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

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Uterine Cervical Neoplasms

Adenocarcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Vaginal Neoplasms

Vulvar Neoplasms

Uterine Neoplasms

Cystadenocarcinoma, Serous

Carcinosarcoma

Mixed Tumor, Mullerian

Adenocarcinoma, Mucinous

Cystadenocarcinoma

Ovarian Cancer

Ovarian Epithelial Cancer

Vaginal Cancer

Fallopian Tube Cancer

Adenocarcinoma of the Appendix

Malignant Mixed Mullerian Tumor

Vulvar Cancer

Antineoplastic Agents

Amino Acids

Axitinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Up to 6 doses of INCB099280 administered twice daily (BID) in combination with axitinib BID will be evaluated to identify dose(s) for further evaluation in the dose expansion phase of the study.

On completion of Part 1, participants will be enrolled in 1 of 2 disease-specific cohorts: Cohort 1: Adults with clear-cell gynecological cancers with at least 50% clear-cell histology whose disease progressed on or following at least 1 prior line of systemic chemotherapy and are not candidates for curative surgery or (chemo)radiation. Cohort 2: Adults with rare histological subtype epithelial cancers of the gynecological tract whose disease progressed on or following at least 1 prior line of systemic chemotherapy and are not candidates for curative surgery or (chemo)radiation. One or two doses may be selected from Part 1 for each cohort in the Part 2 Expansion.

Administered as specified in the treatment arm description

axitinib

Philomena Colucci

This study is being conducted to evaluate the safety and tolerability of INCB099280 in combination with axitinib and to assess the antitumor activity of INCB099280 in combination with axitinib. This study will only be open in the UK and EU.

The study consists of 2 parts. In the Part 1 dose-escalation, participants will be enrolled in up to 6 dose levels of INCB099280 administered in combination with axitinib. In the Part 2 dose expansion, participants will be enrolled into 1 of 2 disease-specific cohorts at the dose(s) identified in Part 1.

A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors

A Phase 1/2 Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors

Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.

Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

Number of participants with TEAEs leading to a dose modification (treatment interruption, dose reduction, and permanent discontinuation of either study drug).

Defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as determined by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Defined as the best overall response of CR, PR, or stable disease (SD) of at least 11 weeks from the start of treatment by investigator assessment per RECIST v1.1.

Defined as the time from the first CR or PR until disease progression by investigator assessment per RECIST v1.1 or death from any cause, whichever occurs earlier.

PK parameters will be calculated from the blood plasma concentrations of INCB099280 and axitinib using standard noncompartmental (model independent) PK methods.

Digestive System Diseases

Carcinoma, Hepatocellular

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

Liver Extracts

Study participants will receive the recommended phase II dose (400mg/kg) of INCB099280 orally on days 1 through 28 of each 28-day cycle until liver transplant.

Jennifer Walsh

Thomas Karasic, MD

This is a pilot safety study of the oral PD-L1 inhibitor INCB099280 in patients with HCC awaiting liver transplant.

Pre-Transplant INCBB099280 for Hepatocellular Carcinoma (HCC)

A Pilot Study of Neoadjuvant INCB099280 in Patients With Hepatocellular Carcinoma Awaiting Liver Transplant

Proportion of patients who undergo liver transplant who experience biopsy-proven acute cellular rejection of liver transplant using Banff Criteria within 1 month of liver transplantation that is at least possibly related to study therapy

Proportion of patients who undergo liver transplant who experience biopsy-proven acute cellular rejection of liver transplant using Banff Criteria within 3 month of liver transplantation

Proportion of patients who undergo liver transplant who experience biopsy-proven acute cellular rejection of liver transplant using Banff Criteria within 1 year of liver transplantation

Treatment-emergent adverse events graded using CTCAE v. 5.0

Proportion of patients outside of the Milan Criteria at study entry who undergo liver transplant

Proportion of patients undergoing liver transplant with a complete pathologic response on liver explant

Proportion of patients who undergo liver transplant without recurrence of hepatocellular carcinoma within 1 year after transplant

Proportion of patients who undergo liver transplant who are alive 1 year after transplant

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 INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors	NCT05949632	Advanced Solid ...	INCB099280 axitinib	18 Years -	Incyte Corporation
Pre-Transplant INCBB099280 for Hepatocellular Carcinoma (HCC)	NCT06337162	Hepatocellular ...	INCB099280	18 Years -	Abramson Cancer Center at Penn Medicine
Pre-Transplant INCBB099280 for Hepatocellular Carcinoma (HCC)	NCT06337162	Hepatocellular ...	INCB099280	18 Years -	Abramson Cancer Center at Penn Medicine
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 incb099280

Every month we try and update this database with for incb099280 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for incb099280

Every month we try and update this database with for incb099280 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for incb099280 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.