Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

Celldex endeavors to make investigational products available to patients with life-threatening diseases who have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. Requests for expanded access to rindopepimut in patients with EGFRvlll expressing recurrent glioblastoma will be considered.

See also
Status	Clinical Trial	Phase
Terminated	`NCT04681677` - Recurrent GBM Treated With Neurosurgical Resection and IORT Using the Xoft Axxent eBx System and Bevacizumab	Phase 2
Terminated	`NCT04763031` - Recurrent GBM With Maximal Neurosurgical Removal and Treatment With IORT	N/A
Active, not recruiting	`NCT05370508` - A Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Subjects With Recurrent GBM	Phase 1/Phase 2

NCT number	NCT03068650
Study type	Expanded Access
Source	Celldex Therapeutics
Contact
Status	No longer available
Phase	N/A

Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut — CDX-110

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms