A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
Recruiting now · Phase 2/Phase 3
Conditions studied: Follicular Lymphoma
In brief
Researchers are looking for new ways to treat follicular lymphoma (FL). A standard (usual) treatment for FL includes a targeted therapy called rituximab and chemotherapy. In this study, researchers want to learn if giving a study medicine called MK-1045 and rituximab can treat FL. MK-1045 is a type of treatment called immunotherapy. The goals of this study are to learn: * About the safety of MK-1045 and rituximab, and if people tolerate them when given together * If people who receive MK-1045 and rituximab have the cancer go away * If people who receive MK-1045 and rituximab live longer without their cancer getting worse compared to those who receive standard treatment (rituximab and chemotherapy)
Key facts
- Study ID
- NCT07634471
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 960
- Starts
- 2026-06-22
- Expected to finish
- 2035-07-23
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has biopsy-proven, previously untreated, histologically confirmed cluster of differentiation (CD)19-positive and CD20-positive classical follicular lymphoma (FL), with Ann Arbor Stage II-IV disease and a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5.
- Has radiographically measurable disease per the Lugano Response Criteria.
- Has provided a newly obtained core or excisional biopsy or archival tissue of a tumor lesion not previously irradiated.
- If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy (ART).
- If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it.
- If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.
You may not qualify if…
- Has received prior systemic anticancer therapy or radiotherapy for FL.
- Has follicular large B-cell lymphoma or any other subtype of FL other than classical FL.
- Has FL that has transformed into a more aggressive type of lymphoma.
- History or presence of clinically relevant central nervous system (CNS) diseases.
- Has history of serious cardiovascular and cerebrovascular diseases.
- Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has known active CNS lymphoma or involvement.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- Has active infection requiring systemic therapy.
- Has chronic liver disease, including liver cirrhosis of Child-Pugh class B or C.
- Has not adequately recovered from major surgery or has ongoing surgical complications.
Where it is running
- Duke Cancer Center Clinic 1B/C Onc/Heme ( Site 1307) — Durham, North Carolina, United States (enrolling)
- SCRI Oncology Partners ( Site 7000) — Nashville, Tennessee, United States (enrolling)
- Sanatorio Nuestra Senora del Rosario ( Site 0104) — Rosario, Santa Fe Province, Argentina (enrolling)
- Hadassah Medical Center ( Site 0701) — Jerusalem, Israel (enrolling)
- Sheba Medical Center ( Site 0702) — Ramat Gan, Israel (enrolling)
- Sourasky Medical Center ( Site 0704) — Tel Aviv, Israel (enrolling)
- Institut Català d'Oncologia (ICO) - Badalona ( Site 0904) — Badalona, Barcelona, Spain (enrolling)
- Hospital Virgen de la Victoria ( Site 0905) — Málaga, Malaga, Spain (enrolling)
- Hospital Universitari Vall de Hebron ( Site 0903) — Barcelona, Spain (enrolling)
- Hospital Universitario Gregorio Maranon ( Site 0902) — Madrid, Spain (enrolling)
- Hospital Universitario de Salamanca ( Site 0906) — Salamanca, Spain (enrolling)
- National Taiwan University Hospital ( Site 1001) — Taipei, Taiwan (enrolling)
- Chang Gung Medical Foundation-Linkou Branch ( Site 1002) — Taoyuan, Taiwan (enrolling)
- Hacettepe Universite Hastaneleri ( Site 1110) — Ankara, Turkey (Türkiye) (enrolling)
- Sisli Florence Nightingale Hastanesi ( Site 1112) — Istanbul, Turkey (Türkiye) (enrolling)
- Ondokuz Mayıs Universitesi ( Site 1113) — Samsun, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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