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

Incyte

Status and phase: Terminated; Phase 2

Conditions: Advanced Malignancies

Treatments: Drug: Retifanlimab; Drug: Pemigatinib; Drug: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04949191

INCB 54828-801

Details and patient eligibility

About

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

Full 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

Enrollment: 10 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Study Treatment 1: Pemigatinib (INCB054828)

Experimental group

Description:

Pemigatinib will be taken orally once daily

Treatment:

Drug: Pemigatinib

Study Treatment 2: Pemigatininb+ Retifanlimab

Experimental group

Description:

Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and retifanlimab will be administered once every 4 weeks

Treatment:

Drug: Pemigatinib

Drug: Retifanlimab

Study Treatment 3: Pemigatininb + Pembrolizumab

Experimental group

Description:

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

Treatment:

Drug: Pembrolizumab

Drug: Pemigatinib