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BRIEF TITLE: MK-7684 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

A Phase 1 Trial of MK-7684 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors


  • Org Study ID: 7684-001
  • Secondary ID: MK-7684-001
  • NCT ID: NCT02964013
  • NCT Alias:
  • Sponsor: Merck Sharp & Dohme Corp. - Industry
  • Source: Merck Sharp & Dohme Corp.

Brief Summary

This is a safety, efficacy, and pharmacokinetics study of MK-7684 as monotherapy and in combination with pembrolizumab (MK-3475) 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 phase. Part B is a dose confirmation phase to estimate the recommended Phase 2 dose (RPTD) for MK-7684 monotherapy or in combination with pembrolizumab. The anti-tumor activity of MK-7684 when used as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors will also be evaluated in Part B. The primary hypothesis is that MK-7684 administered as monotherapy or in combination with pembrolizumab is safe when administered at the RPTD.

Overal Status Start Date Phase Study Type
Recruiting December 13, 2016 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Number of Participants with Dose Limiting Toxicities (DLTs)

Primary Outcome 1 - Time Frame: Up to 24 Months

Condition:

  • Neoplasms
  • Non-small Cell Lung Carcinoma
  • Head and Neck Neoplasms
  • Urinary Bladder Neoplasms
  • Stomach Neoplasms

Eligibility

Criteria:
Inclusion Criteria:

- For Part A: has a histologically or cytologically confirmed metastatic solid tumor for
which there is no available therapy that is expected to convey clinical benefit

- For Part A (after restriction of tumor types) and Part B: has advanced metastatic
non-small cell lung cancer (NSCLC); urothelial tract cancer of the renal pelvis,
ureter, bladder, or urethra that is considered inoperable; adenocarcinoma of the
stomach and/or gastric-esophageal junction (GEJ) that is considered inoperable; or
head and neck squamous cell carcinoma (HNSCC) that is considered incurable by local
therapies such as surgical resection and/or radiation

- Has measureable disease by Response Evaluation Criteria In Solid Tumors (RECIST)

- Has an Eastern Cooperative Oncology Group performance status of 0 to 1

- Females must not be pregnant

- Women of childbearing potential and male participants must agree to use adequate
contraception for the course of the study

- Has provided a tumor tissue sample (archival or newly obtained core or excisional
biopsy of a tumor lesion)

Exclusion Criteria:

- Has had chemotherapy, radiation, biological cancer therapy or major surgery within 4
weeks prior to the first dose of study treatment

- Has not recovered to Common Toxicity Criteria for Adverse Events Grade 1 or better
from the adverse events due to cancer therapeutics administered more than 4 weeks
prior to the first dose of study treatment

- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks prior to the first dose of
study treatment

- Has received previous treatment with another agent targeting the T cell immunoglobulin
and immunoreceptor tyrosine-based inhibitory motif (TIGIT) receptor

- Has received previous treatment with an immunomodulatory agent (e.g., anti-programmed
cell death 1/ anti-programmed cell death ligand 1 or cytotoxic T-lymphocyte-associated
protein 4) and was discontinued from that treatment due to a Grade 3 or higher
immune-related adverse event

- Is expected to require any other form of antineoplastic therapy while participating in
the trial

- Is on chronic systemic steroid therapy in excess of replacement doses or on any other
form of immunosuppressive medication.

- Has a history of a previous additional malignancy unless potentially curative
treatment has been completed with no evidence of malignancy for 5 years

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

- Has an active autoimmune disease

- Has an active infection requiring systemic treatment

- Has interstitial lung disease

- Has active or past history of (non-infectious) pneumonitis requiring steroids

- Has symptomatic ascites or pleural effusion

- Has previously had a hematopoetic stem cell transplant or solid organ transplant

- Is known to be human immunodeficiency virus (HIV) positive and/or known to have active
chronic or acute Hepatitis B or Hepatitis C

- Has a known psychiatric and/or substance abuse disorder that would make it difficult
for the participant to cooperate with the requirements of the trial

- Is a regular user (including recreational use) of any illicit drugs at the time of
signing informed consent, or has a recent history (within the last year) of substance
abuse

- Has received a live-virus vaccine within 30 days prior to the first dose of study
treatment

- Has had hormonal cancer therapy (e.g., tamoxifen, leuprolide). within 4 weeks prior to
the first dose of study treatment
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Medical Director

Role: Study Director

Affiliation: Merck Sharp & Dohme Corp.

Overall Contact

Name: Toll Free Number

Phone: 1-888-577-8839

Email:

Locations

Facility Status Contact
Call for Information (Investigational Site 0001)
San Antonio, Texas 78229
United States
Recruiting
Merck Sharp & Dohme Co. Ltd.
Hod Hasharon,
Israel
Recruiting Gally Teper
972-9-9533310