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A Clinical Trial of MK-6255 to Treat Endometrial and Ovarian Cancer (MK-6255-001)

ConditionsOvarian NeoplasmsEndometrial Neoplasms
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

Researchers are looking for new ways to treat advanced and recurrent endometrial cancer (EC) and ovarian cancer (OC). Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. Recurrent means the cancer came back after treatment.

MK-6255 is a trial medicine designed to treat advanced and recurrent EC and OC. This trial is the first time that researchers will give MK-6255 to people.

The goals of this trial are to learn about:

* The safety of MK-6255 and if participants tolerate it. Tolerate means participants will receive the trial medicine unless they need to stop it due to health problems. * What happens to different dose levels (amounts) of MK-6255 in the body over time.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Recurrent, pathologically documented epithelial OC, primary peritoneal cancer, or fallopian tube cancer that is either (1) platinum resistant or (2) platinum sensitive, with progression during prior treatment with poly-adenosine diphosphate (ADP) ribose polymerase inhibitor (PARPi)

Histologically confirmed well, moderately, or poorly differentiated (ie, Grade 1 to Grade 3) serous or endometrioid EC that has progressed after at least 1 line of platinum-based therapy in any setting

Has received all protocol-required and available standard of care (SOC) therapies, unless ineligible for or intolerant to the therapies

Has provided archival tumor tissue or a recently obtained biopsy before treatment start

Disqualifiers

Has a diagnosis of any 1 of the following: Primary platinum-refractory OC; neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas; carcinosarcoma; EC that is amenable to curative-intent surgery or curative-intent radiotherapy; or EC that requires recurrent drainage of effusions

Has a history of serious cardiovascular and cerebrovascular diseases

Has a history or presence of clinically relevant central nervous system (CNS) diseases

Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) before start of study intervention

Trial design

Design model

Sequential

Treatments tested in this trial

  • MK-6255

    Biological/Vaccine

    During initial dose escalation, participants will receive MK-6255 one weekly (QW). During Dose Interval Extension, participants will receive target doses every 3 weeks (Q3W).

  • CD8 PET Tracer

    Other intervention

    Participants may receive an optional CD8 PET tracer for exploratory imaging assessments.

  • Acetaminophen

    Drug

    Participants will receive acetaminophen (or similar antipyretic) as premedication.

  • Diphenhydramine

    Drug

    Participants will receive diphenhydramine (or similar antihistamine) as premedication.

  • Dexamethasone

    Drug

    Participants will receive dexamethasone as premedication.

  • Tocilizumab

    Biological/Vaccine

    Participants will receive this rescue medication at the investigator's discretion for treatment of cytokine release syndrome (CRS) after MK-6255 administration.

  • Tocilizumab biosimilar

    Biological/Vaccine

    Participants will receive this rescue medication at the investigator's discretion for treatment of cytokine release syndrome (CRS) after MK-6255 administration.

  • Siltuximab

    Biological/Vaccine

    Participants will receive this rescue medication at the investigator's discretion for treatment of cytokine release syndrome (CRS) after MK-6255 administration.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Dose EscalationExperimental treatment 8 interventions
Group B: Dose Interval ExtensionExperimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Number of Participants Who Experience a Dose-limiting Toxicity (DLT) as Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 6.0

A DLT is defined as any drug-related AE observed during the DLT evaluation period that meet criteria specified in the protocol. DLTs will be evaluated until 21 days after the first fixed dose during fixed-dose escalation and until 21 days after the first target dose during step-up dose escalation and dose interval extension.

Time frame
Up to 21 days at each dose level
2

Number of participants who experience one or more adverse events (AEs)

An AE is 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. The number of participants that experience AEs will be reported.

Time frame
Up to approximately 56 months
3

Number of participants who discontinue study intervention due to an adverse event (AE)

An AE is 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. The number of participants that discontinue study intervention due to an AE will be reported.

Time frame
Up to approximately 56 months

Secondary outcomes

1

Area Under the Serum Concentration-Time Curve (AUC) of MK-6255

AUC is defined as the measure of overall drug exposure over time after administration. Blood samples will be collected to determine the AUC of MK-6255.

Time frame
At designated timepoints (up to approximately 2 weeks postdose)
2

Minimum Serum Concentration (Cmin) of MK-6255

Cmin is defined as the lowest observed concentration of a drug after administration. Blood samples will be collected to determine the Cmin of MK-6255.

Time frame
At designated timepoints (up to approximately 2 weeks postdose)
3

Maximum Serum Concentration (Cmax) of MK-6255

Cmax is defined as the highest observed concentration of a drug after administration. Blood samples will be collected to determine the Cmax of MK-6255.

Time frame
At designated timepoints (up to approximately 2 weeks postdose)
4

Time to Maximum Serum Concentration (Tmax) of MK-6255

Tmax is defined as the time at which the maximum observed concentration of a drug occurs after administration. Blood samples will be collected to determine the Tmax of MK-6255.

Time frame
At designated timepoints (up to approximately 2 weeks postdose)

Other outcomes

Locations

This trial has no locations.

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: