination with ibrutinib in 28 day cycles.

Primary Outcome Measure

Number of Participants with Dose-Limiting Toxicities (DLT) [ Time Frame: Up to Approximately 5 Years ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
The University of Arizona Cancer Center - North Campus /ID# 242219TucsonArizona85719-
Yale University School of Medicine /ID# 242089New HavenConnecticut06510-
Christiana Care Health Service /ID# 242301NewarkDelaware19713-
Tampa General Hospital /ID# 246748TampaFlorida33606-
Winship Cancer Institute of Emory University /ID# 242153AtlantaGeorgia30322-
University of Maryland, Baltimore /ID# 242218BaltimoreMaryland21201-
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144Kansas CityMissouri64114-4859-
Northwell Health - Monter Cancer Center /ID# 245435Lake SuccessNew York11042-
Icahn School of Medicine at Mount Sinai /ID# 242123New YorkNew York10029-
Novant Health Presbyterian Medical Center /ID# 242148CharlotteNorth Carolina28204-
East Carolina University - Brody School of Medicine /ID# 242506GreenvilleNorth Carolina27834-
Novant Health Forsyth Medical Center /ID# 242198Winston-SalemNorth Carolina27103-
Fox Chase Cancer Center /ID# 242106PhiladelphiaPennsylvania19111-
Thomas Jefferson University Hospital /ID# 242077PhiladelphiaPennsylvania19107-
Thompson Cancer Survival Ctr /ID# 242150KnoxvilleTennessee37916-
Joe Arrington Cancer Research /ID# 242226LubbockTexas79410-
Swedish Medical Center - Seattle /ID# 242269SeattleWashington98104-
MultiCare Institute for Research and Innovation /ID# 242127TacomaWashington98405-

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The University of Arizona Cancer Center - North Campus· Tucson, AZYale University School of Medicine· New Haven, CTChristiana Care Health Service· Newark, DETampa General Hospital· Tampa, FLWinship Cancer Institute of Emory University· Atlanta, GAUniversity of Maryland, Baltimore· Baltimore, MD

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