The Purpose of the Study is to Continue to Provide Pemiga... | NCT04949191

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pemigatinib	Drug	Pemigatinib tablets taken by mouth once daily as per protocol	Study Treatment 1: Pemigatinib (INCB054828) Study Treatment 2: Pemigatininb+ Retifanlimab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Eligibility Module

Name	Affiliation	Role
Peter Langmuir	Incyte Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
John Wayne Cancer Institute		Santa Monica	California	90404	United States
Oncology Specialists of Charlotte

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pemigatinib 6 mg Monotherapy	Participants originally enrolled in a parent study (54828-201 [NCT02872714], 54828-202 [NCT02924376], or 54828-207 [NCT03822117]), who received clinical benefit from pemigatinib, and who did not have access to pemigatinib outside of a clinical trial self-administered oral pemigatinib 6 milligrams (mg) once daily (QD), either continuously in 21-day cycles or on a 2-weeks-on therapy/1-week-off therapy schedule in 21-day cycles. Pemigatinib was administered at the same dose received in the parent studies until documented disease progression or unacceptable toxicity.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 17, 2021	Jun 10, 2024

Arm/Group Information

ID	Title	Description
BG000	Pemigatinib 6 mg and 13.5 mg Monotherapy	Participants originally enrolled in a parent study (54828-201 [NCT02872714], 54828-202 [NCT02924376], or 54828-207 [NCT03822117]), who received clinical benefit from pemigatinib, and who did not have access to pemigatinib outside of a clinical trial self-administered oral pemigatinib 6 milligrams (mg) or 13.5 mg once daily (QD), either continuously in 21-day cycles or on a 2-weeks-on therapy/1-week-off therapy schedule in 21-day cycles. Pemigatinib was administered at the same dose received in the parent studies until documented disease progression or unacceptable toxicity.
BG001	Pemigatinib 9 mg Monotherapy	Participants originally enrolled in a parent study (54828-201 [NCT02872714], 54828-202 [NCT02924376], or 54828-207 [NCT03822117]), who received clinical benefit from pemigatinib, and who did not have access to pemigatinib outside of a clinical trial self-administered oral pemigatinib 9 mg QD, either continuously in 21-day cycles or on a 2-weeks-on therapy/1-week-off therapy schedule in 21-day cycles. Pemigatinib was administered at the same dose received in the parent studies until documented disease progression or unacceptable toxicity.
BG002	Pemigatinib Combination	Participants originally enrolled in parent study 54828-101 (NCT02393248), who received clinical benefit from the combination of pemigatinib plus pembrolizumab, and who did not have access to the combination outside of a clinical trial received received the combination of pemigatinib and pembrolizumab. Participants received pembrolizumab intravenously at 200 mg once every 3 weeks on Day 1 of each 21-day cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0004 BG0015 BG0021 BG00310

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

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Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Safety Population: all participants who received at least 1 dose of study treatment in this study

Posted

Count of Participants

Participants

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)

ID	Title	Description
OG000	Pemigatinib 6 mg Monotherapy	Participants originally enrolled in a parent study (54828-201 [NCT02872714], 54828-202 [NCT02924376], or 54828-207 [NCT03822117]), who received clinical benefit from pemigatinib, and who did not have access to pemigatinib outside of a clinical trial self-administered oral pemigatinib 6 milligrams (mg) once daily (QD), either continuously in 21-day cycles or on a 2-weeks-on therapy/1-week-off therapy schedule in 21-day cycles. Pemigatinib was administered at the same dose received in the parent studies until documented disease progression or unacceptable toxicity.
OG001	Pemigatinib 9 mg Monotherapy	Participants originally enrolled in a parent study (54828-201 [NCT02872714], 54828-202 [NCT02924376], or 54828-207 [NCT03822117]), who received clinical benefit from pemigatinib, and who did not have access to pemigatinib outside of a clinical trial self-administered oral pemigatinib 9 mg QD, either continuously in 21-day cycles or on a 2-weeks-on therapy/1-week-off therapy schedule in 21-day cycles. Pemigatinib was administered at the same dose received in the parent studies until documented disease progression or unacceptable toxicity.
OG002	Pemigatinib 13.5 mg Monotherapy	Participants originally enrolled in a parent study (54828-201 [NCT02872714], 54828-202 [NCT02924376], or 54828-207 [NCT03822117]), who received clinical benefit from pemigatinib, and who did not have access to pemigatinib outside of a clinical trial self-administered oral pemigatinib 13.5 mg QD, either continuously in 21-day cycles or on a 2-weeks-on therapy/1-week-off therapy schedule in 21-day cycles. Pemigatinib was administered at the same dose received in the parent studies until documented disease progression or unacceptable toxicity.
OG003	Pemigatinib Combination	Participants originally enrolled in parent study 54828-101 (NCT02393248), who received clinical benefit from the combination of pemigatinib plus pembrolizumab, and who did not have access to the combination outside of a clinical trial received received the combination of pemigatinib and pembrolizumab. Participants received pembrolizumab intravenously at 200 mg once every 3 weeks on Day 1 of each 21-day cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.

