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

Part of paid clinical trials in Santa Monica, California.

Sponsor
Incyte Corporation
Study ID
NCT04949191
Phase
PHASE2
Status
Terminated

Conditions

  • Advanced Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Pemigatinib — DRUG
    Pemigatinib tablets taken by mouth once daily as per protocol
  • Retifanlimab — DRUG
    Retifanlimab is administered over 60 minutes once every 4 weeks (Day 1 of a 28-day cycle)
  • Pembrolizumab — DRUG
    Commercially labeled products

Study Details

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

Key Dates

Start date
Jul 8, 2021
Status verified
Aug 2024
Primary completion
Apr 11, 2024
Completion
Apr 11, 2024

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study Treatment 1: Pemigatinib (INCB054828)
    Pemigatinib will be taken orally once daily
  • 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
  • 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.

Primary Outcome Measure

Number of Participants With Any Treatment-emergent Adverse Event (TEAE) [ Time Frame: 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) ]

Locations (5)

FacilityCityStateZIPSite coordinators
John Wayne Cancer InstituteSanta MonicaCalifornia90404-
Oncology Specialists of CharlotteCharlotteNorth Carolina28207-
Md Anderson Cancer CenterHoustonTexas77030-
South Texas Accelerated Research TherapeuticsSan AntonioTexas78229-
Virginia Cancer Specialists, PcFairfaxVirginia22031-

Find similar trials in Santa Monica, CA

By research site
John Wayne Cancer Institute· Santa Monica, CAOncology Specialists of Charlotte· Charlotte, NCMd Anderson Cancer Center· Houston, TXSouth Texas Accelerated Research Therapeutics· San Antonio, TXVirginia Cancer Specialists, Pc· Fairfax, VA

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