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Non Small Cell Lung CancerPhase 2NCT04629339

Study of INCB086550 in Select Solid Tumors

A Phase 2 study testing INCB086550 in people with Non Small Cell Lung Cancer and Urothelial Cancer, run by Incyte Corporation at 20 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
INCB086550
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
20 sitesin 5 countries
Study dates
2 Sep 2021to 26 Mar 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 25Show fewer
  • 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.

Trial locations and contacts

20 sites in 5 countries.

20 sites in 5 countries

Ukraine7 sites

  • Multifield Clinical Hospital No 4

    Dnipro, 49102

  • Ci of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection

    Kharkiv, 61166

  • Mi Kryviy Rih Center of Dnipropetrovsk Regional Council

    Kryvyi Rih, 50048

  • Volyn Regional Oncological Dispensary

    Lutsk, 43018

  • Rmi Sumy Regional Clinical Oncology Dispensary

    Sumy, 40022

  • Cne Ccch of Uzh Cc Oncological Center

    Uzhhorod, 88000

  • Medical Clinic Innovacia Llc

    Vyshhorod, 07352

Other trials in Ukraine

South Korea5 sites

  • The Catholic University of Korea St. Vincent'S Hospital

    Gyeonggi-do, 16427

  • Korea University Anam Hospital

    Seoul, 02841

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

Bulgaria4 sites

  • Complex Oncology Center - Burgas Eood

    Burgas, 8000

  • Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" Jsc

    Gabrovo, 5300

  • Complex Onclogy Center Plovdiv Eood

    Plovdiv, 4004

  • Shatod Dr. Marko - Varna Ltd

    Varna, 9000

Other trials in Bulgaria

Hungary3 sites

  • Semmelweis Egyetem

    Budapest, 1085

  • Complex Oncology Center - Burgas Eood

    Farkasgyepű, 8582

  • Bacs Kiskun Megyei Oktatokorhaz

    Kecskemét, 6000

Other trials in Hungary

Taiwan1 site

  • Chang Gung Memorial Hospital Linkou

    Taoyuan City, 33305

Other trials in Taiwan

About this study

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

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

Being tested
INCB086550
Keywords
checkpoint inhibitor naive, Metastatic, PD-L1
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Hepatocellular, Melanoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INCB086550Drug

    INCB086550 will be administered orally twice a day.

Study groups in NCT04629339
Study groupRoleWhat they receive
INCB086550ExperimentalINCB086550 will be administered orally twice a day.
Receives: Drug: INCB086550

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), confirmed by ≥1 repeat assessment ≥28 days later, according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

    Measured: up to 733 days

Secondary outcomes (4)

  1. Disease Control Rate (DCR)

    DCR was defined as the percentage of participants with a best overall response of CR or PR, confirmed by ≥1 repeat assessment ≥28 days later, or stable disease (SD) for ≥12 weeks, by investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Progressive disease (PD): progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.

    Measured: up to 733 days

  2. Duration of Response (DOR)

    DOR was defined as the time from the earliest date of CR or PR, confirmed by ≥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. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.

    Measured: up to 733 days

  3. Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first.

    Measured: up to 823 days

  4. Number of Participants With Any ≥Grade 3 TEAE

    A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.

    Measured: up to 823 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2020
  2. Study start2 Sep 2021
  3. Primary completion26 Mar 2024
  4. Study completion26 Mar 2024

Why it stopped: Strategic business decision to terminate the study effective immediately. This is due to a company decision to prioritize another oral PD-L1 inhibitor with a more favorable profile.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04629339
Sponsor's protocol ID
INCB 86550-203
Status last verified
Feb 2025
First submitted
10 Nov 2020
Last updated
13 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INCB086550 in people with Non Small Cell Lung Cancer and Urothelial Cancer, run by Incyte Corporation at 20 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Ukraine, South Korea, Bulgaria, Hungary, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: up to 733 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04629339.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.

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Study of INCB086550 in Select Solid Tumors | AzTrials