Solid Tumor
A Phase I, Open-label, Multiple-Ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of MSB0010718C, a Monoclonal Anti-PD-L1 Antibody, in Adults With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications
NCI-13-C-0063, NCT01772004
Print this page 
Investigator(s): |
James L. Gulley, M.D., Ph.D., F.A.C.P.
Senior Investigator
Phone: 301-435-2956
gulleyj@mail.nih.gov
|
|
|
|
Laura D. Otten, R.N., B.S.N., O.C.N.
Medical Oncology Referral Coordinator
Phone: 301-451-1228
1-866-611-6310 (Toll Free)
Fax: 301-480-0919
ottenl@mail.nih.gov
|
Mary Pazdur, M.S.N., C.R.N.P
Research Nurse Practitioner
Phone: 301-496-7870
pazdurm@mail.nih.gov
|
|
| |
Key Eligibility Criteria:
- Histologically or cytologically proven metastatic or locally advanced solid tumor for which no standard therapy exists or standard therapy has failed (dose-escalation phase)
- Histologically or cytologically proven metastatic castrate resistant prostate cancer, metastatic colorectal cancer, recurrent or refractory lung cancer, unresectable melanoma, or refractory or recurrent ovarian cancer (expansion phase)
- ≥ 18 years of age
- ECOG: 0-1
- Measurable disease with at least 1 uni-dimensional measurable lesion by RECIST 1.1
- Adequate organ function as defined by liver, kidney, and hematologic laboratory testing
- No uncontrolled significant acute or chronic infection or history of stem cell, organ transplant, or immune deficiency
- No systemic autoimmune disease requiring treatment for more than 30 days in the last 3 years
- No intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
- Not pregnant or breastfeeding
Study Outline:
- Screening with physical examination, blood samples, and imaging studies to determine eligibility for the study
- MSB0010718C is administered by intravenous infusion (through a vein) over one hour every 2 weeks
- Participants will continue to receive MSB0010718C every 2 weeks as long the tumor does not start growing again and there are no serious side effects
- Participants will be monitored with blood tests and imaging studies while on the study
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed:
Updated: 2/12/13
Back to Top
