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A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Malignant Melanoma, Renal Cell Carcinoma, Non-small Cell Lung Cancer, Colorectal Cancer

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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 SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteAlbany, New York