A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint… (NCT05879822) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive
Brazil73 participantsStarted 2023-10-30
Plain-language summary
This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced solid tumors.
Who can participate
Age range18 Years
SexALL
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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 advanc…
What they're measuring
1
Objective response rate (ORR)
Timeframe: Up to 2 years
2
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to 2 years 3 months
3
Number of participants with TEAEs leading to dose modification or discontinuation