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

NCT04949191 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: INCB 54828-801
• Study Type: interventional
• Target: 10
• Locations: 4 countries
• Sites: 10

Brief Summary

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

Conditions

Advanced Malignancies

Keywords

pemigatinib

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

  An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and until 30 days after the last dose of study drug.

  up to at least 30 days after the last dose of study treatment or until toxicities resolve, return to baseline, or are deemed irreversible, whichever was longer (up to 1010 days)

Study Arms (3)

Study Treatment 1: Pemigatinib (INCB054828)

EXPERIMENTAL

Pemigatinib will be taken orally once daily

Drug: Pemigatinib

Study Treatment 2: Pemigatininb+ Retifanlimab

EXPERIMENTAL

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; Drug: Retifanlimab

Study Treatment 3: Pemigatininb + Pembrolizumab

EXPERIMENTAL

Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and pembroluzimab as per dosage instructions.

Drug: Pemigatinib; Drug: Pembrolizumab

Interventions

Pemigatinib DRUG

Pemigatinib tablets taken by mouth once daily as per protocol

Also known as: INCB054828

Study Treatment 1: Pemigatinib (INCB054828); Study Treatment 2: Pemigatininb+ Retifanlimab; Study Treatment 3: Pemigatininb + Pembrolizumab

Retifanlimab DRUG

Retifanlimab is administered over 60 minutes once every 4 weeks (Day 1 of a 28-day cycle)

Also known as: INCMGA0012

Study Treatment 2: Pemigatininb+ Retifanlimab

Pembrolizumab DRUG

Commercially labeled products

Study Treatment 3: Pemigatininb + Pembrolizumab

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Able to access pemigatinib commercially or outside of a clinical trial.
• Permanently discontinued from the parent protocol for any reason.
• Women who are pregnant or breastfeeding or participants expecting to conceive or father children within the projected duration of the study.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (10)

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Oncology Specialists of Charlotte

Charlotte, North Carolina, 28207, United States

Location

Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

Virginia Cancer Specialists, Pc

Fairfax, Virginia, 22031, United States

Location

The Finsen Centre National Hospital

Copenhagen, 02100, Denmark

Location

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, 20133, Italy

Location

Istituto Nazionale Tumori Regina Elena Irccs

Rome, 00144, Italy

Location

Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

Siena, 53100, Italy

Location

Kanagawa Cancer Center

Yokohama, 241-8515, Japan

Location

MeSH Terms

Interventions

pemigatinib; pembrolizumab

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Peter Langmuir

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 2, 2021
• Study Start: July 8, 2021
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); JP (1); IT (3); US (5)