Recruiting

Observational Study

Sponsor:

Persephone Biosciences

Code:

NCT04291755

Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma, Colorectal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab Injection

Study Details

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

Study ID

NCT04291755

Start date

Jun 28, 2019

Status verified date

Apr, 2024

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Pembrolizumab Injection

Any checkpoint inhibitor is acceptable

Primary outcome measure

  • Checkpoint inhibitor response [ Time Frame: 6-12 months ]

Central Contacts and Locations

Central contacts

Study Coordinator

858-682-4777support@persephonebiome.com

Locations

Compassionate Care Research Group, Inc.

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Esther Jayachandran

714-338-2154esther@compcareresearch.com

Principal Investigator:

Derrick Su, MD

Bond and Steele Clinic, P.A.

Recruiting

Winter Haven, Florida, United States, 33881

Contacts

Nikki Denmark

863-293-1191ndenmark@bondclinic.com

Principal Investigator:

Osama Hlalah, MD

More Information

Sponsor

Persephone Biosciences

Last update posted

Apr 5, 2024

Last verified

Apr, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Persephone Biosciences on 2024-04-05.