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Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors

Primary Purpose

Melanoma, Hepatocellular Carcinoma (HCC), Renal Cell Carcinoma (RCC)

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
INCB 99280 with Ipilimumab
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Prior systemic therapy, diagnoses and disease setting as follows: For Part 1 (dose escalation), and no history of treatment with anti-CTLA-4 or anti-PD-(L)1 therapy and one of the following, Unresectable or metastatic cutaneous melanoma, or Unresectable of metastatic Child-Pugh Class A NDD not eligible for surgical and/or locoregional therapy, or Intermediate or poor-risk advanced clear cell RCC, or MSI-H or dMMR metastatic CRC and able to provide fresh or archival tumor tissue for central confirmation of MSI-H or dMMR. For Part 2 (dose expansion), IO treatment -naïve, e.g., no prior receipt of an anti PD-1, anti-PD-L1 or PD-L1, anti-CTLA-4, GITR, LAG3, TIM3, OX-40, IL-2, 4-1BB or other immune modulator, and have not received prior systemic therapy and one of the following, Unresectable or metastatic Child-Pugh Class A HCC not eligible for surgical and/or locoregional therapy, or Intermediate - or poor-risk advanced clear cell RCC. ECOG performance score of 0 or 1. Life expectancy > 3 months, in the opinion of the investigator. Histologically confirmed solid tumors with measurable disease per RECIST v1.1. Exception: HCC may be diagnoses based on cross-sectional multiphasic imagining using the AASLD criteria. Willingness to avoid pregnancy or fathering children. Exclusion Criteria: Known history of an additional malignancy. Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease. Toxicity from prior therapy that has not recovered. Received thoracic radiation within 6 months of the first dose of study treatment. Participation in another interventional clinical study while receiving INCB099280. Impaired cardiac function of clinically significant cardiac disease. History of evidence of interstitial lung disease including non-infections pneumonitis. Presence of gastrointestinal condition that may affect drug absorption Any autoimmune disease requiring systemic treatment in the past 5 years. Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent Active infection requiring systemic therapy. History of organ transplantation, including allogeneic stem cell transplantation. Receipt of system antibiotics within 28 days of first dose of study treatment. Probiotic usage is prohibited during the screening and throughout the study treatment period. Received a live vaccine within 28 days of planned start of study drug. Laboratory values outside the Protocol-defined ranges. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Sites / Locations

  • Hgb - Hospital Giovanni Battista - Mae de Deus Center
  • Valkyrie Clinical TrialsRecruiting
  • UC Irvine Medical Center
  • Sharp Memorial Hospital
  • Henry Ford Health System
  • University of North Carolina At Chapel Hill
  • Alliance For Multispecialty Research LlcRecruiting
  • Cancer Research Sa
  • Box Hill Hospital
  • Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Câncer
  • Centro Regional Integrado de Oncologia
  • Fundacao Doutor Amaral Carvalho
  • Hospital de Cancer de Londrina
  • Oncocentro - Belo Horizonte
  • Hospital Sao Vicente de Paulo
  • Clinica Lacks - Unidade de Pesquisas Clinicas Em Oncologia (Upco)
  • Irmandade Da Santa Casa de Misericordia de Porto Alegre
  • Hospital de Clinicas de Porto Alegre
  • Hospital Nossa Senhora Da Conceicao
  • Hospital Das Clínicas Fmrp-Usp
  • Instituto de Oncologia Saint Gallen
  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
  • A. C. Camargo Cancer Center
  • Princess Margaret Cancer Center
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Health Pharma Professional Research S.A. de C.V.
  • Cancer Clinical Trials
  • Preparaciones Oncologicas, S.C
  • Cryptex Investigacion Clinica S.A. de C.V.
  • Accelerium S de Rl de Cv
  • I Can Oncology Center S.A. de C.V.
  • Clinical Medical Research S.C.
  • Centro Potosino de Investigación Medica S.C.
  • Centro Medico Zambrano Hellion
  • Centro de Investigacion Clinica de Alta Especialidad 'Cicae'
  • Vestre Viken Hf Drammen Sykehus
  • Akershus University Hospital
  • Narodny Onkologicky Ustav
  • Vychodoslovensky Onkologicky Ustav A.S. Oddelenie Radiacnej Onkologie
  • Cancercare Rondebosch Oncology Centre
  • Johese Clinical Research: Midstream
  • Wits Clinical Research
  • Mary Potter Oncology Centre
  • Skaenes Universitetssjukhus Lund
  • Karolinska Universitessjukhuset - Solna
  • Adana Sehir Hastanesi
  • Hacettepe University Medical Faculty
  • Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital
  • Ankara City Hospital
  • Istanbul University Istanbul Medical Faculty

