A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies
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|ClinicalTrials.gov Identifier: NCT03471286|
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : June 14, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: Epacadostat||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 6, 2019|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2023|
Experimental: Sub-Protocol A
Drug is taken orally two times per day for 28 days, prior to surgical resection of tumor.
- Pharmacodynamic effects as measured by changes in biomarkers in pre- and post-dose tumor and blood specimens [ Time Frame: Approximately 1 year ]
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.
- Safety and tolerability as measured by incidence of AEs (Adverse Events) [ Time Frame: Approximately 1 year ]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.
- Pathological Response Rate as measured by correlation of biomarkers in tumor and/or blood specimens [ Time Frame: Approximately 1 year ]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.
- Overall Survival [ Time Frame: Approximately 2 years ]To determine the overall survival (OS) status of subject treated which the study drug at 6 months, 1 year and 2 year
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471286
|Contact: Denise Gallagher, RNfirstname.lastname@example.org|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Nilofer Azad, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|