Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

A Study of BMS-986156 Given Alone and in Combination With Nivolumab in Subjects With Advanced Solid Tumors

Protocol: OSU-16195

Full Title

A Phase I/IIa Dose Escalation and Cohort Expansion Study for Safety,Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination with Nivolumab (BMS-936558, anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors

Purpose

The purpose of this study is to evaluate the safety, tolerability pharmacokinetics,

pharmacodynamics, immunogenicity and preliminary anti-tumor activity of BMS-986156 when

administered alone and in combination with nivolumab in subjects with advanced solid tumors.

Are you eligible?

Inclusion Criteria:

For Dose Escalation:

Subjects with any previously treated advanced (metastatic or refractory) solid

tumor

For Cohort Expansion:

Subjects must have a previously treated advanced solid tumor to be eligible

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy

Women of child-bearing potential and men must use an acceptable method of

contraception during treatment and for 23 weeks after treatment for women and 31

weeks for men

Exclusion Criteria:

Known central nervous system metastases or central nervous system as the only source

of disease

Other concomitant malignancies (with some exceptions per protocol)

Active, known or suspected autoimmune disease

Uncontrolled or significant cardiovascular disease

History of active or chronic hepatitis (e.g. Hep B or C)

Impaired liver or bone marrow function

Major surgery less than 1 month before start of the study

Brain Cancer Genitourinary Cancers Endocrine Cancers Gastrointestinal Cancers Gynecologic Cancers Bone Cancer Head & Neck Cancers Skin Cancers Sarcoma Lung Cancers Vulvar Cancer Anal Cancer Pituitary Tumor Liver Cancer Merkel Cell Carcinoma Cervical Cancer Squamous Cell Carcinoma Neuroendocrine Cancer Endometrial Cancer Testicular Cancer Stomach (Gastric) Cancer Esophageal Cancer Bone & Spine Sarcoma Soft Tissue Sarcoma Laryngeal Cancer Skull Base Tumors Colon Cancer Small Intestine Cancer Oropharyngeal Cancer Bladder Cancer Parathyroid Cancer Pancreatic Cancer Kidney Cancer Ovarian Cancer Myelodysplastic Syndrome Thrombotic Thrombocytopenic Purpura Breast Cancer Vaginal Cancer Lip & Oral Cavity Cancer Rectal Cancer Gliomas Basal Cell Carcinoma Melanoma Thyroid Cancer Other Brain Cancers Prostate Cancer Gallbladder Cancer Kaposi Sarcoma Spine Tumors Gastrointestinal Carcinoid Tumors