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Study of INCB086550 in Select Solid Tumors

Sponsor
Incyte Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04629339
Collaborator
(none)
16
Enrollment
12
Locations
1
Arm
33.3
Anticipated Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of INCB086550 (Oral PD-L1 Inhibitor) in Participants Who Are Immune Checkpoint Inhibitor-Naïve With Selected Solid Tumors
Actual Study Start Date :
Sep 2, 2021
Anticipated Primary Completion Date :
Sep 14, 2023
Anticipated Study Completion Date :
Jun 11, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: INCB086550

INCB086550 will be administered orally twice a day.

Drug: INCB086550
INCB086550 will be administered orally twice a day.

Outcome Measures

Primary Outcome Measures

  1. Objective Response Rate [up to 2 years]

    Defined as the percentage of participants with a best overall response of CR or PR confirmed by at least 1 repeat assessment ≥ 28 days later according to RECIST v1.1 as determined by the investigator.

Secondary Outcome Measures

  1. Disease Control Rate [up to 2 years]

    Defined as the percentage of participants with a best overall response of CR or PR confirmed by at least 1 repeat assessment ≥ 28 days later, or SD for ≥ 12 weeks, by investigator assessment per RECIST v1.1.

  2. Duration of Response [up to 2 years]

    Defined as the time from the earliest date of CR or PR confirmed by at least 1 repeat assessment ≥ 28 days later 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

  3. Safety and Tolerability of INCB86550 as Assessed by Number of Participants With a TEAE [up to 2 years]

    TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Complex Onclogy Center Plovdiv Eood Plovdiv Bulgaria 4004
2 Bacs Kiskun Megyei Oktatokorhaz Kecskemet Hungary 6000
3 Korea University Anam Hospital Seoul Korea, Republic of 02841
4 Severance Hospital Yonsei University Health System Seoul Korea, Republic of 03722
5 Chang Gung Memorial Hospital Linkou Taoyuan City Taiwan 33305
6 Multifield Clinical Hospital No 4 Dnipro Ukraine 49102
7 Ci of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection Kharkiv Ukraine 61166
8 Mi Kryviy Rih Center of Dnipropetrovsk Regional Council Kryvyi Rih Ukraine 50048
9 Volyn Regional Oncological Dispensary Lutsk Ukraine 43018
10 Rmi Sumy Regional Clinical Oncology Dispensary Sumy Ukraine 40022
11 Cne Ccch of Uzh Cc Oncological Center Uzhgorod Ukraine 88000
12 Medical Clinic Innovacia Llc Vyshhorod Ukraine 07352

Sponsors and Collaborators

  • Incyte Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT04629339
Other Study ID Numbers:
  • INCB 86550-203
First Posted:
Nov 16, 2020
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Incyte Corporation
checkpoint inhibitor naive
Metastatic
PD-L1
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell

Study Results

No Results Posted as of Mar 25, 2022