An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma
Trial ID or NCT#
NCT02253992
Status
NOT RECRUITING
Purpose
The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.
Official Title
A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Tolerability of Urelumab Administered in Combination With Nivolumab in Advanced/Metastatic Solid Tumors and B-cell Non-Hodgkins Lymphoma
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - For Dose Escalation: - Subjects with any previously treated advanced (metastatic or refractory) solid tumor type and B-cell non-Hodgkin lymphoma - For Cohort Expansion: - Subjects must have a previously treated advanced solid tumor or B cell non-Hodgkin's lymphoma to be eligible - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - For certain subjects, 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 hepatitis (B or C) - History of active or latent tuberculosis
Investigator(s)
Bernice Kwong, MD
Dermatologist,
Dermatologic oncologist,
Cutaneous oncology specialist,
Dermato-oncology specialist,
Dermatopathologist
Clinical Professor, Dermatology
Sunil Arani Reddy
Medical oncologist,
Cutaneous oncology specialist
Clinical Associate Professor, Medicine - Oncology
Susan M. Swetter, MD
Dermatologist,
Dermatologic oncologist,
Cutaneous oncology specialist,
Melanoma specialist
Professor of Dermatology
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov
