NCT03430947: RadioCoBRIM

Vemurafenib Plus Cobimetinib After Radiosurgery in Patients With BRAF-mutant Melanoma Brain Metastases

Terminated Phase 2 Last updated 14 September 2023

What this trial tests

Phase 2 trial testing Vemurafenib in Malignant Melanoma Stage IV in 20 participants. Terminated before completion.

Timeline

1 July 2018

Primary endpoint
10 February 2023

10 February 2023

Quick facts

Lead sponsor	Technische Universität Dresden
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 July 2018
Primary completion	10 February 2023
Estimated completion	10 February 2023
Sites	3 locations across Germany

Drugs / interventions tested

• Vemurafenib (vemurafenib) — full drug profile →
• Cobimetinib (cobimetinib) — full drug profile →

Conditions studied

• Malignant Melanoma Stage IV — all drugs for Malignant Melanoma Stage IV →
• BRAF V600 Mutation — all drugs for BRAF V600 Mutation →
• Brain Metastases — all drugs for Brain Metastases →

Sponsor

Technische Universität Dresden — full company profile →

Who can join

18 and older, any sex, with Malignant Melanoma Stage IV or BRAF V600 Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase II, open label, non-randomised study of vemurafenib and cobimetinib after radiosurgery in adult patients with BRAFV600-mutant melanoma brain metastases. All patients will receive vemurafenib 960 mg twice a day on days 1 - 28 combined with cobimetinib 60 mg once a day on days 1 - 21 of each 28-day treatment cycle until disease progression, drug toxicity or death.

The primary objective of this study is to determine the best overall response rate (BORR) in the brain. The extracranial BORR, intra- and extracranial duration of response, progression-free survival and overall survival, adverse events, quality of life and radiomics features predicting long-term local control of brain metastases and treatment-related toxicity will also be examined.

Publications & conference data

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

1. Melanoma central nervous system metastases: An update to approaches, challenges, and opportunities.
   Eroglu Z, Holmen SL, Chen Q, Khushalani NI, et al · · 2019 · cited 34× · PMID 30712316 · DOI 10.1111/pcmr.12771
2. Onco-immunomodulatory properties of pharmacological interference with RAS-RAF-MEK-ERK pathway hyperactivation.
   Avery TY, Köhler N, Zeiser R, Brummer T, et al · · 2022 · cited 31× · PMID 35965494 · DOI 10.3389/fonc.2022.931774
3. Integration of Systemic Therapy and Stereotactic Radiosurgery for Brain Metastases.
   Tonse R, Tom MC, Mehta MP, Ahluwalia MS, et al · · 2021 · cited 30× · PMID 34359583 · DOI 10.3390/cancers13153682
4. Medical management of brain metastases.
   Lauko A, Rauf Y, Ahluwalia MS. · · 2020 · cited 30× · PMID 32793881 · DOI 10.1093/noajnl/vdaa015
5. Melanoma Brain Metastases in the Era of Target Therapies: An Overview.
   Becco P, Gallo S, Poletto S, Frascione MPM, et al · · 2020 · cited 29× · PMID 32575838 · DOI 10.3390/cancers12061640
6. Current Treatment Approaches and Global Consensus Guidelines for Brain Metastases in Melanoma.
   Tan XL, Le A, Lam FC, Scherrer E, et al · · 2022 · cited 13× · PMID 35600355 · DOI 10.3389/fonc.2022.885472
7. Medical Needs and Therapeutic Options for Melanoma Patients Resistant to Anti-PD-1-Directed Immune Checkpoint Inhibition.
   Hassel JC, Zimmer L, Sickmann T, Eigentler TK, et al · · 2023 · cited 12× · PMID 37444558 · DOI 10.3390/cancers15133448
8. Melanoma Brain Metastases: A Retrospective Analysis of Prognostic Factors and Efficacy of Multimodal Therapies.
   Internò V, Sergi MC, Metta ME, Guida M, et al · · 2023 · cited 12× · PMID 36900333 · DOI 10.3390/cancers15051542