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

Sponsor
Johannes Gutenberg University Mainz
Study ID
NCT05289856
Phase
PHASE2
Status
Unknown

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • combination of Avelumab and Cabozantinib — DRUG
    Cabozantinib 40 mg daily PO in combination with Avelumab at a dose of 800 mg as a 1h intravenous (i.v.) infusion every two weeks (q2w) until disease progression (PD), unacceptable toxicity, or any criterion for treatment withdrawalis met, for a maximum of 12 months

Study Details

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).

Key Dates

Start date
Mar 28, 2022
Status verified
Mar 2024
Primary completion
Mar 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: combination of Avelumab and Cabozantinib
    800 mg Avelumab every 2 weeks and 40 mg Cabozantinib daily

Primary Outcome Measure

Disease control rate (DCR: CR, PR, SD) [ Time Frame: 16 weeks ]

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