Combined MEK, STAT3 and PD-1 Inhibition in Metastatic Pancreatic Ductal Adenocarcinoma

Part of paid clinical trials in Miami, Florida.

Sponsor
Peter Hosein, MD
Study ID
NCT05440942
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Trametinib — DRUG
    Trametinib will be administered orally once daily via tablet.
  • Ruxolitinib — DRUG
    Ruxolitinib will be administered orally twice daily (BID) via tablet.
  • Retifanlimab — DRUG
    Retifanlimab will be administered intravenously (IV) on Day 8 of a 28-day cycle..

Study Details

The purpose of this research is to test whether a combination treatment of Trametinib, Retifanlimab, and Ruxolitinib (TR\^2) will reduce tumor size in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).

Key Dates

Start date
Jan 19, 2023
Status verified
Feb 2025
Primary completion
May 30, 2025
Completion
May 30, 2025

Study Design

Enrollment
28 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Schedule A: TR^2 Dose Escalation/De-Escalation
    Participants in this group will receive Trametinib, Ruxolitinib and Retifanlimab in a dose escalation/de-escalation design to determine the maximum tolerated dose (MTD). Participants will receive Trametinib and Ruxolitinib for two weeks on (Days 1-14) and two weeks off (Days 15-28) and Retifanlimab on Day 8 of a 28-day cycle. Doses will be administered as follows: * Dose Level -1A: Trametinib 1 mg orally (PO), Ruxolitinib 5 mg PO, Retifanlimab 500 mg intravenously (IV); * Starting Dose Level 1A: Trametinib 1.5 mg PO, Ruxolitinib 10 mg PO, Retifanlimab 500 mg IV; * Dose Level 2A: Trametinib 2 mg PO, Ruxolitinib 10 mg PO, Retifanlimab 500 mg IV; * Dose Level 3A: Trametinib 2 mg PO, Ruxolitinib 15 mg PO, Retifanlimab 500 mg IV.
  • Experimental: Part 1 Schedule B: TR^2 Alternate Schedule
    Participants in this group will receive the MTD determined in Part 1 Schedule A on a continuous dosing cycle: Trametinib and Ruxolitinib on Days 1-28 and Retifanlimab on Day 8 of a 28-Day Cycle.
  • Experimental: Part 2: TR^2 Expansion Cohort
    Participants in this group will receive Trametinib, Ruxolitinib and Retifanlimab at the most appropriate dose and schedule determined in Part 1. Participants will continue to receive treatment as long as receiving clinical benefit or until disease progression.

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136-

Find similar trials in Miami, FL

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University of Miami· Miami, FL

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