Study of INCB086550 in Select Solid Tumors
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| ClinicalTrials.gov Identifier: NCT04629339 |
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Recruitment Status :
Recruiting
First Posted : November 16, 2020
Last Update Posted : February 24, 2022
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Sponsor:
Incyte Corporation
Information provided by (Responsible Party):
Incyte Corporation
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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 |
|---|---|---|
| Non Small Cell Lung Cancer Urothelial Cancer Renal Cell Carcinoma Hepatocellular Carcinoma Melanoma | Drug: INCB086550 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 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 : | September 2, 2021 |
| Estimated Primary Completion Date : | September 14, 2023 |
| Estimated Study Completion Date : | June 11, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Melanoma
| Arm | Intervention/treatment |
|---|---|
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Experimental: INCB086550
INCB086550 will be administered orally twice a day.
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Drug: INCB086550
INCB086550 will be administered orally twice a day. |
Primary Outcome Measures :
- Objective Response Rate [ Time Frame: 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 :
- Disease Control Rate [ Time Frame: 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.
- Duration of Response [ Time Frame: 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
- Safety and Tolerability of INCB86550 as Assessed by Number of Participants With a TEAE [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04629339
Contacts
| Contact: Incyte Corporation Call Center (US) | 1.855.463.3463 | medinfo@incyte.com | |
| Contact: Incyte Corporation Call Center (ex-US) | +800 00027423 | eumedinfo@incyte.com |
Locations
Show 29 study locations
Sponsors and Collaborators
Incyte Corporation
| Responsible Party: | Incyte Corporation |
| ClinicalTrials.gov Identifier: | NCT04629339 |
| Other Study ID Numbers: |
INCB 86550-203 |
| First Posted: | November 16, 2020 Key Record Dates |
| Last Update Posted: | February 24, 2022 |
| Last Verified: | February 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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 |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications. |
| Access Criteria: | Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement. |
| URL: | https://www.incyte.com/our-company/compliance-and-transparency |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Incyte Corporation:
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checkpoint inhibitor naive Metastatic PD-L1 |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site |
Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases |