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

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

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 132 adult participants with NHL will be enrolled in 100 sites globally.

In the both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in combination with anti-neoplastic agents in 28-day cycles for arms 1 and 2 and 21- day cycles for arm 3.

Arm 1: SC epcoritamab in combination with oral lenalidomide in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Arm 2: SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in participants with with R/R DLBCL.

Arm 3: SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in participants with newly diagnosed treatment-naïve DLBCL.

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.

Trial Description

Primary Outcome:

  • Number of Participants with Dose-Limiting Toxicities (DLT)
Secondary Outcome:
  • Overall Response Rate (ORR) per Investigator
  • Duration of response (DOR) per Investigator
  • Number of Participants with Progression-free survival (PFS)
  • Percentage of Participants with Complete Response (CR)
  • Time-to-response (TTR)
  • Time to Next Anti-Lymphoma Therapy (TTNT)
  • Rate of Minimal Residual Disease (MRD) Negativity
  • Duration of Minimal Residual Disease (MRD) Negativity
  • Overall Survival (OS)

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society