Development and Analysis of a Stool Bank for Cancer Patients

NCT04291755 | Recruiting FDA Drug

• 1 other identifier: PB-002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This study is aimed at understanding the impact of gut microbiota on efficacy of cancer therapies, in particular checkpoint inhibitors, and using the resulting information to design microbial immunotherapies. Although animal models are of use to determine the influences of gut and other microbiota on cancer treatment modalities, they are limited due to differences between mouse and human physiology and immunology, as well as the inherent differences in gut microbial populations between the two mammalian organisms. Therefore, samples obtained as donations from human subjects undergoing cancer treatment are of great value for the identification and determination of bacteria and their metabolic processes that are involved in the successful cure and remission of cancer by checkpoint inhibitor therapies. The objective of this study is to collect 3 samples each of blood, urine, and stool in subjects with cancer. This is a non-interventional, 2 site study in 100 people who are undergoing any type of cancer immunotherapy. Subjects who meet the entry criteria will provide 5 samples each of blood, urine, and stool over a 12-month period.

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Colorectal

Keywords

Non-small cell lung cancer; immunotherapy; checkpoint inhibitor; pembrolizumab; nivolumab; ipilimumab; microbiome

Outcome Measures

Primary Outcomes (1)

• Checkpoint inhibitor response

  Response of the tumor to treatment, as evaluated by the iRECIST criteria

  6-12 months

Study Arms (1)

Checkpoint inhibitor therapy

Patients will be administered a checkpoint inhibitor therapy, including but not limited to pembrolizumab, nivolumab, ipilimumab, and atlizumab, at the standard dosing regimen prescribed by their physician. Stool, blood, and urine samples will be collected from patients prior to start of treatment, and at 4 more timepoints over the next 12 months.

Drug: Pembrolizumab Injection

Interventions

Pembrolizumab Injection DRUG

Any checkpoint inhibitor is acceptable

Also known as: nivolumab, ipilimumab, atlizumab

Checkpoint inhibitor therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any person meeting the above criteria

You may qualify if:

• Men or women who are ≥ 18 years old who are undergoing any type of cancer immunotherapy
• Subjects who are able to provide written informed consent

You may not qualify if:

• Subjects with HIV, Hepatitis B, or Hepatitis C
• Subjects without the mental capacity to complete either a written or online questionnaire, alone or with assistance, or make sound decisions
• Women who are pregnant or who plan on becoming pregnant
• Women who are nursing

Sponsors & Collaborators

• Persephone Biosciences: lead
• Pharm-Olam International: collaborator

Study Sites (2)

Compassionate Care Research Group, Inc.

Fountain Valley, California, 92708, United States

RECRUITING

Bond and Steele Clinic, P.A.

Winter Haven, Florida, 33881, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool, blood, and urine specimens from each patient

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms

Interventions

pembrolizumab; Nivolumab; Ipilimumab; tocilizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Study Coordinator

CONTACT

858-682-4777; support@persephonebiome.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: June 28, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)