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Study of MK-4166 and MK-4166 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4166-001)

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ClinicalTrials.gov Identifier: NCT02132754
Recruitment Status : Active, not recruiting
First Posted : May 7, 2014
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

This is a 5-part dose-escalation study to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of MK-4166 in participants with advanced solid tumors. In Part A, MK-4166 doses will be escalated quickly in successive cohorts and based on safety events may progress to Part B, in which the preliminary MTD will be identified. Based on safety events the study may progress to Part C in which the MTD will be confirmed. In Part D, participants will receive escalating doses of MK-4166 plus a fixed dose of pembrolizumab (MK-3475) 200 mg to determine the MTD for MK-4166 in combination with pembrolizumab. Based on safety events in Part D, the study may progress to Part E in which the MTD for MK-4166 in combination with pembrolizumab will be confirmed.

With Amendments 05/06, the dose confirmation Part E (combination of MK-4166 and pembrolizumab) will be limited to participants with advanced malignant melanoma.

The primary study hypotheses are that MK-4166 as a single agent and MK-4166 in combination with pembrolizumab have acceptable safety and tolerability.


Condition or disease Intervention/treatment Phase
Solid Tumor Biological: MK-4166 Biological: Pembrolizumab Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Trial of Single Agent MK-4166 and MK-4166 in Combination With Pembrolizumab in Subjects With Advanced Malignancies
Actual Study Start Date : June 27, 2014
Estimated Primary Completion Date : October 17, 2019
Estimated Study Completion Date : October 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MK-4166
Participants receive MK-4166 at assigned dose, intravenously over 30 minutes, on Day 1 of each 21-day cycle, for up to 4 cycles.
Biological: MK-4166
Experimental: MK-4166+Pembrolizumab
Participants receive MK-4166 at assigned dose, intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 4 cycles and receive pembrolizumab 200 mg, intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 24 months.
Biological: MK-4166
Biological: Pembrolizumab



Primary Outcome Measures :
  1. Number of participants experiencing dose-limiting toxicities (DLTs) with MK-4166 and with MK-4166+Pembrolizumab [ Time Frame: Cycle 1 (up to 21 days) ]
  2. Number of participants experiencing adverse events (AEs) [ Time Frame: From first dose up to 30 days post last dose (up to 25 months) ]
  3. Number of participants discontinuing study drug due to AEs [ Time Frame: Up to 24 months ]


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

Inclusion criteria:

  • Has a histologically- or cytologically-confirmed metastatic solid tumor for which there is no available therapy which may convey clinical benefit. Part E: Has advanced malignant melanoma.
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
  • Adequate organ function
  • Female participants of childbearing potential must have a negative urine or serum pregnancy test and must be surgically sterile or willing to use 2 methods of birth control or abstain from heterosexual activity for the course of the study through 120 days after last dose of study drug
  • Male participants must agree to use an adequate method of contraception during sexual contact with females of childbearing potential starting with the first dose of study drug through 180 days after the last dose of study drug
  • Submit an evaluable tumor sample for analysis.

Exclusion criteria:

  • Chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to the first dose of study drug, or who has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the adverse events due to cancer therapeutics administered more than 4 weeks earlier
  • Currently participating or has participated in a study of an investigational agent or using an investigational device within 28 days of administration of MK-4166
  • Expected to require any other form of antineoplastic therapy while on study
  • On chronic systemic steroid therapy in excess of replacement doses, or on any other form of immunosuppressive medication
  • History of a malignancy for which potentially curative treatment has been completed, with no evidence of malignancy for 5 years excepting successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, or in situ cervical cancer
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Severe hypersensitivity reaction to treatment with another monoclonal antibody
  • Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy
  • Active infection requiring therapy
  • Current pneumonitis, or a history of (non-infectious) pneumonitis that required steroids
  • Prior stem cell or bone marrow transplant
  • Positive for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Regular user (including "recreational use") of any illicit drugs or recent history (within the last year) of substance abuse (including alcohol)
  • Symptomatic ascites or pleural effusion
  • Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study
  • Clinically significant heart disease
  • Major surgery in the past 16 weeks
  • Received a live vaccine within 30 days prior to first dose of study drug

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): NCT02132754


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02132754     History of Changes
Other Study ID Numbers: 4166-001
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Pembrolizumab
Antineoplastic Agents