INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03277352
• Other study ID #: INCAGN 1876-202
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: November 21, 2017
• Est. completion date: July 1, 2020

Study information

• Verified date: June 2021
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Advanced Malignancies
• Metastatic Cancer
• Neoplasms

Intervention

Drug:
• INCAGN01876
In Phase 1 subjects will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose and schedule according to cohort and treatment group enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.
• Epacadostat
Epacadostat will be self-administered orally at the protocol-defined dose.
• Pembrolizumab
Pembrolizumab will be administered IV at the protocol-defined dose.

Locations

Country	Name	City	State
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	The Angeles Clinic and Research Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Biosciences International Sàrl

Country where clinical trial is conducted

United States, 

Outcome

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.