Health TrialsbyHealthPanel

A Clinical Trial of MK-1045 in People With B-cell Cancer (MK-1045-006)

ConditionsChronic Lymphocytic LeukaemiaSmall Lymphocytic LymphomaHematologic Malignancies
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

Researchers are looking for new ways to treat people with B-cell cancers. In this trial, researchers will look at chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). These are blood cancers that affect B-cells in the blood, bone marrow, or lymph nodes.

The goals of this trial are to learn about:

* The safety of MK-1045 and if participants tolerate it. Tolerate means participants will receive trial treatment unless they need to stop treatment due to health problems. * The number of participants who respond. Respond means the number of cancer cells goes down or signs of cancer go away.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has histologically confirmed chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) active disease that is relapsed/refractory (r/r) to prior therapy.

Has confirmed CD19-positive disease.

If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy.

If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load.

Disqualifiers

Has a history of serious cardiovascular and cerebrovascular diseases.

Has a history or presence of central nervous system disease.

Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.

Has a diagnosis of immunodeficiency.

Trial design

Design model

Sequential

Treatments tested in this trial

  • MK-1045

    Biological/Vaccine

    Intravenous (IV) infusion

  • Acetaminophen (or similar antipyretic)

    Drug

    Oral administration as a premedication

  • Diphenhydramine (or similar antihistamine)

    Drug

    Per approved product label as a premedication

  • Dexamethasone

    Drug

    IV administration as a premedication

  • Tocilizumab

    Biological/Vaccine

    IV administration as a rescue medication

  • Tocilizumab biosimilar

    Biological/Vaccine

    IV administration as a rescue medication

  • Siltuximab

    Biological/Vaccine

    IV administration as a rescue medication

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Part 1: Dose FindingExperimental treatment 7 interventions
Group B: Part 2: Dose ExpansionExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Cohort A Part 1: Number of Participants Who Experience Dose-Limiting Toxicity (DLT)

DLT will be defined as any drug-related adverse event (AE) observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next dose.

Time frame
Up to approximately 29 days
2

Cohort A Part 1: Number of Participants Who Experience an AE

An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Time frame
Up to approximately 27 months
3

Cohort A Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE

An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Time frame
Up to approximately 24 months
4

Cohort A Parts 1 and 2: Objective Response Rate (ORR)

ORR is defined as the percentage of participants with complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or partial response (PR), per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by blinded independent central review (BICR).

Time frame
Up to approximately 66 months

Secondary outcomes

1

Cohort A Part 2: Number of Participants Who Experience 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.

Time frame
Up to approximately 27 months
2

Cohort A Part 2: 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.

Time frame
Up to approximately 24 months
3

Cohort A Parts 1 and 2: Duration of Response (DOR)

For participants who demonstrate a CR, CRi, nPR, or PR per iwCLL Criteria 2018 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR, CRi, nPR, or PR until disease progression or death due to any cause, whichever occurs first.

Time frame
Up to approximately 66 months
4

Cohort A Parts 1 and 2: Area Under the Curve at Steady State (AUCss) of MK-1045

Blood samples will be collected at designated timepoints to estimate the AUCss of MK-1045.

Time frame
Predose and at designated time points post-dose (up to approximately 24 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Merck Sharp & Dohme LLC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: