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Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)


Active: No
Cancer Type: Adrenal Cancer
Breast Cancer
Colon/Rectal Cancer
Head and Neck Cancer
Kidney Cancer
Lung Cancer
Melanoma
Mesothelioma
Ovarian Cancer
Prostate Cancer
Retroperitoneal Tumors
Stomach/ Gastric Cancer
NCT ID: NCT01772004
Trial Phases: Phase I Protocol IDs: EMR 100070-001 (primary)
2013-002834-19
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: EMD Serono Research & Development Institute, Inc.
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
participants with selected tumor indications. New recruitment is open for all active cohorts.

Active cohorts: Escalation revised dosing regimen cohort.

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