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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05888844




Registration number
NCT05888844
Ethics application status
Date submitted
24/05/2023
Date registered
5/06/2023

Titles & IDs
Public title
A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma
Scientific title
A Phase 2 Study Evaluating INCB099280 in Participants With Advanced Squamous Cell Carcinoma
Secondary ID [1] 0 0
2022-502476-23-00
Secondary ID [2] 0 0
INCB 99280-212
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - INCB099280

Experimental: Part 1: INCB099280 Dose 1 - Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.

Experimental: Part 1: INCB099280 Dose 2 - Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.

Experimental: Part 1: INCB099280 Dose 3 - Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years.

Experimental: Part 2: INCB099280 Dose selected from Part 1 - Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years.


Treatment: Drugs: INCB099280
Administered as specified in the treatment arm description.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
Up to 2 years
Primary outcome [2] 0 0
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Up to 2 years 3 months
Primary outcome [3] 0 0
Number of participants with TEAEs leading to dose modification or discontinuation
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Disease Control Rate (DCR)
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
Duration Of Response (DOR)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Time to Response (TTR)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Progression-free survival (PFS)
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Up to 2 years
Secondary outcome [6] 0 0
INCB099280 pharmacokinetic (PK) in Plasma
Timepoint [6] 0 0
Pre dose and 1, 2 and 6 hours post dose on Cycle 1 Day 1 and Cycle 2 Day 1. Pre dose every other cycle until Cycle 11 Day 1 (Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1 and Cycle 11 Day 1) (each cycle is 28 days)

