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Biomarkers For Immune Checkpoint Inhibitors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04204434
Recruitment Status : Recruiting
First Posted : December 19, 2019
Last Update Posted : May 20, 2022
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
Rhode Island Hospital

Brief Summary:
This is a laboratory, non-treatment study. Immune checkpoint inhibitors are a type of immunotherapy that stimulates a patients immune system to fight their cancer. Immune checkpoint inhibitors are standard, FDA approved treatment for certain types of cancers such as melanoma, lung cancer, kidney cancer and bladder cancer. The laboratories of Dr. Jack Elias and Dr. Chun Geun Lee at Brown University are studying how immune checkpoint inhibitors work.Kintai Therapeutics is a biotech company in Cambridge Massachusetts that will focus on the molecules present in the GI tract, including the stomach, small intestine and colon.

Condition or disease
Advanced Cancer Neoplasms

Detailed Description:
Patients who are receiving immune checkpoint inhibitors for their cancer treatment are eligible. Patients will sign informed consent. Ten cc of blood will be drawn before beginning immune checkpoint inhibitors and 10 cc of blood will be drawn 1-4 months after treatment is initiated. Deidentitified blood samples will be sent to the lab of Dr. Jack Elias and Dr. Chun Geul Lee and analyzed for biomarkers. The blood samples will be linked to the patient by a research number. Response to treatment will be correlated to potential biomarkers. The stool samples will be linked to the patient by a research number. Bacterial DNA and RNA may be sequenced and data used to identify bacterial taxa and genes within the stool. In compliance with NIH guidelines, all human DNA data would be removed computationally, and will not be used in any analyses. Small molecules may be profiled with metabolomics. Bacteria may also be isolated from the stool into in vitro culture, and efficacy of single-strains or communities and/or their DNA, RNA, and metabolites on disease models may be assessed.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Biomarkers For Immune Checkpoint Inhibitors
Actual Study Start Date : November 29, 2016
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2024



Primary Outcome Measures :
  1. To determine serum predictors of response to immune checkpoint inhibitors at study entry, prior to checkpoint inhibitor therapy [ Time Frame: At study entry, prior to checkpoint inhibitor therapy Anytime between 6-12 weeks after initiating treatment. ]
    Measure biomarker levels of immune checkpoint inhibitors in blood serum

  2. To determine serum predictors of response to immune checkpoint inhibitors 4-weeks after initiation of treatment [ Time Frame: Within 4 weeks after initiation of treatment ]
    Measure biomarker levels of immune checkpoint inhibitorsin blood serum

  3. To determine serum predictors of response to immune checkpoint inhibitors anytime between 6-12 weeks after initiating treatment. [ Time Frame: 6-12 weeks after initiating treatment ]
    Measure biomarker levels of immune checkpoint inhibitors in blood serum


Secondary Outcome Measures :
  1. To evaluate bacteria, and bacterial products in gut microbiome before and after treatment with immune checkpoint inhibitors and correlate to response and toxicity. [ Time Frame: At study entry, prior to immune checkpoint inhibitor therapy ]
    Measure bacteria and bacterial products in gut micobiome

  2. To evaluate bacteria, and bacterial products in gut microbiome before and after treatment with immune checkpoint inhibitors and correlate to response and toxicity. [ Time Frame: Within 4 weeks after initiation of treatment ]
    Measure bacteria and bacterial products in gut micobiome

  3. To evaluate bacteria, and bacterial products in gut microbiome before and after treatment with immune checkpoint inhibitors and correlate to response and toxicity. [ Time Frame: Anytime between 6-12 weeks after initiating treatment. ]
    Measure bacteria and bacterial products in gut micobiome


Biospecimen Retention:   Samples With DNA
Stool, tissue, blood, and plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with an advanced solid cancer prior to initiating treatment with an immune checkpoint inhibitor are eligible.
Criteria

Inclusion Criteria:

  • Patients with advanced solid tumors initiating treatment with an immune checkpoint inhibitor.
  • No prior immune checkpoint inhibitors
  • Age >18.
  • Signed informed consent

Exclusion Criteria:

  • The patient is unwilling or unable to provide informed consent

Information from the National Library of Medicine

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): NCT04204434


Contacts
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Contact: Andrew Schumacher, MSHCE 401-444-3234 aschumacher@lifespan.org
Contact: Alise K Lombardo, BS, CCRP 401-444-8856 alombardo@lifespan.org

Locations
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United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Andrew Schumacher, MSHCE    401-444-3234    aschumacher@lifespan.org   
Contact: Alise Lombardo, BS    401-444-8856    alombardo@lifespan.org   
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Andrew Schumacher, MSHCE    401-444-3234    aschumacher@lifespan.org   
Contact: Alise Lombardo, BS    401-444-8856    alombardo@lifespan.org   
Sponsors and Collaborators
Rhode Island Hospital
Brown University
Investigators
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Principal Investigator: Howard Safran, MD Rhode Island Hospital
Publications of Results:
Other Publications:
Doi T, Piha-Paul SA, Jalal SI, et al. Pembrolizumab (MK-3475) for patients with advanced esophageal carcinoma: Preliminary results from KEYNOTE-028.J Clin Oncol 33, 2015 (suppl; abstr 4010).
Le D, Bendell JC, Calvo E, et al. Safety and activity of nivolumab monotherapy in advanced and metastatic (A/M) gastric or gastroesophageal junction cancer (GC/GEC): Results from the CheckMate-032 study. J Clin Oncol 34; 2016 (supp; abstr 06).

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Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT04204434    
Other Study ID Numbers: Biomarkers For I.C. Inhibitors
First Posted: December 19, 2019    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rhode Island Hospital:
Cancer
Advanced
Solid Tumor
Advanced Solid Tumor