MelanomaPhase 1NCT05909995
Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors
A Phase 1 study testing INCB 99280 with Ipilimumab in people with Melanoma and Hepatocellular Carcinoma (HCC), run by Incyte Corporation at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Hepatocellular Carcinoma (HCC), Renal Cell Carcinoma (RCC)
- What is being tested?
- INCB 99280 with Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 29 Aug 2023to 11 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States5 sites
Henry Ford Health System
Detroit, Michigan, 48202
Alliance For Multispecialty Research Llc
Knoxville, Tennessee, 37920
Valkyrie Clinical Trials
Los Angeles, California, 90067
UC Irvine Medical Center
Orange, California, 92868
Sharp Memorial Hospital
San Diego, California, 92123
South Africa2 sites
Johese Clinical Research: Midstream
Centurion, 01692
Mary Potter Oncology Centre
Pretoria, 00181
About this study
Official title: A Phase 1 Study of INCB099280 in Combination With Ipilimumab in Participants With Select Solid Tumors
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.
- Conditions
- Melanoma, Hepatocellular Carcinoma (HCC), Renal Cell Carcinoma (RCC), Microsatellite Instability - High (MSI-H), Mismatch Repair Deficient (dMMR), Colorectal Carcinoma (CRC)
- Being tested
- INCB 99280 with Ipilimumab
- Medical subject headings
- Melanoma, Carcinoma, Hepatocellular, Carcinoma, Renal Cell, Turcot syndrome, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB 99280 with IpilimumabDrug
Dose Escalation and expansion of INCB 99280 with Ipilimumab
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | * 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 Receives: Drug: INCB 99280 with Ipilimumab |
| Dose Expansion | Experimental | * 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 Receives: Drug: INCB 99280 with Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of DLTs
Measured: 2 Years
Incidence of TEAEs
Assessed by physical examinations, changes in vital signs and ECGs, and analysis of clinical laboratory samples.
Measured: 2 Years
Incidence of TEAEs leading to dose interruption, dose reduction, or discontinuation of either of the study drugs
Measured: 2 Years
Secondary outcomes (4)
Concentration of INCB099280 in plasma
Measured: 2 Years
Objective response
Defined as having a best overall response of complete response or partial response by investigator assessment per RECIST v1.1.
Measured: 2 Years
Disease control
Defined as having a best overall response of complete response or partial response, or stable disease of ≥ 15 weeks after initiation of study treatment, by investigator assessment per RECIST v1.1.
Measured: 2 Years
Duration of Response
Defined as the time from the earliest date of CR or PR until the earliest date of disease progression (by investigator assessment per RECIST v1.1) or death due to any cause if occurring sooner than progression.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start29 Aug 2023
- Primary completion19 Sep 2024
- Study completion11 Nov 2024
Why it stopped: This was a strategic business decision. There were no safety concerns contributing to this decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909995
- Sponsor's protocol ID
- INCB 99280-205
- Other IDs
- 2023-503243-34-00, 2023
- Status last verified
- Feb 2025
- First submitted
- 9 Jun 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of INCB099280 in Combination With Ipilimumab in Participants With Select Solid Tumors
- ClinicalTrials.gov ID
- NCT05909995
- Acronym / sponsor ID
- INCB 99280-205
- Conditions
- Melanoma, Hepatocellular Carcinoma (HCC), Renal Cell Carcinoma (RCC), Microsatellite Instability - High (MSI-H), Mismatch Repair Deficient (dMMR), Colorectal Carcinoma (CRC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This was a strategic business decision. There were no safety concerns contributing to this decision.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: INCB 99280 with Ipilimumab* 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 |
| Dose Expansion | Experimental | Drug: INCB 99280 with Ipilimumab* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Prior systemic therapy, diagnoses and disease setting as follows:
Key exclusion criteria (17 listed)
- 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.
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 |
|---|---|---|
| INCB 99280 with IpilimumabDose Escalation and expansion of INCB 99280 with Ipilimumab | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Occurence of DLTs
Time frame: 2 Years
Incidence of TEAEs
Time frame: 2 Years
Assessed by physical examinations, changes in vital signs and ECGs, and analysis of clinical laboratory samples.
Incidence of TEAEs leading to dose interruption, dose reduction, or discontinuation of either of the study drugs
Time frame: 2 Years
4 secondary outcomes
Concentration of INCB099280 in plasma
Time frame: 2 Years
Objective response
Time frame: 2 Years
Disease control
Time frame: 2 Years
Duration of Response
Time frame: 2 Years
Results and safety
The study was stopped early (reason given: This was a strategic business decision. There were no safety concerns contributing to this decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCB 99280 with Ipilimumab in people with Melanoma and Hepatocellular Carcinoma (HCC), run by Incyte Corporation at 8 sites in 3 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 14 inclusion and 17 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 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, South Africa, Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This was a strategic business decision. There were no safety concerns contributing to this decision.). Results are not available in the source record.
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?
Occurence of DLTs (time frame: 2 Years). The study lists 3 primary outcomes in all. 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 18 Feb 2025.