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Status:

RECRUITING

Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Malignant Female Reproductive System Neoplasm

Malignant Solid Neoplasm

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbocicli...

Detailed Description

PRIMARY OBJECTIVE: I. To investigate the efficacy of neratinib plus palbociclib (PD-0332991) compared to neratinib maleate (neratinib) alone in patients with HER2+ gynecologic cancers and HER2+ solid...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N5 based on the presence of an actionable mutation as defined in EAY191
  • Patients must have a HER2 amplified solid tumor except breast cancer. Patient's cancer must have HER2 amplification as defined with ≥ 7 copies by next generation sequencing (NGS) testing
  • Patients must have recurrent or persistent disease
  • No known evidence of RB1 loss or deletion including copy number loss or deleterious mutation
  • Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or, if disease cannot be safely biopsied, have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191)
  • Patients must have measurable disease based on RECIST 1.1. A second measurable lesion outside of the biopsiable lesion is required
  • Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression for 3 months or more and patient is not on steroids and is asymptomatic
  • No known leptomeningeal disease
  • Patients may have received up to 5 prior lines of systemic therapy
  • Prior therapy with trastuzumab or pertuzumab, either alone or in combination, antibody drug conjugates (ADC) such as DS8201a or T-DM1 is allowed
  • Prior therapy with tyrosine kinase inhibitors (TKI) such as neratinib or tucatinib is not allowed
  • No prior therapy with CDK4/6 inhibition
  • No cancer directed therapy within 3 weeks prior to registration. For oral therapy, the washout can be reduced to greater than or equal to 5 half lives of the drug. No HER2 targeting ADCs within 30 days prior to registration
  • Age ≥ 18
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
  • Not pregnant and not nursing
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
  • Platelets ≥ 100,000 cells/mm\^3
  • Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) ≥ 9 g/dl is acceptable)
  • Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula
  • Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional upper limit of normal (ULN)
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  • No active infection requiring parenteral antibiotics
  • No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
  • No current evidence of malabsorption or chronic diarrhea or any other significant gastro-intestinal disease (e.g gastrectomy, ileal bypass, Crohn's disease, gastroparesis), associated with moderate to severe diarrhea (grade 2 or more) or inability to tolerate oral therapy
  • No lung disease causing dyspnea at rest
  • No interstitial lung disease with ongoing signs and symptoms at the time of registration
  • No history of allergic reaction to the study agents, compound of similar chemical or biologic composition of the study agents or any of their excipients

Exclusion

    Key Trial Info

    Start Date :

    May 7 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    February 20 2027

    Estimated Enrollment :

    70 Patients enrolled

    Trial Details

    Trial ID

    NCT06126276

    Start Date

    May 7 2024

    End Date

    February 20 2027

    Last Update

    January 9 2026

    Active Locations (175)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 44 (175 locations)

    1

    University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, United States, 35233

    2

    University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, United States, 36688

    3

    Alaska Women's Cancer Care

    Anchorage, Alaska, United States, 99508

    4

    UC San Diego Health System - Encinitas

    Encinitas, California, United States, 92024