Biomarkers For Immune Checkpoint Inhibitors

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04204434
Study type	Observational [Patient Registry]
Source	Rhode Island Hospital
Contact	Andrew Schumacher, MSHCE
Phone	401-444-3234
Email	aschumacher@lifespan.org
Status	Recruiting
Phase
Start date	November 29, 2016
Completion date	September 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03826043` - THrombo-Embolic Event in Onco-hematology	N/A
Terminated	`NCT03166631` - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread	Phase 1
Completed	`NCT01938846` - BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors	Phase 1
Recruiting	`NCT06058312` - Individual Food Preferences for the Mediterranean Diet in Cancer Patients	N/A
Completed	`NCT03308942` - Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants	Phase 2
Recruiting	`NCT06018311` - Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads	N/A
Withdrawn	`NCT05431439` - Omics of Cancer: OncoGenomics
Completed	`NCT01343043` - A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma	Phase 1
Completed	`NCT01938638` - Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer	Phase 1
Recruiting	`NCT05514444` - Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)	Phase 1
Recruiting	`NCT02292641` - Beyond TME Origins	N/A
Terminated	`NCT00954512` - Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)	Phase 1/Phase 2
Recruiting	`NCT04958239` - A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors)	Phase 1
Recruiting	`NCT04627376` - Multimodal Program for Cancer Related Cachexia Prevention	N/A
Completed	`NCT01222728` - Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
Recruiting	`NCT06004440` - Real World Registry for Use of the Ion Endoluminal System
Active, not recruiting	`NCT05636696` - COMPANION: A Couple Intervention Targeting Cancer-related Fatigue	N/A
Not yet recruiting	`NCT06035549` - Resilience in East Asian Immigrants for Advance Care Planning Discussions	N/A
Recruiting	`NCT06004466` - Noninvasive Internal Jugular Venous Oximetry
Completed	`NCT03190811` - Anti-PD-1 Alone or Combined With Autologous DC-CIK Cell Therapy in Advanced Solid Tumors	Phase 1/Phase 2