Health TrialsbyHealthPanel

A Clinical Trial of MK-2010 Alone and With Other Treatments in Participants With Advanced Solid Tumors (MK-2010-002)

ConditionsMalignant NeoplamAdvanced Solid Tumors
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 certain types of advanced solid tumors. Solid tumors are cancers mostly in organs and tissues in the body, not in the blood or other fluids. Advanced means the cancer has spread nearby or to other parts in the body and cannot be removed with surgery.

In this trial, researchers want to learn if the trial medicine called MK-2010, given alone or with other treatments, can treat advanced solid tumors. MK-2010 is designed to help the immune system fight cancer.

The goals of this trial are to learn:

* About the safety of MK-2010 as monotherapy and in combinations and if participants tolerate them. Tolerate means participants will receive trial treatment unless they need to stop it due to health problems. * How many participants who receive MK-2010 as monotherapy and in combination respond to treatment. Respond means the cancer gets smaller or goes away.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has radiographically measurable disease per protocol

If to receive oral study treatment, has the ability to swallow and retain oral medication and does not have gastrointestinal abnormalities that may alter absorption

Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART) if diagnosed with HIV

Has adequate organ function per protocol

Disqualifiers

Has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease if diagnosed with HIV

Has a history of posterior reversible encephalopathy syndrome (PRES) or seizure disorder

Has hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe liver cirrhosis

Has a history of confirmed inflammatory bowel disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • MK-2010

    Biological/Vaccine

    Administered as an intravenous (IV) infusion.

  • Pembrolizumab

    Biological/Vaccine

    Administered intravenously as 400 mg every 6 weeks.

  • 5-Fluorouracil

    Drug

    Administered intravenously per approved product label.

  • Leucovorin or Levoleucovorin

    Drug

    Administered intravenously per approved product label.

  • Oxaliplatin

    Drug

    Administered intravenously per approved product label.

  • Belzutifan

    Drug

    Administered orally as 120 mg daily.

  • Gemcitabine

    Drug

    Administered intravenously per approved product label.

  • Cisplatin

    Drug

    Administered intravenously per approved product label.

  • Carboplatin

    Drug

    Administered intravenously per approved product label.

  • Paclitaxel

    Drug

    Administered intravenously per approved product label.

  • Nab-paclitaxel

    Drug

    Administered intravenously per approved product label.

  • Pemetrexed

    Drug

    Administered intravenously per approved product label.

  • Epinephrine

    Drug

    Administered per approved product label as rescue medication.

Treatment groups

480 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: MK-2010 + FOLFOXExperimental treatment 5 interventions
Group B: Pembrolizumab + FOLFOXActive comparator 5 interventions
Group C: MK-2010 MonotherapyExperimental treatment 2 interventions
Group D: MK-2010 + BelzutifanExperimental treatment 3 interventions
Group E: MK-2010 + Gemcitabine/CisplatinExperimental treatment 4 interventions
Group F: MK-2010 + Carboplatin and Paclitaxel/Nab-paclitaxelExperimental treatment 5 interventions
Group G: MK-2010 + Pemetrexed and Cisplatin/CarboplatinExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Number of Participants with 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Time frame
Up to approximately 24 months
2

Number of Participants Who Discontinue Study Treatment Due to an 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Time frame
Up to approximately 24 months
3

Number of Participants Who Experience Dose-Limiting Toxicity (DLT)

DLT is 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 28 days
4

Objective Response Rate (ORR)

ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

Time frame
Up to approximately 24 months

Secondary outcomes

1

Duration of Response (DOR)

For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

Time frame
Up to approximately 48 months
2

Area Under the Curve From Time 0 to Last (AUC0-last) of MK-2010

Blood samples will be collected to determine the AUC0-last of MK-2010.

Time frame
Predose and at designated time points up to approximately 24 months
3

Area Under the Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of MK-2010

Blood samples will be collected to determine the AUC0-tau of MK-2010.

Time frame
Predose and at designated time points up to approximately 24 months
4

Trough Concentration (Ctrough) of MK-2010

Blood samples will be collected to determine Ctrough of MK-2010.

Time frame
Predose and at designated time points 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: