Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03598608 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Efficacy of a Combination of Favezelimab (MK-4280) and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003)
A Phase 1 study of Lymphoma, Non-Hodgkin and Lymphoma, B-Cell, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 137
- Enrollment target
- 20
- Study locations
NCT03598608: Completed Phase 1 study of Lymphoma, Non-Hodgkin and Lymphoma, B-Cell, sponsored by Merck Sharp & Dohme.
NCT03598608 is a Phase 1 study of Lymphoma, Non-Hodgkin and Lymphoma, B-Cell that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 137 participants, below the 387-participant average among 58 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03598608, a Phase 1 study of Lymphoma, Non-Hodgkin and Lymphoma, B-Cell, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 137 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety and efficacy of favezelimab (MK-4280) in combination with pembrolizumab (MK-3475) using a non-randomized study design in participants with the following hematological malignancies: * classical Hodgkin lymphoma (cHL) * diffuse large B-cell lymphoma (DLBCL) * indolent non-Hodgkin lymphoma (iNHL) This study will also evaluate the safety and efficacy of pembrolizumab or favezelimab administered as monotherapy in participants with cHL using a 1:1 randomized study design. The study will have 2 phases: a safety lead-in and an efficacy expansion phase. The recommended Phase 2 dose (RP2D) will be determined in the safety lead-in phase by evaluating dose-limiting toxicities. There is no primary hypothesis for this study.
Primary Outcome
DLT will be defined as any drug-related adverse event (AE) observed during the DLT evaluation period (Cycle 1) that results in a change to a given dose or a delay in initiating the next cycle and reported as the percentage of participants experiencing a DLT defined by the National Cancer Institute Common Terminology for Adverse Events version 4.0.
Conditions Studied
Interventions
- BIOLOGICAL pembrolizumab
- BIOLOGICAL Favezelimab
Study Locations (20)
California
- City of Hope ( Site 0001) - Duarte
- Ronald Reagan UCLA Medical Center (Radiological Sciences) ( Site 0007) - Los Angeles
- Pacific Cancer Care ( Site 0006) - Monterey
- University of California San Francisco ( Site 0023) - San Francisco
Victoria
- Monash Health ( Site 0201) - Clayton
- St Vincent s Hospital (Melbourne) Limited ( Site 0202) - Fitzroy
Other
- Rambam Medical Center ( Site 0382) - Haifa
- Hadassah Ein Karem Jerusalem ( Site 0383) - Jerusalem
Arizona
- Banner MD Anderson Cancer Center ( Site 0020) - Gilbert
Massachusetts
- Dana Farber Cancer Institute ( Site 0002) - Boston
Pennsylvania
- Fox Chase Cancer Center ( Site 0019) - Philadelphia
Texas
- Texas Oncology-Austin Midtown ( Site 8002) - Austin
New South Wales
- Concord Repatriation & General Hospital ( Site 0203) - Concord
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2018-10-17 |
| Est. Completion | 2026-01-28 |
| Phase | Phase 1 |
What the finished NCT03598608 record still lists
NCT03598608 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, below the 387-participant average among 58 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (65% lower).
The record links to 3 conditions, with Lymphoma, Non-Hodgkin appearing as the primary indexed condition, and to 2 interventions - of which pembrolizumab is the first listed.
NCT03598608 names 20 study sites across 15 states, led by California, Victoria, Other.
Frequently Asked Questions
What is clinical trial NCT03598608 about?
NCT03598608 is a clinical study titled "Study to Evaluate the Safety and Efficacy of a Combination of Favezelimab (MK-4280) and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003)". This study will evaluate the safety and efficacy of favezelimab (MK-4280) in combination with pembrolizumab (MK-3475) using a non-randomized study design in participants with the following hematological malignancies: * classical Hodgkin lymphoma (cHL) * diffuse large B-cell lymphoma (DLBCL) * indol...
What is the current status of trial NCT03598608?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 137 participants. The study started on 2018-10-17. Estimated completion is 2026-01-28.
What conditions does trial NCT03598608 study?
This clinical trial studies the following conditions: Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Hodgkin Disease.
What interventions are being tested in trial NCT03598608?
The interventions under investigation include: pembrolizumab (BIOLOGICAL), Favezelimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03598608?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03598608 being conducted?
This trial has 20 study locations across Arizona, California, Massachusetts, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lymphoma, Non-Hodgkin
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03598608's enrollment target sits among peer trials
137 23rd of 58 higher than 36 of 58 other Lymphoma, Non-Hodgkin trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma, Non-Hodgkin trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.
RECRUITING · Phase 1
-
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
RECRUITING · Phase 1
-
CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies
RECRUITING · Phase 1
-
Tazemetostat and Venetoclax in Relapsed/Refractory Non-Hodgkin Lymphoma
RECRUITING · Phase 1
-
A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma
RECRUITING · Phase 1
-
DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05091424 · 137 participants · Phase 1
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
- NCT05655182 · 137 participants · Phase 1
A Study of BLB-201 RSV Vaccine in Infants and Children
- NCT06571669 · 137 participants · NA
BOOM-IBD2 Pivotal Clinical Trial
- NCT06644768 · 137 participants · Phase 1
A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI