Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Carcinoma

Lung Neoplasms

Triple Negative Breast Neoplasms

Urinary Bladder Neoplasms

Carcinoma, Renal Cell

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Kidney Neoplasms

Kidney Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Cohort A includes patients with microsatellite stable (MSS) colorectal cancer (CRC). Patients will receive a 14 day run-in of EDP1503 alone, following which they will be treated with a combination of EDP1503 and pembrolizumab.

Cohort B includes patients with Triple Negative Breast Cancer (TNBC). Patients will receive a 14 day run-in of EDP1503 alone, following which they will be treated with a combination of EDP1503 and pembrolizumab.

Cohort C includes patients with non-small-cell lung cancer (NSCLC), bladder cancer; gastroesophageal (GE) cancer, any microsatellite unstable, or renal cell carcinoma (RCC) who are relapsed to prior PD-1/L1 therapy. Patients will receive a 14 day run-in of EDP1503 alone, following which they will be treated with a combination of EDP1503 and pembrolizumab.

4 capsules taken by mouth twice daily. Each capsule will contain ≥ 7.5x10\^10 colony-forming units (CFU)

EDP1503

200 mg given by intravenous (IV) infusion once every 3 weeks

Johanna Bendell, MD

This study is being conducted to assess the safety, tolerability, and efficacy of EDP1503 alone and in combination with pembrolizumab in patients with advanced metastatic colorectal carcinoma, triple-negative breast cancer, and checkpoint inhibitor relapsed tumors

This will be a Phase I open-label study which will involve a 2-week monotherapy with EDP1503, following which the patients will be dosed with a combination of EDP1503 and pembrolizumab.

Patients will be assigned to one of three cohorts based on disease condition: Cohort A (microsatellite stable colorectal cancer); Cohort B (Triple negative breast cancer); Cohort C (PD-1 relapsed tumors: non small cell lung cancer, gastroesophageal cancer, or any microsatellite unstable or renal cell carcinoma). Patients will receive monotherapy with EDP1503 for a period of 2 weeks, following which they will be dosed with a combination of EDP1503 and pembrolizumab.

A Study of EDP1503 in Patients With Colorectal Cancer, Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors

A Phase I Open-label Study of EDP1503 Alone and in Combination With Pembrolizumab in Patients With Advanced Metastatic Colorectal Carcinoma, Triple-negative Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors

Number of participants with EPD1503 related adverse events as assessed per CTCAE v5.0

Safety and tolerability of EDP1503 alone and in combination with pembrolizumab assessed via clinical laboratory evaluations

To determine preliminary evidence of anti-tumor activity of EDP1503 in patients

SCRI Development Innovations, LLC

Merck Sharp & Dohme LLC

Evelo Biosciences, Inc.

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Neuroendocrine Tumor

Neuroepithelioma

Antibodies

Immunoglobulins

Participants that have not received prior anti-PD1 therapy for their cancer will be enrolled to this arm.

Participants that have received prior anti-PD1 therapy for their cancer will be enrolled to this arm.

200 mg given by intravenous (IV) infusion once every 3 weeks.

Taken by mouth twice daily. Each capsule will contain ≥ 7.5x10\^10 colony-forming units (CFU).

Jason Luke, MD

This study is being done to determine if orally administered EDP1503 will enhance the response to standard immunotherapy treatment (pembrolizumab) in participants with advanced melanoma.

The study will involve initial administration of EDP1503 for a run-in period (2 weeks) followed by administration of both EDP1503 (twice daily) and pembrolizumab (every 3 weeks).

Mandatory biopsies are required before starting study treatment and after 2 weeks of EDP1503 dosing.

Pembrolizumab and EDP1503 in Advanced Melanoma

Phase II Dual-Cohort Study Evaluating the Effects of Pembrolizumab in the Presence of Gut Microbiota Modulation With EDP1503 in Advanced Melanoma Naïve or Refractory to Anti-PD1 Antibody

University of Chicago

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of EDP1503 in Patients With Colorectal Cancer, Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors	NCT03775850	Colorectal Canc... Triple Negative... Non Small Cell ... Bladder Cancer GastroEsophagea... Renal Cell Carc... MSI-H	EDP1503 Pembrolizumab	18 Years -	Evelo Biosciences, Inc.
A Study of EDP1503 in Patients With Colorectal Cancer, Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors	NCT03775850	Colorectal Canc... Triple Negative... Non Small Cell ... Bladder Cancer GastroEsophagea... Renal Cell Carc... MSI-H	EDP1503 Pembrolizumab	18 Years -	Evelo Biosciences, Inc.
Pembrolizumab and EDP1503 in Advanced Melanoma	NCT03595683	Melanoma (Skin) Melanoma	Pembrolizumab EDP1503	18 Years -	University of Chicago
A Study of EDP1503 in Patients With Colorectal Cancer, Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors	NCT03775850	Colorectal Canc... Triple Negative... Non Small Cell ... Bladder Cancer GastroEsophagea... Renal Cell Carc... MSI-H	EDP1503 Pembrolizumab	18 Years -	Evelo Biosciences, Inc.

Spots Global Cancer Trial Database for edp1503

Every month we try and update this database with for edp1503 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for edp1503

Every month we try and update this database with for edp1503 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for edp1503 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.