A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Genmab
Study ID
NCT04628494
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Epcoritamab — BIOLOGICAL
    Following mandatory pre-medication, participants will be administered epcoritamab as a subcutaneous injection.
  • Investigator's Choice Chemotherapy — DRUG
    Following mandatory pre-medication, participants will be administered intravenously either BR or R-GemOx.

Study Details

The purpose of this trial is to find out if epcoritamab, also known as EPKINLY™ and GEN3013, is safe and works well as treatment for participants with DLBCL that are not responding to treatment, have grown in size, or have come back following treatment with at least 1 prior systemic cancer therapy. All participants in this trial will be randomly assigned to receive either epcoritamab or a pre-specified investigator's choice (standard of care) chemotherapy (either rituximab + gemcitabine + oxaliplatin \[R-GemOx\], or bendamustine + rituximab \[BR\]). Participants must have failed or be ineligible to receive an autologous stem cell transplant (ASCT). Epcoritamab will be injected under the skin. Investigator's choice chemotherapy will be given intravenously. Trial details include: * The trial duration will be up to 5 years after last participant is randomized. * All trial participants have a 21-day screening period, a treatment period, and a follow-up period that continues until death. * The estimated trial duration for an individual participant depends upon the treatment arm assigned: * Participants who receive epcoritamab will have 28-day treatment cycles. Epcoritamab will be given once weekly for the first 3 months, then every other week for 6 months, then every 28 days until lymphoma progression or unacceptable adverse events. * Participants who receive investigator's choice (standard of care) chemotherapy will receive treatments either: * R-GemOx: On Day 1 (or Day 1 \& Day 2), and Day 15 (or Day 15 \& Day 16) every 28 days, for up to 4 months; or * BR: On Day 1 and Day 2 every 3 weeks for up to 4.5 months.

Key Dates

Start date
Jan 13, 2021
Status verified
May 2026
Primary completion
Oct 13, 2025
Completion
Apr 30, 2028

Study Design

Enrollment
483 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Epcoritamab (GEN3013; DuoBody®CD3xCD20)
    Epcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met
  • Active Comparator: Investigator's choice of chemotherapy
    R-GemOx will be administrated in Cycles of 28 days until maximum cycles completion or any of the discontinuation criteria is met BR will be administrated in Cycles of 21 days until maximum cycles completion or any of the discontinuation criteria is met

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 5 years ]

Locations (15)

FacilityCityStateZIPSite coordinators
Community Health Network Cancer Center NorthIndianapolisIndiana46250-
Indiana Blood and Marrow TransplantationIndianapolisIndiana46237-
University of Kentucky Markey Cancer CenterLexingtonKentucky40536-
Henry Ford Health SystemJacksonMichigan49201-
MMCORC Attn Delaney AndersonSaint Louis ParkMinnesota55416-
MD Anderson Cancer Center at CooperCamdenNew Jersey08103-
Wake Forest Baptist HealthWinston-SalemNorth Carolina27157-
The Christ Hospital Cancer CenterCincinnatiOhio45229-
TriHealth Cancer Institute- Good Samaritan HospitalCincinnatiOhio45247-
Brooke Army Medical CenterFort Sam HoustonTexas78234-
Community Cancer Trials of UtahOgdenUtah84405-
LDS HospitalSalt Lake CityUtah84143-
Virginia Commonwealth University (VCU) Massey Cancer CenterRichmondVirginia23298-
North Star Lodge Cancer CenterYakimaWashington98902-
Waukesha Memorial HospitalWaukeshaWisconsin53188-

Related coverage on Hipa.ai

Find similar trials in Indianapolis, IN

By research site
Community Health Network Cancer Center North· Indianapolis, INIndiana Blood and Marrow Transplantation· Indianapolis, INUniversity of Kentucky Markey Cancer Center· Lexington, KYHenry Ford Health System· Jackson, MIMMCORC Attn Delaney Anderson· Saint Louis Park, MNMD Anderson Cancer Center at Cooper· Camden, NJ

Related Studies