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose Escalation

Dose Expansion

Arm Description

Participants with RCC and MSI-H/dMMR CRC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 1 mg/kg Q3 weeks Participants with Melanoma and HCC will receive 1 of 2 doses of INCB099280 BID with up to 4 doses of 3 ipilimumab 3 mg/kg Q3 weeks

Participants with RCC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 1 mg/kg Q3 weeks of ipilimumab Participants with HCC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 3 mg/kg Q3 weeks of ipilimumab

Outcomes

Primary Outcome Measures

Occurence of DLTs
Incidence of TEAEs
Assessed by physical examinations, changes in vital signs and ECGs, and analysis of clinical laboratory samples.
Incidence of TEAEs leading to dose interruption, dose reduction, or discontinuation of either of the study drugs

Secondary Outcome Measures

Concentration of INCB099280 in plasma
Objective response
Defined as having a best overall response of complete response or partial response by investigator assessment per RECIST v1.1.
Disease control
Defined as having a best overall response of complete response or partial response, or stable disease of ≥ 15 weeks after initiation of study treatment, by investigator assessment per RECIST v1.1.
Duration of Response
Defined as the time from the earliest date of CR or PR until the earliest date of disease progression (by investigator assessment per RECIST v1.1) or death due to any cause if occurring sooner than progression.

