Metastatic Cancer Clinical Trial
Official title:
A Phase 1/2 Safety and Efficacy Study of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
Verified date | June 2021 |
Source | Incyte Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies.
Status | Terminated |
Enrollment | 10 |
Est. completion date | July 1, 2020 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. - Phase 1: Subjects with advanced or metastatic solid tumors. - Phase 1: Subjects who have disease progression after treatment with available therapies. - Phase 2: Subjects with advanced or metastatic melanoma, RCC, and urothelial carcinoma. - Presence of measurable disease based on RECIST v1.1. - Eastern Cooperative Oncology Group performance status of 0 or 1. Exclusion Criteria: - Laboratory and medical history parameters not within the Protocol-defined range - Prior treatment with any tumor necrosis factor super family agonist. - Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug. - Has not recovered to = Grade 1 from toxic effects of prior therapy. - Active autoimmune disease. - Known active central nervous system metastases and/or carcinomatous meningitis. - Evidence of active, noninfectious pneumonitis or history of interstitial lung disease. - Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation. - Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies). |
Country | Name | City | State |
---|---|---|---|
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | The Angeles Clinic and Research Institute | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Incyte Biosciences International Sàrl |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment. | Screening through 60 days after end of treatment, up to approximately 18 months | |
Primary | Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST | Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1. | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months | |
Primary | Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1 | Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1 | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months | |
Secondary | Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST | Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1. | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months. | |
Secondary | Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST | Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause. | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months | |
Secondary | Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST | Defined as time from first report of SD or better until disease progression or death from any cause. | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months | |
Secondary | Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST | Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause. | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months | |
Secondary | Phase 1 & Phase 2: Overall Survival | Defined as the time from the start of combination therapy until death due to any cause. | At 1 year and 2 years. |
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