A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects with Advanced Solid Tumors

MedImmune0 sites1,322 target enrollmentAugust 15, 2013

Overview

No summary available.

Registry

who.int

Start Date

August 15, 2013

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Written informed consent.
•Dose\-escalation phase: histologically\-or cytologically\- confirmed
•advanced 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.
•Dose\-expansion phase: histologically\-or cytologically\-confirmed
•advanced utaneous melanoma, uveal melanoma, HCC, SCCHN, NSCLC squamous and non\-squamous, gastroesophageal cancer, TNBC, or pancreatic adenocarcinoma, urothelial bladder cancer, GBM, epithelial ovarian cancer, soft tissue sarcoma, SCLC, MSI\-high cancers, HPV\-positive cancers, or nasopharyngeal carcinoma.
•HCC subjects must be of Child\-Pugh class A (not amenable to or
•refractory to locoregional therapy). Subjects with HCC associated with hepatitis B virus must be receiving adequate antiviral therapy.
•Subjects with histologically or cytologically confirmed inoperable or metastatic transitional cell carcinoma of the urothelium (subjects must have received and have progressed or are refractory to at least 1 but not more than 2 prior lines of systemic therapy for inoperable or metastatic disease)
•Subjects with histologically or cytologically documented NSCLC must
•present with Stage IIIB/ Stage IV disease, or with recurrent or progressive disease following multimodal therapy for locally advanced disease (refer to protocol for further details).

•Concurrent enrollment in another clinical study, unless it is an
•observational (non\-interventional) clinical study or the follow\-up period of an interventional study.
•Receipt of any immunotherapy, BRAF inhibitor (in cutaneous melanoma and uveal melanoma subjects), or investigational anticancer therapy within 4 weeks prior to the first dose of MEDI4736; in the case of MAbs, 6 weeks prior to the first dose of
•Any prior Grade \= 3 irAE while receiving immunotherapy.
•For all subjects: prior exposure to any anti\-PD\-1 or anti\-PD\-L1 antibody.
•For UBC cohort: prior treatment with immunotherapy agents including, but not limited to, tumor necrosis factor receptor superfamily agonists or checkpoint inhibitors or natural killer (NK) cell inhibitors including agents targeting KIR, PD\-1, PD\-L1, CTLA\-4, OX40, CD27, CD137 (4\-1BB), CD357 (GITR), and CD40\. Prior treatment with Bacillus Calmette\-Guerin therapy is permitted.
•Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
•Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736\.
•Active or prior documented autoimmune disease within the past 2 years
•NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.