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

Skin and Connective Tissue Diseases

Skin Neoplasms

Skin Diseases

Antineoplastic Agents

Immunomodulating Agents

Cemiplimab

Antineoplastic Agents, Immunological

Participants have locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC

Participants will undergo baseline imaging, followed by two doses of neoadjuvant cemiplimab at a dose of 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days). Then, participants will receive concurrent cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) concurrently with RT to 70 Gy in 35 fractions over 7 weeks. Thereafter, participants will receive 38 weeks of cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) for a cumulative total of 12 months of cemiplimab.

Participants will receive radiotherapy to 70 Gy in 35 fractions over 7 weeks concurrently with cemiplimab

Radiotherapy

Christopher Barker, MD

Lara Dunn, MD

Ryan Lanning, MD, PhD

Evan Wuthrick, MD

Zachary Buchwald, MD, PhD

Shlomo Koyman, MD

Thomas Galloway, MD

Bhisham Chere, MD

Upendra Parvathaneni, MD

The purpose of the study is to see if the combination of radiation therapy and cemiplimab immunotherapy is an effective treatment for people with locally advanced, unresectable CSCC.

A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer

A Phase II, Multicenter, Single-Arm Clinical Trial of Radiotherapy and CeMiPlimAb: Rwlc ImmunoTherapy for Locally Advanced, Unresectable Cutaneous Squamous Cell Carcinoma: RAMPART

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

The primary endpoint for this study is disease free survival at 18 months (week 78 +/- 3 weeks) after starting cemiplimab.

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
A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer	NCT05574101	Cutaneous Squam... Skin Cancer Squamous Cell C... Locally Advance... Locally Advance... Locally Advance... Locally Advance...	Cemiplimab Radiotherapy	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer	NCT05574101	Cutaneous Squam... Skin Cancer Squamous Cell C... Locally Advance... Locally Advance... Locally Advance... Locally Advance...	Cemiplimab Radiotherapy	18 Years -	Memorial Sloan Kettering Cancer Center
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 locally advanced cutaneous squamous cell carcinoma