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

NCT03277352 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: INCAGN 1876-202
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Advanced Malignancies; Metastatic Cancer

Keywords

cervical cancer; endometrial cancer; gastric cancer (including stomach and gastroesophageal junction (GEJ)); esophageal cancer; hepatocellular carcinoma (HCC); melanoma (mucosal or cutaneous); Merkel cell carcinoma; mesothelioma; microsatellite instability-high (MSI-H); solid tumors; non-small cell lung cancer (NSCLC); ovarian cancer; squamous cell carcinoma of the head and neck (SCCHN); small cell lung cancer (SCLC); renal cell carcinoma (RCC); triple-negative breast cancer (TNBC); urothelial carcinoma; glucocorticoid-induced tumor necrosis factor receptor (GITR)

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST

  Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months.

• Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST

  Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months

• Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST

  Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months

• Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST

  Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months

• Phase 1 & Phase 2: Overall Survival

  At 1 year and 2 years.

Study Arms (1)

INCAGN01876 + Pembrolizumab + Epacadostat

EXPERIMENTAL

INCAGN01876 in combination with pembrolizumab and epacadostat

Drug: INCAGN01876; Drug: Epacadostat; Drug: Pembrolizumab

Interventions

INCAGN01876 DRUG

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.

INCAGN01876 + Pembrolizumab + Epacadostat

Epacadostat DRUG

Epacadostat will be self-administered orally at the protocol-defined dose.

Also known as: INCB024360

INCAGN01876 + Pembrolizumab + Epacadostat

Pembrolizumab DRUG

Pembrolizumab will be administered IV at the protocol-defined dose.

Also known as: Keytruda®

INCAGN01876 + Pembrolizumab + Epacadostat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Incyte Biosciences International Sàrl: lead

Study Sites (2)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Uterine Cervical Neoplasms; Endometrial Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Carcinoma, Hepatocellular; Melanoma; Carcinoma, Merkel Cell; Mesothelioma; Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms; Squamous Cell Carcinoma of Head and Neck; Small Cell Lung Carcinoma; Carcinoma, Renal Cell; Triple Negative Breast Neoplasms; Carcinoma, Transitional Cell

Interventions

epacadostat; pembrolizumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Liver Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Adenoma; Neoplasms, Mesothelial; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma, Squamous Cell; Kidney Neoplasms; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Breast Neoplasms; Breast Diseases

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• John N. Janik, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: September 11, 2017
• Study Start: November 21, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 22, 2021
• Results First Posted: July 22, 2021

Record last verified: 2021-06

Locations

US (2)