Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

epacadostat will be administered in combination with retifanlimab.

retifanlimab will be administered as monotherapy.

epacadostat will be administered as monotherapy.

retifanlimab will be administered in combination with INCAGN02385.

retifanlimab will be administered in combination with INCAGN02385 and INCAGN02390.

retifanlimab will be administered via IV over 30 minutes (+ 15 min) on Day 1 of each 28-day cycle, up to 3 cycles,

retifanlimab

epacadostat will be administered daily twice daily orally up to and including day of surgery.

epacadostat

INCAGN02385 will be administered via IV over 30 minutes (-5/+10 min) every 2 weeks.

INCAGN02385

INCAGN02390 will be administered via IV over 30 minutes (-5/+10 min) every 2 weeks.

INCAGN02390

Diane Hershock, MD

This is a multicenter, open-label, randomized, Phase 2 umbrella study of various neoadjuvant treatment combinations in participants who have muscle-invasive urothelial carcinoma of the bladder and are cisplatin-ineligible or refusing cisplatin therapy and awaiting radical cystectomy.

Participants will be stratified based on Programmed cell Death-Ligand 1 (PD-L1) Combined Positive Score ( CPS) \< 10 and PD-L1 CPS ≥ 10.

An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma

An Open-Label, Randomized, Phase 2, Umbrella Study to Investigate the Biological Rational of Various Neoadjuvant Therapies for Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Cisplatin-Ineligible or Refuse Cisplatin Therapy and Undergoing Radical Cystectomy

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 change from baseline in CD8+ lymphocytes within resected tumor

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 30 days after last dose of study drug.

Defined as percentage of participants with absence of tumor as well as no observed tumor in the nodes post neoadjuvant therapy and pre-surgery.

Defined as absence of tumor cells determined pre- surgery or in-Situ absence of tumor cells in the nodes and no metastases.

Incyte Corporation

Symptoms and General Pathology

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Recurrence

Head and Neck Neoplasms

Neoplasms, Squamous Cell

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Retifanlimab will be administered intravenously every 4 weeks. Placebos for INCAGN02385 and INCAGN02390 will be administered intravenously every 2 weeks.

Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks.

Retifanlimab plus INCAGN02385 and INCAGN02390 will be administered intravenously. Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and INCAGN02390 will be administered every 2 weeks.

Retifanlimab 500mg will be administered intravenously every 4 weeks.

Retifanlimab

INCAGN02385 350mg will be administered intravenously every 2 weeks.

INCAGN02390 400 mg will be administered intravenously every 2 weeks.

Placebo will be administered intravenously.

Placebo

Incyte Corporation Call Center (US)

Incyte Corporation Call Center (ex-US)

The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).

Patients will be randomized to 1 of 3 treatment groups.

Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

A Randomized, Double-Blind, Multicenter, Phase 2 Study of Retifanlimab in Combination With INCAGN02385 (Anti-LAG-3) and INCAGN02390 (Anti-TIM-3) as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

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 interval between the date of first dose of study treatment and the earliest date of disease progression, based on investigator assessment per RECIST v1.1, or death due to any cause.

Defined as having a Complete Response (CR) or Partial Response (PR), determined based on investigator assessment per RECIST v1.1.

Defined as the time from earliest date of disease response (CR or PR) until earliest date of disease progression, based on investigator assessment per RECIST v1.1, or death from any cause if occurring sooner than progression.

Defined as having CR, PR, or SD (≥ 6 months) as best response, based on investigator assessment per RECIST v1.1.

Defined as the interval between the date of the date of first dose of study treatment until death due to any cause.

TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug

Incyte Biosciences International Sàrl

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Part 1 will confirm the safety of INCAGN02385 and INCAGN02390 when used in combination. INCAGN02385 will be administered first intravenously followed by INCAGN02390.

Part 2 will confirm the safety of the triple combination of INCAGN02385 + INCAGN02390 + INCMGA00012, following confirmation of the safety of the doublet in Part 1. INCAGN02385 will be administered first intravenously followed by INCAGN02390 and INCMGA00012.

Phase 2 will determine preliminary efficacy and proof of concept for the combination of INCAGN02385 + INCAGN02390 + INCMGA00012. INCAGN02385 will be administered first intravenously followed by INCAGN02390 and INCMGA00012

Part 1 will confirm the safety of INCAGN02385 + INCAGN02390 + INCMGA00012 when used in combination.

Part 1 will confirm the safety of INCAGN02385 + INCAGN02390 + INCMGA00012 in combination.

INCMGA00012.

The study will determine Recommended Phase 2 Dose for all study drugs, based on the safety and tolerability of the following combinations: INCAGN02385 + INCAGN02390 and INCAGN02385 + INCAGN02390 + INCMGA00012.

Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Select Advanced Malignancies

A Phase 1-2 Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Select Advanced Malignancies

Defined as the percentage of participants having a Complete Response or Partial Response, will be determined by investigator assessment of radiographic disease assessments per RECIST v1.1.

Defined as the time from earliest date of disease response (CR or PR) until earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1, or death from any cause, if occurring sooner than progression.

Defined as percentage of participants having CR, PR, or SD as best on-study response.

Defined as the time from date of first dose of study treatment until the earliest date of disease progression, as determined by investigator assessment of objective radiographic disease per RECIST v1.1

Defined as the time from date of first dose of study treatment until the earliest date of disease progression, as determined by investigator assessment of objective radiographic disease per RECIST v1.1.

Defined as percentage of participants having CR, PR, or SD as best on-study response

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously

Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat (IDO1 inhibitor)

Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral pemigatininb (FGFR 1,2,3 inhibitor)

Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat

Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab in combination with INCAGN02385 and INCAGN02390 intravenously

INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.

epacadostat will be administered orally BID.

pemigatinib will be administered orally QD.

pemigatinib

INCAGN2385 will be administered every 2 weeks

INCAGN2390 will be administered every 2 weeks

Mark Cornfield

This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in participants who have advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy. retifanlimab will be administered as monotherapy or in combination with other immunotherapy or targeted agents.

Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy.

An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)

Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee

Defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause.

Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.

Defined as the time from the first dose of study treatment until death due to any cause.

Defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause.

Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma	NCT04586244	Urothelial Carc...	retifanlimab epacadostat INCAGN02385 INCAGN02390	18 Years -	Incyte Corporation
An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma	NCT04586244	Urothelial Carc...	retifanlimab epacadostat INCAGN02385 INCAGN02390	18 Years -	Incyte Corporation
Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck	NCT05287113	Head and Neck C...	Retifanlimab INCAGN02385 INCAGN02390 Placebo	18 Years - 99 Years	Incyte Corporation
Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck	NCT05287113	Head and Neck C...	Retifanlimab INCAGN02385 INCAGN02390 Placebo	18 Years - 99 Years	Incyte Corporation
Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Select Advanced Malignancies	NCT04370704	Melanoma	INCAGN02385 INCAGN02390 INCMGA00012.	18 Years -	Incyte Corporation
Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy.	NCT04463771	Endometrial Can...	retifanlimab epacadostat pemigatinib INCAGN02385 INCAGN02390	18 Years -	Incyte Corporation

Spots Global Cancer Trial Database for incagn02385

Every month we try and update this database with for incagn02385 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 incagn02385

Every month we try and update this database with for incagn02385 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 incagn02385 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.