Units	Counts
Participants	OG0002 OG0015 OG0022 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0015 OG0021 OG003

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pemigatinib 6 mg Monotherapy	Participants originally enrolled in a parent study (54828-201 [NCT02872714], 54828-202 [NCT02924376], or 54828-207 [NCT03822117]), who received clinical benefit from pemigatinib, and who did not have access to pemigatinib outside of a clinical trial self-administered oral pemigatinib 6 milligrams (mg) once daily (QD), either continuously in 21-day cycles or on a 2-weeks-on therapy/1-week-off therapy schedule in 21-day cycles. Pemigatinib was administered at the same dose received in the parent studies until documented disease progression or unacceptable toxicity.	2	1	2	1	2
EG001	Pemigatinib 9 mg Monotherapy	Participants originally enrolled in a parent study (54828-201 [NCT02872714], 54828-202 [NCT02924376], or 54828-207 [NCT03822117]), who received clinical benefit from pemigatinib, and who did not have access to pemigatinib outside of a clinical trial self-administered oral pemigatinib 9 mg QD, either continuously in 21-day cycles or on a 2-weeks-on therapy/1-week-off therapy schedule in 21-day cycles. Pemigatinib was administered at the same dose received in the parent studies until documented disease progression or unacceptable toxicity.	5	2	5	5	5
EG002	Pemigatinib 13.5 mg Monotherapy	Participants originally enrolled in a parent study (54828-201 [NCT02872714], 54828-202 [NCT02924376], or 54828-207 [NCT03822117]), who received clinical benefit from pemigatinib, and who did not have access to pemigatinib outside of a clinical trial self-administered oral pemigatinib 13.5 mg QD, either continuously in 21-day cycles or on a 2-weeks-on therapy/1-week-off therapy schedule in 21-day cycles. Pemigatinib was administered at the same dose received in the parent studies until documented disease progression or unacceptable toxicity.	2	0	2	1	2
EG003	Pemigatinib Combination	Participants originally enrolled in parent study 54828-101 (NCT02393248), who received clinical benefit from the combination of pemigatinib plus pembrolizumab, and who did not have access to the combination outside of a clinical trial received received the combination of pemigatinib and pembrolizumab. Participants received pembrolizumab intravenously at 200 mg once every 3 weeks on Day 1 of each 21-day cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.	1	0	1	1	1

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG0030 affected1 at risk
Asthenia	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Blood creatinine increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 affected2 at risk EG0010 affected5 at risk EG0020 affected2 at risk EG003
Blood magnesium decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Cataract	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Corneal erosion	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected5 at risk EG0021 affected2 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected5 at risk EG0020 affected2 at risk EG003
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected5 at risk EG0020 affected2 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected5 at risk EG0020 affected2 at risk EG003
Multiple allergies	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected5 at risk EG0021 affected2 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected5 at risk EG0021 affected2 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Nail infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Onychalgia	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Onychomadesis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Onychomycosis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0021 affected2 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected2 at risk EG0014 affected5 at risk EG0020 affected2 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected2 at risk EG0010 affected5 at risk EG0020 affected2 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Porokeratosis	Congenital, familial and genetic disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected5 at risk EG0021 affected2 at risk EG003
Rectal fissure	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Shoulder fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected2 at risk EG0014 affected5 at risk EG0020 affected2 at risk EG003
Ulcerative keratitis	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected2 at risk EG0010 affected5 at risk EG0020 affected2 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected5 at risk EG0021 affected2 at risk EG003
Vitreous floaters	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected5 at risk EG0021 affected2 at risk EG003
Wound infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected5 at risk EG0020 affected2 at risk EG003

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute kidney injury	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG0030 affected1 at risk
Cardiac failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected2 at risk EG0010 affected5 at risk EG0020 affected2 at risk EG003
Seizure	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected5 at risk EG0020 affected2 at risk EG003