Clinical trial NCT04629339: Study of INCB086550 in Select Solid Tumors
Official title: A Phase 2 Study of INCB086550 (Oral PD-L1 Inhibitor) in Participants Who Are Immune Checkpoint Inhibitor-Naïve With Selected Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Urothelial Cancer
Renal Cell Carcinoma
Hepatocellular Carcinoma
Melanoma
Keywords: checkpoint inhibitor naive
Metastatic
PD-L1
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2020-11-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label, nonrandomized study to evaluate the efficacy and safety of INCB086550, a first-in-class oral inhibitor of PD-L1, as initial immune checkpoint inhibitor therapy in participants with select solid tumors


Eligibility criteria: Inclusion Criteria:

* Ability to comprehend and willingness to sign a written ICF for the study.
* Participants with following tumor types : non small cell lung cancer, renal cell carcinoma, urothelial carcinoma, hepatocellular carcinoma and melanoma
* Measurable disease per RECIST v1.1.
* ECOG performance status of 0 to 1 for all tumor types. Urothelial carcinoma allows ECOG of 0 to 2.
* Histologically or cytologically confirmed disease-specific diagnosis as per protocol.
* Willingness to avoid pregnancy or fathering children

Exclusion Criteria:

* Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL2, 4-1BB, CAR-T).
* Receipt of any anticancer therapy or participation in another interventional clinical study.
* Radiotherapy within 14 days of first dose of study treatment.
* Concomitant treatment with moderate and potent CYP3A4/CYP3A5 inhibitors or inducers.
* Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of anemia not requiring transfusion support and any grade of alopecia). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with the medical monitor.
* Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
* Participants with laboratory values outside of protocol defined ranges Active malignancy of a type not included in the study population requiring treatment.
* Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\> 10 mg of prednisone or equivalent).
* Evidence of interstitial lung disease or active, noninfectious pneumonitis.
* Untreated or known active CNS metastases and/or carcinomatous meningitis.
* With the exception of participants with HCC, known active HAV, HBV, or HCV infection, as defined by elevated transaminases with the following serology: positivity for HAV IgM antibody, anti-HCV, anti-HBc IgG or IgM, or HBsAg (in the absence of prior immunization).
* Active infection requiring systemic therapy.
* Receipt of systemic antibiotics within 28 days of first dose of study treatment
* Probiotic usage during screening and throughout the study treatment period.
* Participants who are known to be HIV-positive.
* Participants with impaired cardiac function or clinically significant cardiac disease.
* History or presence of an ECG finding that, in the investigator's opinion, is clinically meaningful.
* Female participant is pregnant or breastfeeding within the projected duration of the study, starting with the screening visit through the 90-day safety follow-up, or male participant is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 100 days after the last dose of study treatment.
* Has received a live vaccine within 90 days of the planned start of study drug.
* Current use of a prohibited medication as described in protocol.
* Life expectancy \< 3 months.
* Known hypersensitivity or severe reaction to any component of study drug or formulation components.
* History of organ transplant, including allogeneic stem cell transplantation.
* Inability to swallow tablets or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 733 days
Secondary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: up to 733 days
measure: Duration of Response (DOR)
timeFrame: up to 733 days
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: up to 823 days
measure: Number of Participants With Any ≥Grade 3 TEAE
timeFrame: up to 823 days
Other outcomes:
Locations:
city: Burgas
country: Bulgaria
facility: Complex Oncology Center - Burgas Eood
city: Gabrovo
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" Jsc
city: Plovdiv
country: Bulgaria
facility: Complex Onclogy Center Plovdiv Eood
city: Varna
country: Bulgaria
facility: Shatod Dr. Marko - Varna Ltd
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Farkasgyepu
country: Hungary
facility: Complex Oncology Center - Burgas Eood
city: Kecskemet
country: Hungary
facility: Bacs Kiskun Megyei Oktatokorhaz
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent'S Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital Linkou
city: Dnipro
country: Ukraine
facility: Multifield Clinical Hospital No 4
city: Kharkiv
country: Ukraine
facility: Ci of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection
city: Kryvyi Rih
country: Ukraine
facility: Mi Kryviy Rih Center of Dnipropetrovsk Regional Council
city: Lutsk
country: Ukraine
facility: Volyn Regional Oncological Dispensary
city: Sumy
country: Ukraine
facility: Rmi Sumy Regional Clinical Oncology Dispensary
city: Uzhgorod
country: Ukraine
facility: Cne Ccch of Uzh Cc Oncological Center
city: Vyshhorod
country: Ukraine
facility: Medical Clinic Innovacia Llc
Study officials:
References: