Completed PHASE3 INTERVENTIONAL 2-arm NCT01480479

Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma (ACT IV)

An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma

Sponsor: Celldex Therapeutics

Conditions Giant Cell Glioblastoma Glioblastoma Glioblastoma With Oligodendroglial Component Gliosarcoma Small Cell Glioblastoma

Interventions KLH Rindopepimut (CDX-110) with GM-CSF Temozolomide

Updated 11 times since 2017 Last updated: Jan 11, 2018 Started: Nov 30, 2011 Primary completion: Nov 30, 2016 Completion: Nov 30, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Giant Cell Glioblastoma and Glioblastoma and is currently completed. Celldex Therapeutics leads this study, which shows 11 recorded versions since 2011 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

11 versions recorded

Dec 2025 — Present [monthly]

Completed PHASE3
Oct 2025 — Dec 2025 [monthly]

Completed PHASE3
Sep 2025 — Oct 2025 [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3

▶ Show 6 earlier versions

Apr 2022 — Jul 2024 [monthly]

Completed PHASE3
Jan 2021 — Apr 2022 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2018 — Jun 2018 [monthly]

Completed PHASE3
Feb 2017 — Feb 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Nov 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Celldex Therapeutics

Data source: Celldex Therapeutics

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aarau, Switzerland , Adelaide, Australia , Allentown, United States , Amherst, United States , Amphoe Muang, Thailand , Amsterdam, Netherlands , Andheri-West, India , Angers, France , Ann Arbor, United States , Annapolis, United States and 191 more locations