Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03241173
Recruitment Status : Active, not recruiting
First Posted : August 7, 2017
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation ( Incyte Biosciences International Sàrl )

Brief Summary:
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01949 when given in combination with immune therapies in participants with advanced or metastatic malignancies.

Condition or disease Intervention/treatment Phase
Advanced Malignancies Drug: INCAGN01949 Drug: Nivolumab Drug: Ipilimumab Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01949 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019


Arm Intervention/treatment
Experimental: INCAGN01949 + Nivolumab
INCAGN01949 combined with nivolumab.
Drug: Nivolumab
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.

Drug: INCAGN01949
In Phase 1 subjects will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.

Experimental: INCAGN01949 + Ipilimumab
INCAGN01949 combined with ipilimumab.
Drug: INCAGN01949
In Phase 1 subjects will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment.

Drug: Ipilimumab
Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.

Experimental: INCAGN01949 + Nivolumab + Ipilimumab
INCAGN01949 combined with nivolumab and ipilimumab.
Drug: Nivolumab
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.

Drug: Ipilimumab
Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.

Drug: INCAGN01949
In Phase 1 subjects will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.




Primary Outcome Measures :
  1. Phase 1: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] [ Time Frame: Screening through 60 days after end of treatment, up to 18 months ]
    TEAEs defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.

  2. Phase 2: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
    Defined as the percentage of subjects having a complete response (CR) or partial response (PR).


Secondary Outcome Measures :
  1. Phase 1 & Phase 2: ORR based on RECIST v1.1 and modified RECIST (mRECIST) [ Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
    Defined as the percentage of subjects having a CR or PR.

  2. Phase 1 & Phase 2: Duration of response based on RECIST v1.1 and mRECIST [ Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
    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, if occurring sooner than progression.

  3. Phase 1 & Phase 2: Disease control rate based on RECIST v1.1 and mRECIST [ Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
    Defined as the percentage of subjects having a CR, PR, or stable disease (SD).

  4. Phase 1 & Phase 2: Duration of disease control based on RECIST v1.1 and mRECIST [ Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
    Defined as CR, PR, and SD as measured from first report of SD or better until disease progression or death from any cause, if occurring sooner than progression.

  5. Phase 1 & Phase 2: Progression-free survival based on RECIST v1.1 and mRECIST [ Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
    Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause, if occurring sooner than progression.

  6. Phase 1 & Phase 2: Overall survival [ Time Frame: At 1 year, 2 years, and end of study, up to 24 months ]
    Determined from the start of combination therapy until death due to any cause.

  7. Phase 1 & Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] [ Time Frame: Screening through 60 days after end of treatment, up to 18 months ]
    TEAEs defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 gastric cancer, SCCHN, NSCLC, or RCC and are considered refractory to prior PD-1/L1 therapy.
  • Presence of measurable disease based on RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

Exclusion Criteria:

  • Laboratory and medical history parameters not within the Protocol-defined range
  • 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.

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): NCT03241173


Locations
Layout table for location information
United States, Alabama
The University of Alabama Birmingham (UAB)
Birmingham, Alabama, United States, 90025
United States, Arizona
Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale, Arizona, United States, 85258
United States, California
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
United States, Florida
Mount Sinai Medical Center of Florida, Inc.
Miami, Florida, United States, 33140
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New Jersey
John Theurer Cancer Center At Hackensack UMC
Hackensack, New Jersey, United States, 07601
Rutgers, The State University
New Brunswick, New Jersey, United States, 08901
United States, New York
New York University Clinical Cancer Center
New York, New York, United States, 10016
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Sarah Cannon Research Institute, LLC (SCRI)
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Incyte Biosciences International Sàrl
Investigators
Layout table for investigator information
Study Director: John E. Janik, MD Incyte Corporation

Layout table for additonal information
Responsible Party: Incyte Biosciences International Sàrl
ClinicalTrials.gov Identifier: NCT03241173     History of Changes
Other Study ID Numbers: INCAGN 1949-201
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation ( Incyte Biosciences International Sàrl ):
advanced or metastatic cervical cancer
endometrial cancer
esophageal cancer
hepatocellular carcinoma (HCC)
melanoma
Merkel cell carcinoma
mesothelioma
microsatellite instability-high colorectal cancer
non-small cell lung cancer (NSCLC)
ovarian cancer
squamous cell carcinoma of the head and neck
small cell lung cancer (SLCL)
renal cell carcinoma (RCC)
triple-negative breast cancer
TNBC
urothelial carcinoma
OX40 ligand (OX40)
SCCHN
MSI-H CRC
gastric cancer (including stomach and gastroesophageal junction [GEJ])

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents