A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

Active:	Yes
Cancer Type:	Head and Neck Cancer	NCT ID:	NCT01772004
Trial Phases:	Phase I	Protocol IDs:	EMR 100070-001 (primary) 2013-002834-19
Eligibility:	18 and over, Male and Female	Study Type:	Biomarker/Laboratory analysis Treatment
Study Sponsor:	EMD Serono, Incorporated
NCI Full Details:	http://clinicaltrials.gov/show/NCT01772004

Summary

This is a Phase 1, open-label, dose-escalation trial of avelumab [antibody targeting programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in subjects with selected tumor indications. New recruitment is open for all active cohorts.

Active cohorts: gastric/gastroesophageal junction (GEJ, first line switch maintenance and second line), melanoma, castrate-resistant prostate cancer (CRPC), adrenocortical carcinoma (ACC), mesothelioma, non-small cell lung cancer (NSCLC, first line), urothelial carcinoma (efficacy), gastric/GEJ (third line), ovarian cancer (secondary), ovarian cancer (platinum refractory + liposomal doxorubicin), renal cell carcinoma (RCC, first and second line) and head and neck squamous cell carcinoma (HNSCC).

Closed cohorts: NSCLC (post-platinum), metastatic breast cancer (MBC), colorectal cancer (CRC), and urothelial carcinoma (secondary).

Treatment Sites in Georgia

Augusta University Medical Center
1120 15th Street
Augusta, GA 30912
706-721-4430
www.augustahealth.org

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