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  • MK7684-001

    Acronym: 

    MK7684

    ACTRN/NCT /ethics: 

    NCT02964013

    Scientific title: 

    A Phase I trial of MK-7684 as monotherapy and in combination with pembrolizumab in subjects with advanced solid tumours.

    Summary of trial and patient characteristics

    Cancer Type All cancers
    Trial Type Treatment
    Phase Phase I Tumour Stream Solid tumours
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced, Metastatic or Widespread
    Sex Both Anticipated Start Date 2016-12-13
    Molecular Target Anticipated End Date 2022-06-03
    Cancer Type All cancers
    Trial Type Treatment
    Phase Phase I
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Solid tumours
    Cancer Stage Locally Recurrent or Locally Advanced, Metastatic or Widespread
    Anticipated Start Date 2016-12-13
    Anticipated End Date 2022-06-03

    Trial Summary

    This is a safety, efficacy, and pharmacokinetics (PK) study of MK-7684 as monotherapy and in combination with pembrolizumab (MK-3475) or pembrolizumab plus pemetrexed and carboplatin in adults with metastatic solid tumors for which there is no available therapy that is expected to convey clinical benefit. Part A of this study is a dose escalation and confirmation phase to estimate the recommended Phase 2 dose (RPTD) for MK-7684 monotherapy or in combination with pembrolizumab, pemetrexed, and carboplatin. Part A will also evaluate the anti-tumor activity of MK-7684 in combination with pembrolizumab plus pemetrexed and carboplatin in participants with non-small cell lung cancer (NSCLC) and MK-7684 (at two dose levels) in combination with pembrolizumab in Japanese participants with gastric cancer. Part B will evaluate the anti-tumor activity of MK-7684 at the RPTD when used as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors in a non-randomized study design. Part B will also evaluate 2 doses of MK-7684 in combination with pembrolizumab in participants with programmed death 1 (PD-1) treatment naïve cancer using a 1:1 randomized study design. Part B is expanded with Amendment 11 to include an additional arm that will compare the safety and PK of a fixed dose of MK-7684A, a co-formulated product of MK-7684 plus pembrolizumab, to MK-7684 in combination with pembrolizumab administered as separate intravenous infusions. The primary hypotheses are that MK-7684 administered as monotherapy or in combination with pembrolizumab is safe and tolerable when administered at the RPTD and that MK-7684A is safe and tolerable when administered as a fixed dose.

    Lay Summary

    A Phase I trial of MK-7684 as monotherapy and in combination with pembrolizumab in subjects with advanced solid tumours.

    Sponsor / Cooperative group

    Merck

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Ashford Cancer Centre Research Sue Yeend syeend@adelaidecancercentre.com.au 08 8292 2240 Dr Brian Stein Recruiting