CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 474 enrolled
Drug / intervention
MSB0010718Cdrug
Likely dose
MSB0010718C 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02926196
NCT02926196Phase 3Completed

Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab: A Phase III Randomized Trial. Sponsor: Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche, Università di Padova

Istituto Oncologico Veneto IRCCS·interventional·Posted Oct 6, 2016·Updated Dec 12, 2025

In Brief

A Phase 3 clinical trial evaluating MSB0010718C for Triple Negative Breast Neoplasms. Completed, enrolled 474 participants across 70 sites in 2 countries.

Detailed Summary

Phase III randomized trial of the anti-PD-L1 antibody avelumab as adjuvant or post-neoadjuvant treatment for high-risk triple negative breast cancer patients. The overall protocol-defined patient population will include the following two strata of patients: * Stratum A - Patients who have completed treatment with curative intent including surgery of the primary tumor followed by adjuvant chemotherapy . * Stratum B - Patients who have completed treatment with curative intent including neoadjuvant chemotherapy followed by surgery of the primary tumor and (if indicated) further adjuvant chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly, United Kingdom

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 6, 2016
Enrollment StartJun 17, 2016
Primary CompletionJun 1, 2024
Study CompletionOct 9, 2025
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 9.7 years ago

Interventions

MSB0010718Cdrug

MSB0010718C-Avelumab is formulated as vials of 200 mg strength for IV administration