Non Hodgkin Lymphoma Clinical Trial

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)

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has measurable disease, defined as ≥1 lesion that can be accurately measured in 2 dimensions with diagnostic quality cross sectional anatomic imaging (computed tomography or magnetic resonance imaging). Minimum measurement must be >15 mm in the longest diameter or >10 mm in the short axis
Is able to provide a core or excisional tumor biopsy for biomarker analysis from an archival (within 3 months) or newly obtained biopsy at screening
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)

Exclusion Criteria:

Has known clinically active central nervous system (CNS) involvement
Has received prior therapy with an anti-lymphocyte activation gene-3 (LAG-3) antibody
Has received chimeric antigen receptors (CAR)-T-cell therapy for cHL and DLBCL Cohorts
Has received prior anticancer therapy or thoracic radiation therapy within 14 days before the first dose of study treatment
Has ≥Grade 2 non-hematological residual toxicities from prior therapy
Has had a prior anticancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤Grade 1 or at baseline) from AEs due to agents administered ≥4 weeks earlier
Has received a live vaccine within 30 days prior to first dose of study treatment. Administration of killed vaccines are allowed
Has received an investigational agent or used an investigational device within 4 weeks prior to intervention administration
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
Has a known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
Has an active infection requiring intravenous systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has known, active hepatitis B or hepatitis C infection
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
Has had an allogeneic hematopoetic stem cell/solid organ transplantation within the last 5 years

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

174

Study ID:

NCT03598608

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 25 Locations for this study

See Locations Near You

Banner MD Anderson Cancer Center ( Site 0020)
Gilbert Arizona, 85234, United States More Info
Study Coordinator
Contact
480-256-3425
City of Hope ( Site 0001)
Duarte California, 91010, United States More Info
Study Coordinator
Contact
626-256-2405
Ronald Reagan UCLA Medical Center (Radiological Sciences) ( Site 0007)
Los Angeles California, 90095, United States More Info
Study Coordinator
Contact
310-582-4067
Pacific Cancer Care ( Site 0006)
Monterey California, 93940, United States More Info
Study Coordinator
Contact
831-375-4105
University of California San Francisco ( Site 0023)
San Francisco California, 94143, United States More Info
Study Coordinator
Contact
415-885-3882
Dana Farber Cancer Institute ( Site 0002)
Boston Massachusetts, 02215, United States
Fox Chase Cancer Center ( Site 0019)
Philadelphia Pennsylvania, 19111, United States
Texas Oncology-Austin Midtown ( Site 8002)
Austin Texas, 78705, United States
Concord Repatriation & General Hospital ( Site 0203)
Concord New South Wales, 2139, Australia More Info
Study Coordinator
Contact
+61397677341
Princess Alexandra Hospital ( Site 0204)
Woollongabba Queensland, 4102, Australia More Info
Study Coordinator
Contact
+61731766826
Monash Health ( Site 0201)
Clayton Victoria, 3168, Australia More Info
Study Coordinator
Contact
+61395946666
St Vincent s Hospital (Melbourne) Limited ( Site 0202)
Fitzroy Victoria, 3065, Australia More Info
Study Coordinator
Contact
+61398593936
BC Cancer ( Site 0107)
Vancouver British Columbia, V5Z 1, Canada More Info
Study Coordinator
Contact
6048776000
CancerCare Manitoba ( Site 0101)
Winnipeg Manitoba, R3E 0, Canada More Info
Study Coordinator
Contact
2047874156
Princess Margaret Cancer Centre ( Site 0100)
Toronto Ontario, M5G 2, Canada More Info
Study Coordinator
Contact
4169464501
Jewish General Hospital ( Site 0105)
Montreal Quebec, H3T 1, Canada More Info
Study Coordinator
Contact
5143408222 x 24572
U. klinikum Koeln AOER ( Site 0326)
Koeln Nordrhein-Westfalen, 50937, Germany More Info
Study Coordinator
Contact
+4922147897657
Universitaetsklinikum Leipzig AOeR ( Site 0327)
Leipzig Sachsen, 04103, Germany More Info
Study Coordinator
Contact
+493419720363
Rambam Medical Center ( Site 0382)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
+97247773109
Hadassah Ein Karem Jerusalem ( Site 0383)
Jerusalem , 91120, Israel More Info
Study Coordinator
Contact
+97226778243
Chaim Sheba Medical Center. ( Site 0380)
Ramat Gan , 52620, Israel More Info
Study Coordinator
Contact
+97235302588
Sourasky Medical Center ( Site 0381)
Tel Aviv , 64239, Israel More Info
Study Coordinator
Contact
+97236973782
A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 0351)
Bologna Emilia-Romagna, 40138, Italy More Info
Study Coordinator
Contact
+390516363680
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0354)
Meldola Forli-Cesena, 47014, Italy More Info
Study Coordinator
Contact
+390543739290
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0352)
Rozzano Milano, 20089, Italy More Info
Study Coordinator
Contact
+390282244080

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

174

Study ID:

NCT03598608

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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