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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05909995




Registration number
NCT05909995
Ethics application status
Date submitted
9/06/2023
Date registered
18/06/2023
Date last updated
10/05/2024

Titles & IDs
Public title
Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors
Scientific title
A Phase 1 Study of INCB099280 in Combination With Ipilimumab in Participants With Select Solid Tumors
Secondary ID [1] 0 0
2023-503243-34-00
Secondary ID [2] 0 0
INCB 99280-205
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Hepatocellular Carcinoma (HCC) 0 0
Renal Cell Carcinoma (RCC) 0 0
Microsatellite Instability - High (MSI-H) 0 0
Mismatch Repair Deficient (dMMR) 0 0
Colorectal Carcinoma (CRC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - INCB 99280 with Ipilimumab

Experimental: Dose Escalation - Participants with RCC and MSI-H/dMMR CRC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 1 mg/kg Q3 weeks
Participants with Melanoma and HCC will receive 1 of 2 doses of INCB099280 BID with up to 4 doses of 3 ipilimumab 3 mg/kg Q3 weeks

Experimental: Dose Expansion - Participants with RCC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 1 mg/kg Q3 weeks of ipilimumab
Participants with HCC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 3 mg/kg Q3 weeks of ipilimumab


Treatment: Drugs: INCB 99280 with Ipilimumab
Dose Escalation and expansion of INCB 99280 with Ipilimumab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurence of DLTs
Timepoint [1] 0 0
2 Years
Primary outcome [2] 0 0
Incidence of TEAEs
Timepoint [2] 0 0
2 Years
Primary outcome [3] 0 0
Incidence of TEAEs leading to dose interruption, dose reduction, or discontinuation of either of the study drugs
Timepoint [3] 0 0
2 Years
Secondary outcome [1] 0 0
Concentration of INCB099280 in plasma
Timepoint [1] 0 0
2 Years
Secondary outcome [2] 0 0
Objective response
Timepoint [2] 0 0
2 Years
Secondary outcome [3] 0 0
Disease control
Timepoint [3] 0 0
2 Years
Secondary outcome [4] 0 0
Duration of Response
Timepoint [4] 0 0
2 Years

Eligibility
Key inclusion criteria
- Prior systemic therapy, diagnoses and disease setting as follows:

- For Part 1 (dose escalation), and no history of treatment with anti-CTLA-4 or
anti-PD-(L)1 therapy and one of the following,

- Unresectable or metastatic cutaneous melanoma, or

- Unresectable of metastatic Child-Pugh Class A NDD not eligible for surgical
and/or locoregional therapy, or

- Intermediate or poor-risk advanced clear cell RCC, or

- MSI-H or dMMR metastatic CRC and able to provide fresh or archival tumor
tissue for central confirmation of MSI-H or dMMR.

- For Part 2 (dose expansion), IO treatment -naïve, e.g., no prior receipt of an
anti PD-1, anti-PD-L1 or PD-L1, anti-CTLA-4, GITR, LAG3, TIM3, OX-40, IL-2, 4-1BB
or other immune modulator, and have not received prior systemic therapy and one
of the following,

- Unresectable or metastatic Child-Pugh Class A HCC not eligible for surgical
and/or locoregional therapy, or

- Intermediate - or poor-risk advanced clear cell RCC.

- ECOG performance score of 0 or 1.

- Life expectancy > 3 months, in the opinion of the investigator.

- Histologically confirmed solid tumors with measurable disease per RECIST v1.1.

- Exception: HCC may be diagnoses based on cross-sectional multiphasic
imagining using the AASLD criteria.

- 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.

- 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 of clinically significant cardiac disease.

- History of evidence of interstitial lung disease including non-infections pneumonitis.

- Presence of gastrointestinal condition 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 system antibiotics within 28 days of first dose of study treatment.

- Probiotic usage is prohibited during the screening and throughout the study treatment
period.

- Received a live vaccine within 28 days of 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
Non-randomised 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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/07/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Cancer Research Sa - Adelaide
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 0 0
05000 - Adelaide
Recruitment postcode(s) [2] 0 0
03128 - Box Hill
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
Brazil
State/province [5] 0 0
Londrina
Country [6] 0 0
Brazil
State/province [6] 0 0
Nova Lima
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Mexico
State/province [9] 0 0
Guadalajara
Country [10] 0 0
Norway
State/province [10] 0 0
Drammen
Country [11] 0 0
Slovakia
State/province [11] 0 0
Bratislava

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to characterize the safety, tolerability, PK, and efficacy of
INCB 99280 in combination with ipilimumab in participants with select solid tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05909995
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05909995