CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Avelumab +1 moredrug
Likely dose
Avelumab IV plus axitinib PO (specific doses not stated in interventions)AI-extracted
Key inclusion· 6
  • ECOG performance status 0 or 1
  • Histologically confirmed recurrent or metastatic adenoid cystic carcinoma not amenable to curative surgery or radiotherapy
  • Measurable disease per RECIST 1.1
  • Evidence of disease progression within 6 months of enrollment or worsening disease-related symptoms
Key exclusion· 9
  • Prior treatment with immune checkpoint inhibitors (anti-PD-1/PD-L1)
  • Prior treatment with VEGF or VEGFR inhibitors
  • Active autoimmune disease that might deteriorate with immunotherapy (except type I diabetes, vitiligo, psoriasis, thyroid disease not requiring immunosuppression)
  • Prior organ transplantation including allogeneic stem-cell transplantation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03990571
NCT03990571Phase 2Completed

A Phase 2 Clinical Trial of Axitinib and Avelumab in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma (ACC)

M.D. Anderson Cancer Center·interventional·Posted Jun 19, 2019·Updated Oct 18, 2024

In Brief

A Phase 2 clinical trial evaluating Avelumab and Axitinib for Metastatic Adenoid Cystic Carcinoma and 2 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This phase II trial studies how well axitinib and avelumab work in treating patients with adenoid cystic carcinoma that has come back or spread to other places in the body. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving axitinib and avelumab together may help to control adenoid cystic carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 19, 2019
Enrollment StartJul 22, 2019
Primary CompletionMar 20, 2023
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 7.0 years ago

Interventions

Avelumabdrug

Given IV

Axitinibdrug

Given PO