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Closed (no longer recruiting)Last updated: 7 February 2024

MK-7684-001: This phase I trial is evaluating a new immunotherapy drug (MK-7684) alone and in combination with another immunotherapy drug (Pembrolizumab) in patients with advanced solid tumoursA Phase 1 Trial of MK-7684 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Clinical summary

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 be evaluated in Part B 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. The primary hypothesis is that MK-7684 administered as monotherapy or in combination with pembrolizumab is safe when administered at the RPTD. MK-7684 will be administered as an intravenous (IV) infusion on Day 1 of infusion Cycles 1-35. Pembrolizumab will be administered as an IV infusion on Day 1 of infusion Cycles 1-35.

Conditions

This trial is treating patients with advanced solid cancers.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

MK-7684-001

More information

Trial Identifiers

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Trial sponsor

Merck

Scientific Title

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

Eligibility

Inclusion

  • For Part A participants enrolled prior to Amendment 7, must have 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 Japanese cohort added with Amendment 7: Must reside in Japan and be of Japanese descent and have adenocarcinoma of the stomach and/or gastric-esophageal junction (GEJ) that is considered inoperable and that has received, and progressed on, at least 1 prior chemotherapy regimen or human epidermal growth factor receptor 2 (HER2)/neu-targeted approved therapy (if HER2/neu-positive). In both cases, participants may be untreated or could have received and progressed on 1 prior regimen, but must not have received prior anti-PD-1/PD-L1 therapy
  • For Part A participants with non-small cell lung cancer (NSCLC) added with Amendment 7: Must have a histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b per current American Joint Committee on Cancer criteria, edition 8) non-squamous NSCLC
  • For Part B China participants added with Amendment 12. Must have a histologically or cytologically confirmed metastatic solid tumor for which no more than 2 prior lines of therapy were administered and there is no available therapy that is expected to convey clinical benefit AND be Chinese from mainland China
  • For Parts A and B: Has histologically or cytologically confirmed metastatic solid tumor
  • Has measurable 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)
  • For Chinese participants enrolled as part of Amendment 12. No tumor tissue samples will be collected

Exclusion

  • 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 providing documented 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
  • For Part A participants with NSCLC added with Amendment 7: Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) other than an aspirin dose ≤1.3 gram per day for a 5-day period (8-day period for long-acting agents, such as piroxicam)
  • For Part A participants with NSCLC added with Amendment 7: Is unable or unwilling to take folic acid or Vitamin B12 supplementation

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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