The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies.

An Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Pemigatinib

Safety and tolerability of pemigatinib.in monotherapy or combination in patients that have participated in a previous parent study to treat advanced malignancies.

Study Overview

• Status: Terminated
• Conditions: Advanced Malignancies
• Intervention / Treatment: Drug: Pemigatinib; Drug: Retifanlimab; Drug: Pembrolizumab

Detailed Description

A Phase 2 Open-Label, Multicenter, Rollover Study to evaluate the long term safety and tolerability of Pemigatinib and to provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Pemigatinib

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 02100
    • The Finsen Centre National Hospital
• Italy
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Rome, Italy, 00144
    • Istituto Nazionale Tumori Regina Elena Irccs
  • Siena, Italy, 53100
    • Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
• Japan
  • Yokohama-Shi, Japan, 241-8515
    • Kanagawa Cancer Center
• United States
  • California
    • Santa Monica, California, United States, 90404
      • John Wayne Cancer Institute
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Oncology Specialists of Charlotte
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • South Texas Accelerated Research Therapeutics
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Currently enrolled and receiving treatment in an Incyte-sponsored clinical study (parent protocol) of pemigatinib as monotherapy or combination therapy.
• Currently benefiting from and tolerating treatment with pemigatinib, as determined by the investigator.
• Demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.
• Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures.
• Currently have no evidence of progressive disease, as determined by the investigator, following treatment with pemigatinib as monotherapy or combination therapy.
• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

• Able to access pemigatinib commercially or outside of a clinical trial.
• Permanently discontinued from the parent protocol for any reason.
• No longer meet the inclusion/exclusion criteria from the parent protocol if still receiving treatment.
• Women who are pregnant or breastfeeding or participants expecting to conceive or father children within the projected duration of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Treatment 1: Pemigatinib (INCB054828); Pemigatinib will be taken orally once daily	Drug: Pemigatinib; Pemigatinib tablets taken by mouth once daily as per protocol; Other Names: INCB054828
Experimental: Study Treatment 2: Pemigatininb+ Retifanlimab; Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and retifanlimab will be administered once every 4 weeks	Drug: Pemigatinib; Pemigatinib tablets taken by mouth once daily as per protocol; Other Names: INCB054828; Drug: Retifanlimab; Retifanlimab is administered over 60 minutes once every 4 weeks (Day 1 of a 28-day cycle); Other Names: INCMGA0012
Experimental: Study Treatment 3: Pemigatininb + Pembrolizumab; Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and pembroluzimab as per dosage instructions.	Drug: Pemigatinib; Pemigatinib tablets taken by mouth once daily as per protocol; Other Names: INCB054828; Drug: Pembrolizumab; Commercially labeled products

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatment Emergent Adverse Events (TEAEs)	Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.	up to 30 days after last dose

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Peter Langmuir, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Actual): April 11, 2024
• Study Completion (Actual): April 11, 2024

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Estimated): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: pemigatinib
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Pembrolizumab
• Other Study ID Numbers: INCB 54828-801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No