Eligibility
Key inclusion criteria
* Histopathological diagnosis of cSCC.
* Previously untreated or recurrent locally advanced (without nodal metastases) or metastatic (distant or regional metastasis) cSCC not amenable to curative surgery and/or radiotherapy.
* Measurable disease based on either radiographic imaging per RECIST 1.1 or WHO criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Life expectancy > 3 months.
* Willingness to avoid pregnancy or fathering children.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known history of an additional malignancy.
* Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.
* Toxicity from prior therapy that has not recovered.
* Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent; treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL-2, 4-1BB, CAR-T cell).
* Received thoracic radiation within 6 months of the first dose of study treatment.
* Participation in another interventional clinical study while receiving INCB099280.
* Impaired cardiac function or clinically significant cardiac disease.
* History or evidence of interstitial lung disease including noninfectious pneumonitis.
* Presence of gastrointestinal conditions that may affect drug absorption.
* Any autoimmune disease requiring systemic treatment in the past 5 years.
* Diagnosis of primary immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent.
* Active infection requiring systemic therapy.
* History of organ transplantation, including allogeneic stem cell transplantation.
* Receipt of systemic antibiotics within 28 days of first dose of study treatment.
* Probiotic usage is prohibited during screening and throughout the study treatment period.
* Received a live vaccine within 28 days of the planned start of study drug.
* Laboratory values outside the Protocol-defined ranges.
* Inadequate organ function.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Border Medical Oncology Research Unit - Albury
Recruitment hospital [2] 0 0
Townsville Cancer Centre - Townsville
Recruitment hospital [3] 0 0
Princess Alexandra Hospital Australia - Woolloongabba
Recruitment hospital [4] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 0 0
Monash Medical Centre Clayton - Clayton
Recruitment postcode(s) [1] 0 0
02640 - Albury
Recruitment postcode(s) [2] 0 0
04814 - Townsville
Recruitment postcode(s) [3] 0 0
04102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
03128 - Box Hill
Recruitment postcode(s) [5] 0 0
03168 - Clayton
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Barretos
Country [2] 0 0
Brazil
State/province [2] 0 0
Florianópolis
Country [3] 0 0
Brazil
State/province [3] 0 0
Ijui
Country [4] 0 0
Brazil
State/province [4] 0 0
JAÚ
Country [5] 0 0
Brazil
State/province [5] 0 0
Passo Fundo
Country [6] 0 0
Brazil
State/province [6] 0 0
Porto Alegre
Country [7] 0 0
Brazil
State/province [7] 0 0
Santa Cruz Do Sul
Country [8] 0 0
Brazil
State/province [8] 0 0
Santo André
Country [9] 0 0
Brazil
State/province [9] 0 0
São Paulo
Country [10] 0 0
Canada
State/province [10] 0 0
Nova Scotia
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Chile
State/province [12] 0 0
Santiago
Country [13] 0 0
Chile
State/province [13] 0 0
Temuco
Country [14] 0 0
Chile
State/province [14] 0 0
Valdivia
Country [15] 0 0
Croatia
State/province [15] 0 0
Rijeka
Country [16] 0 0
Croatia
State/province [16] 0 0
Zagreb
Country [17] 0 0
France
State/province [17] 0 0
Bobigny Cedex
Country [18] 0 0
France
State/province [18] 0 0
Bordeaux
Country [19] 0 0
France
State/province [19] 0 0
Boulogne-billancourt
Country [20] 0 0
France
State/province [20] 0 0
Clermont Ferrand Cedex 1
Country [21] 0 0
France
State/province [21] 0 0
Dijon Cedex
Country [22] 0 0
France
State/province [22] 0 0
Dijon
Country [23] 0 0
France
State/province [23] 0 0
La Tronche
Country [24] 0 0
France
State/province [24] 0 0
Lille Cedex
Country [25] 0 0
France
State/province [25] 0 0
Marseille Cedex 5
Country [26] 0 0
France
State/province [26] 0 0
Nantes
Country [27] 0 0
France
State/province [27] 0 0
Nice Cedex 3
Country [28] 0 0
France
State/province [28] 0 0
Paris
Country [29] 0 0
France
State/province [29] 0 0
Pau Cedex
Country [30] 0 0
France
State/province [30] 0 0
Pierre Bénite Cedex
Country [31] 0 0
France
State/province [31] 0 0
Rouen Cedex
Country [32] 0 0
France
State/province [32] 0 0
Saint Etienne Cedex 2
Country [33] 0 0
France
State/province [33] 0 0
Villejuif Cedex
Country [34] 0 0
Hungary
State/province [34] 0 0
Budapest
Country [35] 0 0
Hungary
State/province [35] 0 0
Pecs
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Seongnam-si,
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Seoul
Country [38] 0 0
Montenegro
State/province [38] 0 0
Podgorica
Country [39] 0 0
New Zealand
State/province [39] 0 0
Hamilton
Country [40] 0 0
North Macedonia
State/province [40] 0 0
Skopje
Country [41] 0 0
Romania
State/province [41] 0 0
Bucuresti
Country [42] 0 0
Romania
State/province [42] 0 0
Cluj Napoca
Country [43] 0 0
Romania
State/province [43] 0 0
Cluj-napoca
Country [44] 0 0
Romania
State/province [44] 0 0
Craiova
Country [45] 0 0
Romania
State/province [45] 0 0
Suceava
Country [46] 0 0
Romania
State/province [46] 0 0
Timisoara
Country [47] 0 0
South Africa
State/province [47] 0 0
Centurion
Country [48] 0 0
South Africa
State/province [48] 0 0
Johannesburg
Country [49] 0 0
South Africa
State/province [49] 0 0
Port Elizabeth
Country [50] 0 0
South Africa
State/province [50] 0 0
Pretoria
Country [51] 0 0
Spain
State/province [51] 0 0
Badalona
Country [52] 0 0
Spain
State/province [52] 0 0
Barcelona
Country [53] 0 0
Spain
State/province [53] 0 0
El Palmar
Country [54] 0 0
Spain
State/province [54] 0 0
L'hospitalet de Llobregat
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
Spain
State/province [56] 0 0
Málaga
Country [57] 0 0
Spain
State/province [57] 0 0
Pamplona
Country [58] 0 0
Spain
State/province [58] 0 0
Sevilla
Country [59] 0 0
Spain
State/province [59] 0 0
Zaragoza
Country [60] 0 0
Turkey
State/province [60] 0 0
Adana
Country [61] 0 0
Turkey
State/province [61] 0 0
Ankara
Country [62] 0 0
Turkey
State/province [62] 0 0
Edirne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyte Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Incyte Medical Monitor
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Incyte Corporation Call Center (US)
Address 0 0
Country 0 0
Phone 0 0
1.855.463.3463
Fax 0 0
Email 0 0
medinfo@incyte.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Available to whom?
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.incyte.com/our-company/compliance-and-transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05888844