CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 100 enrolled
Drug / intervention
Vinorelbine +3 moredrug
Likely dose
Not stated in 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/NCT03414658
NCT03414658Phase 2Active
CompareCT.gov

A Randomized, Phase II Study Comparing Trastuzumab and Vinorelbine in Combination With Avelumab or Avelumab and Utomilumab (41BB/CD137 Agonist), in Patients With HER2-positive Metastatic Breast Cancer Who Have Progressed on Prior Trastuzumab and Pertuzumab

Adrienne G. Waks·interventional·Posted Jan 30, 2018·Updated Jul 2, 2025

In Brief

A Phase 2 clinical trial evaluating Vinorelbine, Trastuzumab, and 2 other interventions for Breast Cancer. Active but no longer recruiting, targeting 100 participants across 17 sites.

Detailed Summary

This research study is studying a combination of drugs as a possible treatment for breast cancer. The drugs involved in this study are: * Group A: Trastuzumab (Herceptin) + Vinorelbine (Navelbine) * Group B: Trastuzumab + Vinorelbine + Avelumab * Group C: Trastuzumab + Vinorelbine + Avelumab + Utomilumab (PF-05082566)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsPfizer, Breast Cancer Research Foundation, Johns Hopkins University

Timeline

Phase 2ActiveOverdue
201820192020202120222023202420252026
First PostedJan 30, 2018
Enrollment StartJun 21, 2018
Primary CompletionMay 1, 2023
Study CompletionMay 31, 2026
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 8.4 years ago

Interventions

Vinorelbinedrug

work by interfering with cell division, which leaves the tumor unable to grow and spread

Trastuzumabdrug

trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.

Avelumabdrug

monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein

Utomilumabdrug

Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells