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CDK4/6 Inhibitor

Palbociclib + Pembrolizumab for Sarcoma

Phase 1

Recruiting

Led By Mohammed Milhem, MBBS

Research Sponsored by Mohammed Milhem

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any patient with the diagnosis of locally advanced, unresectable or undifferentiated pleomorphic sarcoma (UPS) who have progressed on at least 1 prior line of therapy and for whom pembrolizumab is an appropriate next standard treatment

ECOG Performance Status of less than or equal to 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to two years following completion of treatment

Awards & highlights

Study Summary

This trial tests a drug to see if it helps cancer treatment before it begins.

Who is the study for?

This trial is for males and females aged 12 or older with advanced, unresectable pleomorphic sarcoma who have tried at least one therapy. They must understand the study and agree to participate, have a decent performance status (ECOG ≤2), no active brain metastases, and not be pregnant or breastfeeding. Participants need proper organ function and can't join if they've had certain heart issues recently or used specific drugs within 4 weeks.Check my eligibility

What is being tested?

The trial tests Palbociclib in combination with Pembrolizumab on patients with undifferentiated pleomorphic sarcoma. It's an open-label study where all participants receive the same treatment without a comparison group, focusing on the effects of pre-treatment before standard care.See study design

What are the potential side effects?

Potential side effects include fatigue, nausea, blood cell count changes leading to increased infection risk or bleeding problems, liver issues indicated by altered lab values, kidney function changes, low calcium levels in blood, pneumonitis (lung inflammation), and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have advanced sarcoma, it's gotten worse after treatment, and pembrolizumab is my next treatment option.

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I can take care of myself but might not be able to do heavy physical work.

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I have had treatments before for my advanced or spreading cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to two years following completion of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to two years following completion of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two years following completion of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose limiting toxicities (DLTs) and adverse events (AEs) per CTCAE v5

Secondary outcome measures

Response rate per RECIST 1.1 criteria

Other outcome measures

Progression free survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Combination of Palbociclib with PembrolizumabExperimental Treatment2 Interventions

Palbociclib given for 2 weeks following a pre-treatment ultrasound guided biopsy used to establish an immunological baseline of the tumor microenvironment. After the conclusion of palbociclib therapy, a post-treatment biopsy will be performed to assess the impact of palbociclib on the tumor microenvironment; pembrolizumab will be started the same day as the second biopsy. After 2 doses of pembrolizumab, a third (optional) biopsy could be performed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Palbociclib

2017

Completed Phase 3

~3760

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mohammed MilhemLead Sponsor

6 Previous Clinical Trials

136 Total Patients Enrolled

Mohammed Milhem, MBBSPrincipal InvestigatorUniversity of Iowa Hospitals & Clinics

4 Previous Clinical Trials

92 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the parameters of this experiment open to additional participants?

"Evidenced by clinicaltrials.gov, this trial has concluded its recruitment period and is no longer enrolling participants. It was first posted on January 1st 2024 but the most recent update was made in November of 2023. However, 457 other studies are still searching for suitable patients to enrol in their respective trials."

Answered by AI

How has the pairing of palbociclib with pembrolizumab been demonstrated to be for patients?

"As this is an early Phase 1 clinical trial, the safety of combining palbociclib and pembrolizumab has been rated as a conservative 1. As yet, there are only sparse data demonstrating both efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Palbociclib and Pembrolizumab in Undifferentiated Pleomorphic Sarcoma (UPS)

Mohammed Milhem 2024. "Palbociclib and Pembrolizumab in Undifferentiated Pleomorphic Sarcoma (UPS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06113809.