EAY191-N5

A Randomized Trial of Neratinib, A Pan-ERBB Inhibitor, Alone or in Combination with Palbociclib, a CDK4/6 Inhibitor, in Patients with HER2+ Gynecologic Cancers and Other Solid Tumors: A ComboMATCH Treatment Trial

Principal Investigator

Haider Mahdi, MD

Status

Disease Site

Gynecologic [GY] Multiple

Phase

II

Developmental Therapeutics

No

Primary Objective

To investigate the efficacy of neratinib plus palbociclib (PD-0332991) compared to
neratinib alone in patients with HER2+ gynecologic cancers an HER2+ solid
tumors by evaluating progression-free survival (PFS)

 

Patient Population

HER2 amplified solid tumors except breast cancer as determined by the ComboMATCH screening assessment. Patients must have recurrent or persistent disease. Measurable and biopsiable disease as defined by RECIST 1.1. A second measurable lesion outside of the biopsiable lesion is required. Patients may have received up to 5 prior lines of systemic therapy. One prior line of anti-HER2 therapy is allowed except tyrosine kinase inhibitors (TKI) or antibody drug conjugates (ADC). No prior therapy with CDK4/6 inhibition.No cancer directed therapy within 3 weeks prior to registration.

Target Accrual

70