NCT05289856

Cabozantinib in Combination With Avelumab in Patients Refractory to Standard Chemotherapy With Advanced Neuroendocrine Neoplasias G3 (NEN G3)

Status unknown Phase 2 Last updated 7 March 2024

What this trial tests

Phase 2 trial testing combination of Avelumab and Cabozantinib in Cancer in 30 participants. Status unknown.

Timeline

28 March 2022

Primary endpoint
1 March 2025

1 December 2025

Quick facts

Lead sponsor	Johannes Gutenberg University Mainz
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	28 March 2022
Primary completion	1 March 2025
Estimated completion	1 December 2025
Sites	2 locations across Germany

Drugs / interventions tested

• combination of Avelumab and Cabozantinib — full drug profile →

Conditions studied

• Cancer — all drugs for Cancer →

Sponsor

Johannes Gutenberg University Mainz

Who can join

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

Sponsor's own description

The purpose of the CaboAveNEC trial is to investigate the clinical activity and safety of Cabozantinib in combination with avelumab in patients refractory to standard chemotherapy with advanced neuroendocrine neoplasias G3 (NEN G3).

Publications & conference data

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

1. Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
   Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898
2. Gastroenteropancreatic neuroendocrine neoplasms: epidemiology, genetics, and treatment.
   Tan B, Zhang B, Chen H. · · 2024 · cited 10× · PMID 39411312 · DOI 10.3389/fendo.2024.1424839
3. Progress in immunotherapy for neuroendocrine neoplasm of the digestive system.
   Pan WX, Zhang XM, Hao SL, Han W. · · 2023 · cited 7× · PMID 37475845 · DOI 10.3748/wjg.v29.i26.4174
4. Treatment Approaches and Outcome of Patients with Neuroendocrine Neoplasia Grade 3 in German Real-World Clinical Practice.
   Luecke S, Fottner C, Lahner H, Jann H, et al · · 2022 · cited 5× · PMID 35681701 · DOI 10.3390/cancers14112718
5. Cabozantinib in neuroendocrine tumors: tackling drug activity and resistance mechanisms.
   Cella CA, Cazzoli R, Fazio N, De Petro G, et al · · 2023 · cited 4× · PMID 37855330 · DOI 10.1530/erc-23-0232
6. Potential Immunotherapy Targets for Liver-Directed Therapies, and the Current Scope of Immunotherapeutics for Liver-Related Malignancies.
   Charles J, Vrionis A, Mansur A, Mathias T, et al · · 2023 · cited 4× · PMID 37174089 · DOI 10.3390/cancers15092624
7. Cabozantinib for different endocrine tumours: killing two birds with one stone. A systematic review of the literature.
   Zago E, Galluzzo A, Pradella S, Antonuzzo L, et al · · 2024 · cited 2× · PMID 37851242 · DOI 10.1007/s12020-023-03526-0
8. Combining anti-PD-1 antibodies with surufatinib for gastrointestinal neuroendocrine carcinoma: Two cases report and review of literature.
   Gao LL, Gao DN, Yuan HT, Chen WQ, et al · · 2025 · PMID 40290678 · DOI 10.5306/wjco.v16.i4.102297