A Phase 2 Study of INCB086550 (Oral PD-L1 Inhibitor) in Participants Who Are Immune Checkpoint Inhibitor–Naïve With Selected Solid Tumors

Phase 1

Conditions: Immune Checkpoint Inhibitor–Naïve Selected Solid Tumors
MedDRA version: 21.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 100000004864
MedDRA version: 21.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2020-000157-27-BG

Lead Sponsor: Incyte Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 304

Inclusion Criteria

1. Ability to comprehend and willingness to sign a written ICF for the study.
2. Men and women 18 years of age or older.
3. Measurable disease per RECIST v1.1.
4. ECOG performance status of 0 to 1 for all tumor types. Urothelial carcinoma allows ECOG of 0 to 2.
5. Histologically or cytologically confirmed disease-specific diagnosis as follows:
a. Treatment-naïve, stage IV NSCLC (AJCC v8) in participants whose tumors express PD-L1 TPS = 50% using the Dako PD-L1 IHC 22C3 assay and who have no known activating genomic aberrations that require targeted therapy (eg, EGFR, ALK, ROS, BRAF).
b. Locally advanced, and unresectable or metastatic UC of the renal pelvis, ureter, bladder, or urethra (including transitional cell and mixed transitional or nontransitional cell histologies) in participants who are cisplatin-ineligible, who are immune checkpoint inhibitor–naïve, and whose tumors express high PD-L1 (CPS = 10) using the Dako PD-L1 IHC 22C3 assay.
c. Advanced HCC that is not amenable to curative surgery or local treatment in participants who have received at least 1 previous line of systemic therapy (ie, sorafenib or lenvatinib) or who were intolerant of sorafenib/lenvatinib treatment, have a Child-Pugh score of = 6 (Child-Pugh A), and who are immune checkpoint inhibitor–naïve. Exception for HCC: Participants without access to prior systemic therapy (ie, sorafenib or lenvatinib).
d. Advanced or metastatic RCC with a clear cell component with or without sarcomatoid features in participants who have received prior systemic therapy for their disease (up to 2 previous regimens of a VEGF or mTOR inhibitor) and who are immune checkpoint inhibitor–naïve.
Exception for RCC: Participants without access to prior systemic therapy (ie, VEGF or mTOR inhibitors).
e. Unresectable stage III or IV melanoma (excluding ocular/uveal melanoma) in participants who are immune checkpoint inhibitor–naïve. BRAF V600 mutation status must be known.
Exception for melanoma: Participants may have received 1 prior line of
therapy. This therapy could include previous
treatment with BRAF/MEK inhibitors in participants with known BRAF V600 mutation or chemotherapy.
6. Willingness to avoid pregnancy or fathering children (CTFG 2020).
7. Participants must have radiologic documentation of disease
progression after treatment with available therapies except for
participants with NSCLC, who are required to be treatment-naïve.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 152
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 152

Exclusion Criteria

1. 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).
2. Receipt of any anticancer therapy or participation in another interventional clinical study.
3. Radiotherapy within 14 days of first dose of study treatment (28 days for pelvic radiotherapy or 6 months for thoracic region radiotherapy that is > 30 Gy).
4. Concomitant treatment with moderate and potent CYP3A4/CYP3A5 inhibitors or inducers
5. 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).
6. Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
7. Participants with laboratory values at screening as defined in the protocol.
8. Active malignancy of a type not included in the study population requiring treatment.
9. Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent).
10. Evidence of interstitial lung disease or active, noninfectious pneumonitis.
11. Untreated or known active CNS metastases and/or carcinomatous meningitis.
12. 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). Note: For participants with cleared prior HBV infection: HBV prophylaxis
should be considered per investigator discretion. Monitor for HBV
reactivation every 3 cycles by performing HBV viral load and HBsAg
serology test. Additional viral serologic testing may be performed at the
investigator's discretion.
13. Active infection requiring systemic therapy.
14. Receipt of systemic antibiotics within 28 days of first dose of study treatment.
15. Probiotic usage during screening and throughout the study treatment period.
16. Participants who are known to be HIV-positive.
17. Participants with impaired cardiac function or clinically significant cardiac disease:
a. New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant ventricular arrhythmia, congestive heart failure, or cardiomyopathy.
b. Unstable angina pectoris = 6 months before study participation.
c. Acute myocardial infarction = 6 months before study participation.
d. Other clinically significant heart disease (ie, = Grade 3 hypertension, history of labile hypertension, or poor compliance with an antihypertensive regimen) must have recovered (to baseline or = Grade 1) from toxicity associated with prior treatment.
18. History or presence of an ECG finding that, in the investigator's opinion, is clinically meaningful. sponsor approval.
19. 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.
20. Has received a live vaccine within 90 days of the planned start of study drug.
21. Current use of a prohibited medication as described in the protocol.
22. Life expectancy < 3 months.
23. Known

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials