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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

Status
Active
Cancer Type
Kidney Cancer
Trial Phase
Phase I
Eligibility
18 and over, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCT ID
NCT01772004
Protocol IDs
EMR 100070-001 (primary)
2013-002834-19
Study Sponsor
EMD Serono, Incorporated

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

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.