Trial Review

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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:
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
Trial website
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
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


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/ct2/show/NCT05909995