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PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer

NCT04360941 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-04-06

No results posted yet for this study

Summary

This clinical study is aiming to determine the safest doses and schedule for the combination of two drugs named palbociclib and avelumab.

The study will also be investigating how effective the combination is for a subgroup of breast cancer patients whose cancer expresses the androgen receptor (AR) but not the oestrogen (hormone) or HER2 receptors. Palbociclib is a drug used in routine care for hormone-receptor (HR) positive and HER2 negative advanced breast cancer, the most common subtype of breast cancer.

It is possible that the combination of palbociclib and avelumab will be a more effective cancer treatment than each drug separately, but this is unknown and this study is needed to establish the best dosage and schedule of each drug as well as how effective the combination is.

Conditions

Interventions

DRUG

Palbociclib

Highly selective oral inhibitor of CDK4 and CDK6.

DRUG

Avelumab

Fully human IgG1 monoclonal antibody (mAb) binds to the PD-L1 cell surface ligand and blocks its interaction with the PD-1 cell surface receptor.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Breast Cancer Now

    collaborator OTHER

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Alicia Okines · The Royal Marsden Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-11
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04360941 on ClinicalTrials.gov