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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|