Palbociclib and Pembrolizumab in Sarcoma

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
John Rieth
Study ID
NCT06113809
Phase
PHASE1
Status
Recruiting
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Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Palbociclib — DRUG
    Palbociclib is a CDK4/6 inhibitor. Palbociclib, 125 mg, (pediatric dose 75mg/m2 up to 125mg) daily for 21 days out of every 28 days, PO (orally) starting 14 days prior to Pembrolizumab
  • Pembrolizumab — DRUG
    Pembrolizumab is a PD-1 blocking antibody. Given 14 days following Palbociclib: Pembrolizumab, 200 mg, once every three weeks, intravenously (IV)

Study Details

This is a single-arm open-label window of opportunity clinical study assessing the impact of pre-treatment with palbociclib in patients with soft tissue sarcomas for which PD-1 inhibitors are approved (includes undifferentiated pleomorphic sarcoma, myxofibrosarcoma, angiosarcoma, pleomorphic rhabdomyosarcoma, pleomorphic liposarcoma, or alveolar soft part sarcoma).

Key Dates

Start date
Feb 1, 2024
Status verified
May 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination of Palbociclib with Pembrolizumab
    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.

Primary Outcome Measure

Dose limiting toxicities (DLTs) and adverse events (AEs) per CTCAE v5 [ Time Frame: The dose limiting toxicity period is 4 weeks after starting the first dose of pembrolizumab ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Hospitals & ClinicsIowa CityIowa52242
John Rieth, MD
[email protected]
(319) 356-1616

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By research site
University of Iowa Hospitals & Clinics· Iowa City, IA

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