NCT01860638

A Comparison of Continuous Bevacizumab (Avastin) Treatment or Placebo in Addition to Lomustine Followed by Standard of Care After Disease Progression in Participants With Glioblastoma

Completed Phase 2 Last updated 30 April 2018

What this trial tests

Phase 2 trial testing Bevacizumab in Glioblastoma in 296 participants. Completed in 5 May 2017.

Timeline

19 August 2013

Primary endpoint
13 January 2017

5 May 2017

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	296
Start date	19 August 2013
Primary completion	13 January 2017
Estimated completion	5 May 2017
Sites	64 locations across France, Italy, Greece, Austria, Sweden, Estonia, United Kingdom, Romania

Drugs / interventions tested

• Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
• Lomustine (LOMUSTINE) — full drug profile →
• Placebo
• Radiotherapy
• Temozolomide (temozolomide) — full drug profile →
• SOC Agent — full drug profile →

Conditions studied

• Glioblastoma — all drugs for Glioblastoma →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This multicenter, double-blind, placebo-controlled, randomized study will evaluate the efficacy and safety of the addition of bevacizumab treatment to lomustine (in 2nd-line \[2L\] treatment) and SOC (in 3rd-line \[3L\] and subsequent lines of treatment) following first-line disease progression (PD1) in participants with newly diagnosed glioblastoma. All enrolled participants will receive 1L treatment with radiotherapy, temozolomide, and bevacizumab. At PD1, eligible participants will be randomized (1:1) to receive 2L treatment with either bevacizumab plus lomustine or placebo plus lomustine. After second-line disease progression (PD2), participants will receive 3L treatment and will continue blinded bevacizumab or placebo with the addition of an SOC agent. Following third-line disease progression (PD3), participants will receive subsequent lines of treatment and will either continue blinded bevacizumab or placebo (at the discretion of the investigator), or switch to open-label bevacizumab (at the choice of the participant).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treatment options for progression or recurrence of glioblastoma: a network meta-analysis.
   McBain C, Lawrie TA, Rogozińska E, Kernohan A, et al · · 2021 · cited 105× · PMID 34559423 · DOI 10.1002/14651858.cd013579.pub2
2. A Systematic Review of Glioblastoma-Targeted Therapies in Phases II, III, IV Clinical Trials.
   Cruz Da Silva E, Mercier MC, Etienne-Selloum N, Dontenwill M, et al · · 2021 · cited 99× · PMID 33918704 · DOI 10.3390/cancers13081795
3. Practical management of bevacizumab-related toxicities in glioblastoma.
   Brandes AA, Bartolotti M, Tosoni A, Poggi R, et al · · 2015 · cited 75× · PMID 25568148 · DOI 10.1634/theoncologist.2014-0330
4. Immune Checkpoints and Innovative Therapies in Glioblastoma.
   Romani M, Pistillo MP, Carosio R, Morabito A, et al · · 2018 · cited 70× · PMID 30406030 · DOI 10.3389/fonc.2018.00464
5. A Randomized Phase II Trial (TAMIGA) Evaluating the Efficacy and Safety of Continuous Bevacizumab Through Multiple Lines of Treatment for Recurrent Glioblastoma.
   Brandes AA, Gil-Gil M, Saran F, Carpentier AF, et al · · 2019 · cited 50× · PMID 30266892 · DOI 10.1634/theoncologist.2018-0290
6. Angiogenesis in Glioblastoma-Treatment Approaches.
   Nowacka A, Śniegocki M, Smuczyński W, Bożiłow D, et al · · 2025 · cited 20× · PMID 40136656 · DOI 10.3390/cells14060407
7. Targeted Glioma Therapy-Clinical Trials and Future Directions.
   Shikalov A, Koman I, Kogan NM. · · 2024 · cited 19× · PMID 38258110 · DOI 10.3390/pharmaceutics16010100
8. Current state of immune checkpoints therapy for glioblastoma.
   Wang H, Yang J, Li X, Zhao H. · · 2024 · cited 18× · PMID 38298707 · DOI 10.1016/j.heliyon.2024.e24729