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A Study of MK-1088 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-1088-002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05394350
Recruitment Status : Recruiting
First Posted : May 27, 2022
Last Update Posted : October 21, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Brief Summary:
The study will evaluate the safety, tolerability, and pharmacokinetics (PK) of MK-1088 in monotherapy and in combination with pembrolizumab in participants with advanced solid tumors who have not responded to conventional therapy. The effect of MK-1088 on tumor size will also be examined.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: MK-1088 Biological: Pembrolizumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/Phase 2 Study to Evaluate the Safety and Tolerability of MK-1088 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
Actual Study Start Date : July 7, 2022
Estimated Primary Completion Date : November 10, 2025
Estimated Study Completion Date : November 10, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MK-1088
Participants will receive MK-1088 daily (QD) orally at specified dose on days 1-21 of each 21-day cycle for up to 35 cycles (up to ~24 months).
Drug: MK-1088
Oral Tablet

Experimental: MK-1088 + Pembrolizumab
Participants will receive MK-1088 daily (QD) orally at specified dose on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months).
Drug: MK-1088
Oral Tablet

Biological: Pembrolizumab
IV Infusion
Other Names:
  • MK-3475
  • KEYTRUDA®




Primary Outcome Measures :
  1. Number of participants experiencing a dose-limiting toxicity (DLT) [ Time Frame: Up to 21 days ]
    A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Number of participants who experience a DLT will be reported.

  2. Number of participants experiencing an adverse event (AE) [ Time Frame: Up to ~27 months ]
    An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experienced an AE will be reported.

  3. Number of participants discontinuing study treatment due to an AE [ Time Frame: Up to ~24 months ]
    An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinued study treatment due to an AE will be reported.


Secondary Outcome Measures :
  1. Area under the plasma concentration-time curve (AUC) of MK-1088 [ Time Frame: Pre-dose and 1, 2, 4, and 8 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1; Pre-dose on Cycle 1 Day 2 and Cycle 2 Day 2; Pre-dose on Cycle 3, Cycle 4 and every 4 cycles up to ~27 months. Each cycle = 21 days ]
    AUC of MK-1088 determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.

  2. Maximum plasma concentration (Cmax) of MK-1088 [ Time Frame: Pre-dose and 1, 2, 4, and 8 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1; Pre-dose on Cycle 1 Day 2 and Cycle 2 Day 2; Pre-dose on Cycle 3, Cycle 4 and every 4 cycles up to ~27 months. Each cycle = 21 days ]
    Cmax of MK-1088 determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.

  3. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by investigator [ Time Frame: Up to ~3 years ]
    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 RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by the investigator based on RECIST 1.1 will be reported.

  4. ORR per Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by investigator [ Time Frame: Up to ~3 years ]
    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 PCWG-modified RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by the investigator based on PCWG-modified RECIST 1.1 will be reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Inclusion Criteria:

  • Has a histologically- or cytologically-confirmed diagnosis of advanced/metastatic solid tumor by pathology report and have received, have been intolerant to, or have been ineligible for treatment known to confer clinical benefit
  • For metastatic castrate-resistant prostate cancer (mCRPC) only: (1) Must have previously received docetaxel, prior treatment with one other chemotherapy is allowed as well as up to 2 second-generation hormonal manipulations and (2) have prostate cancer progression within 6 months before screening, as determined by the investigator
  • If human immunodeficiency virus (HIV) positive, has well-controlled HIV on anti-retroviral therapy (ART)

Exclusion Criteria:

  • Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study intervention
  • Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
  • Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has an active infection requiring therapy
  • Has a history of interstitial lung disease
  • Has a history of (noninfectious) pneumonitis that required steroids or current pneumonitis
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years
  • Has concurrent active Hepatitis B and Hepatitis C virus infection
  • Has HIV with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has not fully recovered from any effects of major surgery without significant detectable infection
  • Has a history or current evidence of a gastrointestinal (GI) condition or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption or metabolism of oral medications
  • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
  • Has a QTcF >470 msec
  • Has history of an allogeneic stem cell transplant or a solid organ transplant.
  • Has received prior systemic anticancer therapy including investigational agents within 4 weeks before allocation
  • Has received prior radiotherapy within 2 weeks of start of study intervention, or had radiation-related toxicities requiring corticosteroids
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Has a "superscan" bone scan

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05394350


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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United States, Florida
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0103) Recruiting
Miami, Florida, United States, 33136
Contact: Study Coordinator    305-243-1287      
United States, New York
Laura and Isaac Perlmutter Cancer Center ( Site 0102) Recruiting
New York, New York, United States, 10016
Contact: Study Coordinator    917-991-4174      
United States, Texas
South Texas Accelerated Research Therapeutics (START) ( Site 0101) Recruiting
San Antonio, Texas, United States, 78229
Contact: Study Coordinator    210-593-5265      
Canada, Ontario
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0201) Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Study Coordinator    4169464534      
Canada, Quebec
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0 Recruiting
Quebec City, Quebec, Canada, G1J 1Z4
Contact: Study Coordinator    418-525-4444 Ext.15768      
Denmark
Rigshospitalet ( Site 0500) Recruiting
Copenhagen, Hovedstaden, Denmark, 2100
Contact: Study Coordinator    +45 35 45 35 45      
Herlev and Gentofte Hospital ( Site 0501) Recruiting
Copenhagen, Hovedstaden, Denmark, 2730
Contact: Study Coordinator    +45 38 68 38 68      
Odense Universitetshospital ( Site 0502) Recruiting
Odense, Syddanmark, Denmark, 5000
Contact: Study Coordinator    0045 66113333      
Switzerland
Kantonsspital Graubünden-Medizin ( Site 0402) Recruiting
Chur, Grisons, Switzerland, 7000
Contact: Study Coordinator    41812566884      
Cantonal Hospital St.Gallen ( Site 0403) Recruiting
st.Gallen, Sankt Gallen, Switzerland, 9007
Contact: Study Coordinator    41714941111      
Ospedale Regionale Bellinzona e Valli ( Site 0400) Recruiting
Bellinzona, Ticino, Switzerland, 6500
Contact: Study Coordinator    41918118931      
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharpe & Dohme LLC
Additional Information:
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05394350    
Other Study ID Numbers: 1088-002
MK-1088-002 ( Other Identifier: Merck )
2021-006712-93 ( EudraCT Number )
First Posted: May 27, 2022    Key Record Dates
Last Update Posted: October 21, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents