Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors
Melanoma, Hepatocellular Carcinoma (HCC), Renal Cell Carcinoma (RCC)
About this trial
This is an interventional treatment trial for Melanoma
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.
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
Experimental
Experimental
Dose Escalation
Dose Expansion
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