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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05879822




Registration number
NCT05879822
Ethics application status
Date submitted
19/05/2023
Date registered
30/05/2023

Titles & IDs
Public title
A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive
Scientific title
A Phase 2 Study Evaluating INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive
Secondary ID [1] 0 0
2022-502716-37-00
Secondary ID [2] 0 0
INCB 99280-211
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Condition category
Condition code

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
INCB099280 pharmacokinetic (PK) in Plasma
Timepoint [3] 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
* Immunotherapy naive and without access to approved and/or available immune checkpoint inhibitor (ICI) therapy.
* Measurable disease per RECIST v1.1.
* One of the following disease settings:

* Unresectable or metastatic Child-Pugh Class A hepatocellular carcinoma (HCC) not eligible for surgical and/or locoregional therapy and have not received prior systemic therapy or had disease progression following primary therapy.
* Unresectable or metastatic cutaneous melanoma and have not received more than 1 previous systemic therapy for advanced disease.
* Unresectable Stage III PD-L1-positive (TPS = 50% using the Dako PD-L1 IHC 22C3 assay) non-small cell lung cancer (NSCLC) without actionable molecular biomarkers and have not received prior systemic therapy and where chemoradiation is contraindicated; in addition, able to provide fresh or archival tumor tissue for central confirmation of PD-L1 expression.
* Stage IV PD-L1-positive (TPS = 50% using the Dako PD-L1 IHC 22C3 assay) NSCLC without actionable molecular biomarkers and have not received prior systemic therapy; in addition, able to provide fresh or archival tumor tissue for central confirmation of PD-L1 expression.
* Relapsed or Stage IV clear cell renal cell carcinoma (RCC) after having received 1 prior systemic therapy for relapsed or Stage IV disease.
* Cisplatin-ineligible, locally advanced or Stage IV urothelial cancer (UC) and have not received prior systemic therapy for locally advanced or Stage IV UC and able to provide fresh or archival tumor tissue for central confirmation of PD-L1 expression using the Dako PD-L1 IHC 22C3 assay.
* Advanced or metastatic microsatellite instability high (MSI-H) or deficient mismatch repair (dMMR) (as determined by an approved assay) solid tumors and able to provide fresh or archival tumor tissue for central confirmation of MSI-H or dMMR.
* 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 PD-1, anti-PD-L1, or anti-PD-L2 agent or 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 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.

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
30/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/01/2027
Actual
Sample size
Target
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Barretos
Country [2] 0 0
Brazil
State/province [2] 0 0
Curitiba
Country [3] 0 0
Brazil
State/province [3] 0 0
Ijui
Country [4] 0 0
Brazil
State/province [4] 0 0
Itajaí
Country [5] 0 0
Brazil
State/province [5] 0 0
JAÚ
Country [6] 0 0
Brazil
State/province [6] 0 0
Londrina
Country [7] 0 0
Brazil
State/province [7] 0 0
Porto Alegre
Country [8] 0 0
Brazil
State/province [8] 0 0
Santo Andre
Country [9] 0 0
Brazil
State/province [9] 0 0
São Paulo
Country [10] 0 0
China
State/province [10] 0 0
Nanning
Country [11] 0 0
Georgia
State/province [11] 0 0
Batumi
Country [12] 0 0
Georgia
State/province [12] 0 0
Kutaisi
Country [13] 0 0
Georgia
State/province [13] 0 0
Tbilisi
Country [14] 0 0
Greece
State/province [14] 0 0
Athens
Country [15] 0 0
Greece
State/province [15] 0 0
Thessaloniki
Country [16] 0 0
Hungary
State/province [16] 0 0
Budapest
Country [17] 0 0
New Zealand
State/province [17] 0 0
Dunedin
Country [18] 0 0
New Zealand
State/province [18] 0 0
Rotorua
Country [19] 0 0
Romania
State/province [19] 0 0
Bucuresti
Country [20] 0 0
Romania
State/province [20] 0 0
Cluj Napoca
Country [21] 0 0
Romania
State/province [21] 0 0
Cluj-napoca
Country [22] 0 0
Romania
State/province [22] 0 0
Craiova
Country [23] 0 0
Romania
State/province [23] 0 0
Floresti
Country [24] 0 0
Romania
State/province [24] 0 0
Iasi
Country [25] 0 0
Romania
State/province [25] 0 0
Ploiesti
Country [26] 0 0
Romania
State/province [26] 0 0
Timisoara
Country [27] 0 0
South Africa
State/province [27] 0 0
Cape Town
Country [28] 0 0
South Africa
State/province [28] 0 0
Centurion
Country [29] 0 0
South Africa
State/province [29] 0 0
Johannesburg
Country [30] 0 0
South Africa
State/province [30] 0 0
Port Elizabeth
Country [31] 0 0
Turkey
State/province [31] 0 0
Adana
Country [32] 0 0
Turkey
State/province [32] 0 0
Ankara
Country [33] 0 0
Turkey
State/province [33] 0 0
Edirne
Country [34] 0 0
Turkey
State/province [34] 0 0
Istanbul
Country [35] 0 0
Turkey
State/province [35] 0 0
Kocaeli

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
[email protected]
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/NCT05879822