Clinical Trials /

A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies

NCT03471286

Description:

This is a single-institution, single arm, open label, window of opportunity clinical trial that will act as a Master Protocol with a primary objective to assess pharmacodynamic effects of the novel study drugs in subjects with resectable solid tumor malignancies. Each Sub-protocol conducted under the Master Protocol will evaluate different novel therapeutic agent(s). Estimated enrollment is 15 subjects per Sub-Protocol.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies
  • Official Title: A Phase 1b Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies

Clinical Trial IDs

  • ORG STUDY ID: J17168
  • SECONDARY ID: IRB00156271
  • SECONDARY ID: I-24360-17-13
  • NCT ID: NCT03471286

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
EpacadostatSub-Protocol A

Purpose

This is a single-institution, single arm, open label, window of opportunity clinical trial that will act as a Master Protocol with a primary objective to assess pharmacodynamic effects of the novel study drugs in subjects with resectable solid tumor malignancies. Each Sub-protocol conducted under the Master Protocol will evaluate different novel therapeutic agent(s). Estimated enrollment is 15 subjects per Sub-Protocol.

Detailed Description

      Patients will have a short-course (4-weeks) administration of a given compound in the
      timeframe between the diagnostic biopsy and the surgical resection. A pre-treatment tumor
      biopsy will be obtained, and blood samples will be collected before, during, and at the end
      of treatment.
    

Trial Arms

NameTypeDescriptionInterventions
Sub-Protocol AExperimentalEpacadostat
  • Epacadostat

Eligibility Criteria

        Inclusion Criteria:

          1. Must have biopsy-proven solid tumor that is eligible for elective surgical resection,
             disease does not require immediate therapy, and there is NO approved/ standard therapy
             available that is shown to prolong overall survival.

          2. ECOG performance status of 0 or 1.

          3. Must have a tumor lesion that is amenable to biopsy, and willing to undergo biopsy.

          4. Willing to provide tissue and blood samples for research.

        Exclusion Criteria:

          1. The following solid tumors are NOT eligible: Primary brain tumor, Ocular melanoma,
             Head and neck cancer, Breast cancer, Prostate cancer, Testicular cancer, and Stage III
             rectal cancer.

          2. Any active malignancy within 3 years prior, except: Adequately treated basal cell or
             squamous cell skin cancer, or early stage cancers (carcinoma in situ or stage 1)
             treated with curative intent.

          3. Any uncontrolled intercurrent illness, including but not limited to: Symptomatic
             congestive heart failure, Unstable angina pectoris or coronary angioplasty or stenting
             within 6 months prior to enrollment, Cardiac arrhythmia, Psychiatric illness or social
             situations that would limit compliance with study requirements, or Ongoing or active
             infection.

          4. Any known sensitivity to or history of allergic reaction to compounds of similar
             chemical or biological composition of study drug(s).

          5. Unwilling or unable to follow the study schedule.

        Other protocol defined inclusion/exclusion criteria may apply.
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pharmacodynamic effects as measured by changes in biomarkers in pre- and post-dose tumor and blood specimens
Time Frame:Approximately 1 year
Safety Issue:
Description:To establish baseline levels and measure pharmacodynamic biomarker changes in tumor and/or blood samples after treatment with the study drug. Sub- Protocol A will focus on changes in CD8+ T cells, CD4+Foxp3+ cells, NK cells, DCs and immune checkpoints.

Secondary Outcome Measures

Measure:Safety and tolerability as measured by incidence of AEs (Adverse Events)
Time Frame:Approximately 1 year
Safety Issue:
Description:To assess the safety and tolerability of the study drug in the pre-surgical setting graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Measure:Pathological Response Rate as measured by correlation of biomarkers in tumor and/or blood specimens
Time Frame:Approximately 1 year
Safety Issue:
Description:To evaluate pathological response rate of solid tumor malignancies in subjects receiving neo-adjuvant treatment with the study drug and to assess a possible correlation with biomarkers either in the tumor specimens either in the bloods samples and the pathological response.
Measure:Overall Survival
Time Frame:Approximately 2 years
Safety Issue:
Description:To determine the overall survival (OS) status of subject treated which the study drug at 6 months, 1 year and 2 year

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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