Advanced MalignanciesPhase 2NCT04949191
The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies.
A Phase 2 study testing Pemigatinib, Retifanlimab and Pembrolizumab in people with Advanced Malignancies, run by Incyte Corporation at 10 sites in 4 countries.
Trial summary
Safety and tolerability of pemigatinib.in monotherapy or combination in patients that have participated in a previous parent study to treat advanced malignancies. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Advanced Malignancies
- What is being tested?
- Pemigatinib, Retifanlimab and Pembrolizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 8 Jul 2021to 11 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United States5 sites
Oncology Specialists of Charlotte
Charlotte, North Carolina, 28207
Virginia Cancer Specialists, Pc
Fairfax, Virginia, 22031
Md Anderson Cancer Center
Houston, Texas, 77030
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
John Wayne Cancer Institute
Santa Monica, California, 90404
Italy3 sites
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, 20133
Istituto Nazionale Tumori Regina Elena Irccs
Rome, 00144
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
Siena, 53100
About this study
Official title: An Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Pemigatinib
Safety and tolerability of pemigatinib.in monotherapy or combination in patients that have participated in a previous parent study to treat advanced malignancies.
Read the detailed 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
- Conditions
- Advanced Malignancies
- Being tested
- Pemigatinib, Retifanlimab, Pembrolizumab
- Keywords
- pemigatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemigatinibDrug
Also called INCB054828
Pemigatinib tablets taken by mouth once daily as per protocol
RetifanlimabDrug
Also called INCMGA0012
Retifanlimab is administered over 60 minutes once every 4 weeks (Day 1 of a 28-day cycle)
PembrolizumabDrug
Commercially labeled products
| Study group | Role | What they receive |
|---|---|---|
| Study Treatment 1: Pemigatinib (INCB054828) | Experimental | Pemigatinib will be taken orally once daily Receives: 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 Receives: 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. Receives: Drug: Pemigatinib; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start8 Jul 2021
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
Why it stopped: A business decision due to availability of commercial drug and other options for accessing study drug treatment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced MalignanciesStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Langmuir, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949191
- Sponsor's protocol ID
- INCB 54828-801
- Status last verified
- Aug 2024
- First submitted
- 25 Jun 2021
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Pemigatinib
- ClinicalTrials.gov ID
- NCT04949191
- Acronym / sponsor ID
- INCB 54828-801
- Conditions
- Advanced Malignancies
- Keywords
- pemigatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A business decision due to availability of commercial drug and other options for accessing study drug treatment.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Treatment 1: Pemigatinib (INCB054828) | Experimental | Drug: PemigatinibPemigatinib will be taken orally once daily |
| Study Treatment 2: Pemigatininb+ Retifanlimab | Experimental | Drug: Pemigatinib, Drug: RetifanlimabParticipants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and retifanlimab will be administered once every 4 weeks |
| Study Treatment 3: Pemigatininb + Pembrolizumab | Experimental | Drug: Pemigatinib, Drug: PembrolizumabParticipants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and pembroluzimab as per dosage instructions. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemigatinibAlso: INCB054828Pemigatinib tablets taken by mouth once daily as per protocol | Drug | Study Treatment 1: Pemigatinib (INCB054828), Study Treatment 2: Pemigatininb+ Retifanlimab, Study Treatment 3: Pemigatininb + Pembrolizumab |
| RetifanlimabAlso: INCMGA0012Retifanlimab is administered over 60 minutes once every 4 weeks (Day 1 of a 28-day cycle) | Drug | Study Treatment 2: Pemigatininb+ Retifanlimab |
| PembrolizumabCommercially labeled products | Drug | Study Treatment 3: Pemigatininb + Pembrolizumab |
Primary outcome
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)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Langmuir study director
Incyte Corporation
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemigatinib, Retifanlimab and Pembrolizumab in people with Advanced Malignancies, run by Incyte Corporation at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Italy, Denmark, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.