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JOURNAL ONKOLOGIE – STUDIE

Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)

Rekrutierend

NCT-Nummer:
NCT05853367

Studienbeginn:
Juli 2023

Letztes Update:
02.10.2023

Wirkstoff:
MK-0472, Pembrolizumab

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Merck Sharp & Dohme LLC

Collaborator:
-

Studienleiter

Medical Director
Study Director
Merck Sharp & Dohme LLC

Kontakt

Studienlocations
(3 von 7)

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001)
07601 Hackensack
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 551-996-5863» Ansprechpartner anzeigen
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0100)
H2X 0A9 Montréal
CanadaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 5148908444» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to assess the efficacy, safety, and tolerability of MK-0472

administered as monotherapy and in combination with pembrolizumab (MK-3475) in participants

with histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumors.

There is no primary hypothesis to be tested for this study.

Ein-/Ausschlusskriterien

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

- Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology

report with oncogenic receptor tyrosine kinase (RTK) pathway alterations confirmed by

a historical report or local testing and have received, or been intolerant to, all

available treatment known to confer clinical benefit

- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they

have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV

viral load prior to randomization

- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV

viral load is undetectable at screening

- Participants with human immunodeficiency virus (HIV) infection must have well

controlled HIV on stable (>4 weeks) antiretroviral therapy (ART)

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

- Has not recovered to common terminology criteria for adverse events (CTCAE) Grade 1 or

better from any adverse events that were due to cancer therapeutics administered more

than 4 weeks earlier. Participants receiving ongoing replacement hormone therapy for

endocrine immune-related AEs will not be excluded from participation in this study

- Has history of a second malignancy, unless potentially curative treatment has been

completed with no evidence of malignancy for 2 years

- History of hyperparathyroidism or hypercalcemia

- Has one or more of the following ophthalmological findings/conditions: a) Intraocular

pressure >21 mm Hg and/or any diagnosis of glaucoma b) Diagnosis of central serous

retinopathy, retinal vein occlusion, or retinal artery occlusion and c) Diagnosis of

retinal degenerative disease

- Has clinically significant cardiovascular disease

- Bullous exfoliative skin disorders of any grade

- Known hypersensitivity to MK-0472 or pembrolizumab, or any of their excipients

- Received therapy with a proton-pump inhibitor or an H2 histamine blocker receptor

antagonist within 7 days before the first scheduled day of study dosing

- Has discontinued prior therapy with an anti-programmed cell death-1 (PD-1),

anti-programmed death-ligand 1 (PD-L1), or anti-programmed death-ligand 2 (PD-L2)

agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor

due to an adverse event

- Received prior systemic anticancer therapy including investigational agents within 4

weeks before first dose

- Received a live or live-attenuated vaccine within 30 days before the first dose of

study intervention

- Has received an investigational agent or has used an investigational device within 4

weeks prior to study intervention administration

- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or

any other form of immunosuppressive therapy within 7 days prior to the first dose of

study medication

- Has known additional malignancy that is progressing or has required active treatment

within the past 2 years

- Has known active central nervous system (CNS) metastases and/or carcinomatous

meningitis. Participants with previously treated brain metastases may participate

provided they are radiologically stable for at least 4 weeks as confirmed by repeat

imaging performed during the study screening, are clinically stable and have not

required steroid treatment for at least 14 days before the first dose of study

intervention

- Has active autoimmune disease that has required systemic treatment in the past 2 years

except replacement therapy

- Has history of pneumonitis/interstitial lung disease that required steroids or has

current pneumonitis/interstitial lung disease

- Has active infection requiring systemic therapy

- Has history of allogeneic tissue/solid organ transplant

- Have not adequately recovered from major surgery or have ongoing surgical

complications

Studien-Rationale

Primary outcome:

1. Number of Participants Who Experience a Dose Limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Time Frame - At the end of Cycle 1 (each cycle is 21 days)):
DLT will be defined as any drug-related AE observed during the DLT evaluation period (e.g. Cycle 1) that results in a change to a given dose or a delay in initiating the next cycle.

2. Number of Participants Who Experience One or More Adverse Events (AEs) (Time Frame - Up to approximately 56 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. The number of participants who experience one or more AE's will be reported.

3. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) (Time Frame - Up to approximately 56 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. The number of participants who discontinue study treatment due to an AE will be reported.

Secondary outcome:

1. Area Under the Concentration Time-curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of MK-0472 (Time Frame - Cycle 1 Day 1; Cycle 2 Day 1: Predose and 1, 2, 4, and 8 hours postdose; Cycles 1, 2: Days 2, 15: Predose (Each cycle length = 21 days)):
Blood samples will be collected at specified intervals for the determination of AUC0-t. AUC0-t is defined as the area under concentration-time curve from 0 to last quantifiable concentration.

2. Lowest Plasma Concentration (Ctrough) of MK-0472 (Time Frame - Cycles 2-6, and every third cycle up to Cycle 81: Day 1: Predose (Each cycle length = 21 days)):
Blood samples will be collected at specified intervals for the determination of Ctrough. Ctrough is defined as the lowest concentration of MK-0472 reached before the next dose is administered.

3. Maximum Serum Concentration (Cmax) of MK-0472 (Time Frame - Cycle 1 Day 1; Cycle 2 Day 1: 1, 2, 4, and 8 hours postdose (Each cycle length = 21 days)):
Blood samples will be collected at specified intervals for the determination of Cmax. Cmax is defined as the maximum concentration of MK-0472 reached.

Studien-Arme

  • Experimental: MK-0472
    Participants receive MK-0472 capsule up to 300 mg orally once daily (QD) until disease progression or withdrawal/discontinuation.
  • Experimental: MK-0472 + Pembrolizumab
    Participants receive MK-0472 capsule up to 300 mg orally QD until disease progression or withdrawal/discontinuation plus pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).

Geprüfte Regime

  • MK-0472:
    Oral Administration
  • Pembrolizumab (MK-3475 / Keytruda® / ):
    IV infusion

Quelle: ClinicalTrials.gov


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