Protocol Title: open label, phase 1 study of INC 280 in combination with Ipilimumab in participants with advanced or metastatic solid tumors

Sponsor: Incyte Corporation

Protocol Number: INCB 99280 – 205

Key Criteria

§  Dose escalation specific:
·         Unresectable/metastatic cutaneous melanoma
·         Unresectable/metastatic hepatocellular carcinoma (Child-Pugh Class A) not eligible for surgical/locoregional therapy and without encephalopathy within past 6 months (No use of Rifamixin or lactulose)
·         Intermediate/poor-risk advanced Clear cell renal cell carcinoma
·         MSI-H or dMMR metastatic colorectal carcinoma
§  Dose expansion specific:
·         Immunotherapy treatment naive and have not received prior systemic therapy
·         Either unresectable/metastatic HCC not eligible for surgical/locoregional therapy OR intermediate/poor-risk advanced clear cell RCC
§  Measurable disease per RECIST v1.1
§  Life expectancy > 3 months
Excluded if
·         Known history of additional malignancy (except if patient has received potentially curative therapy without recurrence for 3 years since starting therapy)
·         CNS metastases requiring treatment
·         Leptomeningeal disease
·         Residual toxicity from prior therapy
·         Received thoracic radiation within 6 months before first dose
·         History of organ transplant, allogenic stem cell transplant

Talking Points

§  Study drug: Elacestrant acts as a selective estrogen receptor degrader
§  Route of administration: PO, tablets
§  Indication: patients with ER+/HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapy and NO prior CDK4/CDK6 inhibitors in the metastatic setting
§  Study design: This study will assess the efficacy and safety of elacestrant in patients with ER+/HER2- advanced/metastatic breast cancer who have not received prior CDK4/6 inhibitors in the metastatic setting
§  Treatment duration: treatment will continue until disease progression, death, development of unacceptable toxicity, withdrawal of consent, or other reasons. Average treatment duration is estimated to be 6 months§  Investigational drug class: PDL1 inhibitor antibody
§  Therapeutic context: Patients with recurrent or advanced/metastatic solid tumors who have received standard therapy or have not received standard therapy and are immunotherapy treatment naïve
§  Study design: Study drug in combination with Ipilimumab
§  Treatment duration: up to 2 years as long as patient is receiving benefit and has not met any criteria for withdrawal
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