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

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

Detailed Description
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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

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

Conditions
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Advanced Malignancies

Intervention / Treatment
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* Drug: Pemigatinib
* Drug: Retifanlimab
* Drug: Pembrolizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pemigatinib