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)
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).
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.
Parallel
MK-1045
Biological/VaccineIntravenous (IV) infusion
Rituximab
Biological/VaccineIV infusion
Rituximab biosimilar
Biological/VaccineIV infusion
Bendamustine
DrugIV infusion
Cyclophosphamide
DrugIV infusion
Vincristine
DrugIV infusion
Prednisone
DrugPer approved product label
Prednisolone
DrugPer approved product label
Doxorubicin Hydrochloride
DrugIV infusion
Part 1: Number of Participants Who Experience an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Part 1: Number of Participants Who Experience Dose Limiting Toxicity (DLT)
DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle.
Part 1: Complete Response (CR) Rate
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) per Lugano response criteria. CR rate is defined as the percentage of participants who experience a CR. The CR rate as assessed by physician investigator will be presented.
Part 1: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with CR (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Lugano response criteria. The percentage of participants who experience CR or PR as assessed by physician investigator will be presented.
Part 1: Duration of CR
For participants who demonstrate CR (CR: disappearance of all target lesions) at end of treatment per Lugano response criteria, defined as the time from the first documented evidence of CR until disease progression or death due to any cause, whichever occurs first.
Part 1: Area Under the Concentration-Time Curve at Steady State (AUCss) of MK-1045
Blood samples will be collected at multiple time points to estimate the AUCss of MK-1045.
Part 1: Maximum Concentration (Cmax) of MK-1045
Blood samples will be collected at multiple time points to estimate the Cmax of MK-1045.
Click on the lead sponsor to view all of their trials.
