A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)

Condition(s) studied

Investigational drug(s) / intervention(s)

MK-1045: Intravenous (IV) infusion

Rituximab: IV infusion

Rituximab biosimilar: IV infusion

Bendamustine: IV infusion

Cyclophosphamide: IV infusion

Vincristine: IV infusion

Prednisone: Per approved product label

Prednisolone: Per approved product label

Doxorubicin Hydrochloride: IV infusion

Study summary

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)

Eligibility

Primary outcome measure(s)

• Part 1: Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 15 months
  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 — Up to approximately 12 months
  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) — Up to approximately 36 days
  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 — Up to approximately 60 months
  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 2: Progression-Free Survival (PFS) — Up to approximately 63 months
  PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first.

Trial sites (25)

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