Full Information

First Posted
June 9, 2023
Last Updated
October 3, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05909995
Brief Title
Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors
Official Title
A Phase 1 Study of INCB099280 in Combination With Ipilimumab in Participants With Select Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2023 (Actual)
Primary Completion Date
June 27, 2025 (Anticipated)
Study Completion Date
July 27, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to characterize the safety, tolerability, PK, and efficacy of INCB 99280 in combination with ipilimumab in participants with select solid tumors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Hepatocellular Carcinoma (HCC), Renal Cell Carcinoma (RCC), Microsatellite Instability - High (MSI-H), Mismatch Repair Deficient (dMMR), Colorectal Carcinoma (CRC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
Participants with RCC and MSI-H/dMMR CRC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 1 mg/kg Q3 weeks Participants with Melanoma and HCC will receive 1 of 2 doses of INCB099280 BID with up to 4 doses of 3 ipilimumab 3 mg/kg Q3 weeks
Arm Title
Dose Expansion
Arm Type
Experimental
Arm Description
Participants with RCC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 1 mg/kg Q3 weeks of ipilimumab Participants with HCC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 3 mg/kg Q3 weeks of ipilimumab
Intervention Type
Drug
Intervention Name(s)
INCB 99280 with Ipilimumab
Intervention Description
Dose Escalation and expansion of INCB 99280 with Ipilimumab
Primary Outcome Measure Information:
Title
Occurence of DLTs
Time Frame
2 Years
Title
Incidence of TEAEs
Description
Assessed by physical examinations, changes in vital signs and ECGs, and analysis of clinical laboratory samples.
Time Frame
2 Years
Title
Incidence of TEAEs leading to dose interruption, dose reduction, or discontinuation of either of the study drugs
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Concentration of INCB099280 in plasma
Time Frame
2 Years
Title
Objective response
Description
Defined as having a best overall response of complete response or partial response by investigator assessment per RECIST v1.1.
Time Frame
2 Years
Title
Disease control
Description
Defined as having a best overall response of complete response or partial response, or stable disease of ≥ 15 weeks after initiation of study treatment, by investigator assessment per RECIST v1.1.
Time Frame
2 Years
Title
Duration of Response
Description
Defined as the time from the earliest date of CR or PR until the earliest date of disease progression (by investigator assessment per RECIST v1.1) or death due to any cause if occurring sooner than progression.
Time Frame
2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Prior systemic therapy, diagnoses and disease setting as follows: For Part 1 (dose escalation), and no history of treatment with anti-CTLA-4 or anti-PD-(L)1 therapy and one of the following, Unresectable or metastatic cutaneous melanoma, or Unresectable of metastatic Child-Pugh Class A NDD not eligible for surgical and/or locoregional therapy, or Intermediate or poor-risk advanced clear cell RCC, or MSI-H or dMMR metastatic CRC and able to provide fresh or archival tumor tissue for central confirmation of MSI-H or dMMR. For Part 2 (dose expansion), IO treatment -naïve, e.g., no prior receipt of an anti PD-1, anti-PD-L1 or PD-L1, anti-CTLA-4, GITR, LAG3, TIM3, OX-40, IL-2, 4-1BB or other immune modulator, and have not received prior systemic therapy and one of the following, Unresectable or metastatic Child-Pugh Class A HCC not eligible for surgical and/or locoregional therapy, or Intermediate - or poor-risk advanced clear cell RCC. ECOG performance score of 0 or 1. Life expectancy > 3 months, in the opinion of the investigator. Histologically confirmed solid tumors with measurable disease per RECIST v1.1. Exception: HCC may be diagnoses based on cross-sectional multiphasic imagining using the AASLD criteria. Willingness to avoid pregnancy or fathering children. Exclusion Criteria: Known history of an additional malignancy. Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease. Toxicity from prior therapy that has not recovered. Received thoracic radiation within 6 months of the first dose of study treatment. Participation in another interventional clinical study while receiving INCB099280. Impaired cardiac function of clinically significant cardiac disease. History of evidence of interstitial lung disease including non-infections pneumonitis. Presence of gastrointestinal condition that may affect drug absorption Any autoimmune disease requiring systemic treatment in the past 5 years. Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent Active infection requiring systemic therapy. History of organ transplantation, including allogeneic stem cell transplantation. Receipt of system antibiotics within 28 days of first dose of study treatment. Probiotic usage is prohibited during the screening and throughout the study treatment period. Received a live vaccine within 28 days of planned start of study drug. Laboratory values outside the Protocol-defined ranges. Other protocol-defined Inclusion/Exclusion Criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (US)
Phone
1.855.463.3463
Email
medinfo@incyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (ex-US)
Phone
+800 00027423
Email
eumedinfo@incyte.com
Facility Information:
Facility Name
Hgb - Hospital Giovanni Battista - Mae de Deus Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Valkyrie Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Individual Site Status
Recruiting
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of North Carolina At Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Withdrawn
Facility Name
Alliance For Multispecialty Research Llc
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Research Sa
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
05000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
03128
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Câncer
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Centro Regional Integrado de Oncologia
City
Fortaleza
ZIP/Postal Code
60336-045
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Fundacao Doutor Amaral Carvalho
City
JAÚ
ZIP/Postal Code
17210-120
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Hospital de Cancer de Londrina
City
Londrina
ZIP/Postal Code
86015-520
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Oncocentro - Belo Horizonte
City
Nova Lima
ZIP/Postal Code
34006
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Hospital Sao Vicente de Paulo
City
Passo Fundo
ZIP/Postal Code
99010-080
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Clinica Lacks - Unidade de Pesquisas Clinicas Em Oncologia (Upco)
City
Pelotas
ZIP/Postal Code
96020-080
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Irmandade Da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Hospital Nossa Senhora Da Conceicao
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Hospital Das Clínicas Fmrp-Usp
City
Ribeirão Preto
ZIP/Postal Code
14048-900
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Instituto de Oncologia Saint Gallen
City
Santa Cruz Do Sul
ZIP/Postal Code
96810-110
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
City
SAO JOSE RIO Preto
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
A. C. Camargo Cancer Center
City
São Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
KS009
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Health Pharma Professional Research S.A. de C.V.
City
Ciudad de México
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Cancer Clinical Trials
City
Guadalajara
ZIP/Postal Code
44657
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Preparaciones Oncologicas, S.C
City
Leon
ZIP/Postal Code
C.P. 37178
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Cryptex Investigacion Clinica S.A. de C.V.
City
Mexico
ZIP/Postal Code
06100
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Accelerium S de Rl de Cv
City
Monterrey
ZIP/Postal Code
64000
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
I Can Oncology Center S.A. de C.V.
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Clinical Medical Research S.C.
City
Orizaba
ZIP/Postal Code
94300
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Centro Potosino de Investigación Medica S.C.
City
San Luis Potosi
ZIP/Postal Code
78250
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Centro Medico Zambrano Hellion
City
San Pedro Garza Garcia
ZIP/Postal Code
66278
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Centro de Investigacion Clinica de Alta Especialidad 'Cicae'
City
Torreon
ZIP/Postal Code
27010
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Vestre Viken Hf Drammen Sykehus
City
Drammen
ZIP/Postal Code
03004
Country
Norway
Individual Site Status
Not yet recruiting
Facility Name
Akershus University Hospital
City
Lorenskog
ZIP/Postal Code
01478
Country
Norway
Individual Site Status
Not yet recruiting
Facility Name
Narodny Onkologicky Ustav
City
Bratislava
ZIP/Postal Code
83310
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Vychodoslovensky Onkologicky Ustav A.S. Oddelenie Radiacnej Onkologie
City
Kosice
ZIP/Postal Code
04191
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Cancercare Rondebosch Oncology Centre
City
Cape Town
ZIP/Postal Code
07700
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Johese Clinical Research: Midstream
City
Centurion
ZIP/Postal Code
01692
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Wits Clinical Research
City
Johannesburg
ZIP/Postal Code
02193
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Mary Potter Oncology Centre
City
Pretoria
ZIP/Postal Code
00181
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Skaenes Universitetssjukhus Lund
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Karolinska Universitessjukhuset - Solna
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Adana Sehir Hastanesi
City
Adana
ZIP/Postal Code
01230
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital
City
Ankara
ZIP/Postal Code
06105
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Ankara City Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Learn more about this trial

Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors

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