A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors
18 Years
N/A
Both
Advanced Malignant Melanoma, Renal Cell Carcinoma, Non-small Cell Lung Cancer, Colorectal Cancer
Trial Information
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors
Inclusion Criteria:
- In the dose-escalation phase: histologically- or cytologically- confirmed advanced
malignant melanoma, renal cell carcinoma, non-small cell lung cancer, or colorectal
cancer that is refractory to standard therapy and for which no standard therapy
exists.
- In the dose-expansion phase: histologically- or cytologically- confirmed advanced
malignant melanoma, colorectal cancer, or non-small cell lung cancer that is
refractory to standard therapy and for which no standard therapy exists.
- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
- Adequate organ and marrow function.
- Subjects must have at least 1 measurable lesion.
- Available archived tumor tissue sample.
- Willingness to provide consent for biopsy samples .
Exclusion Criteria:
- Any prior Grade ≥ 3 irAE while receiving immunotherapy
- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
- Active or prior documented autoimmune disease within the past 2 years
- History of primary immunodeficiency
- Symptomatic or untreated central nervous system (CNS) metastases requiring concurrent
treatment
- Women who are pregnant or lactating
- Uncontrolled intercurrent illness
- Known history of tuberculosis
- Known to be human immunodeficiency virus (HIV) positive
- Hepatitis A, B or C infection
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of participants experiencing dose-limiting toxicities, adverse events (AEs), serious adverse events (SAEs).
Outcome Description:
MTD or OBD will be determined by the number of participants experiencing dose-limiting toxicities. Safety profile will be assessed through number of participants experiencing adverse events (AEs), serious adverse events (SAEs), laboratory evaluations, vital signs, and physical examinations.
Outcome Time Frame:
90 days after the last dose of MEDI4736
Safety Issue:
Yes
Principal Investigator
Ramy Ibrahim, MD
Investigator Role:
Study Director
Investigator Affiliation:
MedImmune LLC
Authority:
United States: Food and Drug Administration
Study ID:
CD-ON-MEDI4736-1108
NCT ID:
NCT01693562
Start Date:
September 2012
Completion Date:
December 2015
Related Keywords:
- Advanced Malignant Melanoma
- Renal Cell Carcinoma
- Non-Small Cell Lung Cancer
- Colorectal Cancer
- Advanced malignant melanoma
- Renal cell carcinoma
- Non-small cell lung cancer
- Colorectal cancer
- MEDI4736
- Advanced solid tumors
- B7-H1
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Renal Cell
- Colorectal Neoplasms
- Lung Neoplasms
- Melanoma
Name | Location |
|---|---|
| Research Site | Boca Raton, Florida |
| Research Site | Albany, Georgia |
| Research Site | Albany, New York |
