Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

All Drugs and Chemicals

Antibodies

Immunoglobulins

Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.

Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.

Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years.

Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years.

Administered as specified in the treatment arm description.

INCB099280

Incyte Corporation Call Center (US)

Incyte Corporation Call Center (ex-US)

Incyte Medical Monitor

This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced Cutaneous Squamous Cell Carcinoma.

The study consists of 2 parts. In Part 1, participants with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC will be randomized 1:1:1 to INCB099280 Dose 1, Dose 2, or Dose 3. In Part 2, one dose level identified from Part 1 will be expanded to enroll additional participants with metastatic cSCC and locally advanced cSCC.

A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma

A Phase 2 Study Evaluating INCB099280 in Participants With Advanced Squamous Cell Carcinoma

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

Defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as determined by the blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or composite criteria for metastatic cSCC and per World Health Organization (WHO) criteria for locally advanced cSCC.

Defined as any Adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurs first.

Number of participants with TEAEs leading to dose modification or discontinuation.

Defined as the percentage of participants with the best overall response of CR or PR, or stable disease (SD), after a minimum of 15 weeks following the initiation of study treatment as determined by the BICR per RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC.

Defined as the time from the earliest date of confirmed CR or PR to the earliest date of disease progression, as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC or death due to any cause if occurring sooner than progression.

Defined as the time from the date of first dose to the earliest date of confirmed CR or PR as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC.

Defined as the time from the date of first dose to the earliest date of disease progression as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC or death due to any cause if occurring sooner than progression.

Defined as the time from the date of first dose to death due to any cause.

Incyte Corporation

Infections

Skin and Connective Tissue Diseases

Virus Diseases

Skin Neoplasms

Antineoplastic Agents

Cemiplimab

Antineoplastic Agents, Immunological

Cemiplimab administered intravenously every 3 weeks in combination with RP1 administered as an intratumoral injection every 3 weeks

Cemiplimab administered intravenously as a single therapy every 3 weeks

Sumera Raoof, MD

Jeannie Hou, MD

To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review.

RP1 is a selectively replication competent herpes simplex virus type 1(HSV-1). This is a Phase 1/2, open-label, multicenter repeat-dosing study of RP1 alone and in combination with nivolumab in patients with advanced malignancies, and contains both single agent dose escalation, dose expansion to include nivolumab, and the combination in multiple Phase 2 cohorts in individual tumor types.

Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer

A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination With RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma	NCT05888844	Cutaneous Squam...	INCB099280	18 Years -	Incyte Corporation
Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer	NCT04050436	Cutaneous Squam... Advanced Cutane... Metastatic Cuta...	Cemiplimab RP1	18 Years -	Replimune Inc.
Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer	NCT04050436	Cutaneous Squam... Advanced Cutane... Metastatic Cuta...	Cemiplimab RP1	18 Years -	Replimune Inc.
A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma	NCT05888844	Cutaneous Squam...	INCB099280	18 Years -	Incyte Corporation

Spots Global Cancer Trial Database for metastatic cutaneous squamous cell carcinoma