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Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies

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ClinicalTrials.gov Identifier: NCT03126110
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : December 10, 2018
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 INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.

Condition or disease Intervention/treatment Phase
Advanced Malignancies Metastatic Cancer Drug: INCAGN01876 Drug: Nivolumab Drug: Ipilimumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 285 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 INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
Actual Study Start Date : April 13, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: INCAGN01876 + Nivolumab
INCAGN01876 combined with nivolumab.
Drug: INCAGN01876
In Phase 1 subjects will receive INCAGN01876 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.

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

Experimental: INCAGN01876 + Ipilimumab
INCAGN01876 combined with ipilimumab.
Drug: INCAGN01876
In Phase 1 subjects will receive INCAGN01876 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.

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

Experimental: INCAGN01876 + Nivolumab + Ipilimumab
INCAGN01876 combined with nivolumab and ipilimumab.
Drug: INCAGN01876
In Phase 1 subjects will receive INCAGN01876 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.

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.




Primary Outcome Measures :
  1. 1. Phase 1: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs) [ Time Frame: Screening through 60 days after end of treatment, up to 18 months ]
    An AE is 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: Every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
    Defined as the percentage of subjects having complete response (CR) or partial response (PR)


Secondary Outcome Measures :
  1. Phase 1: ORR based on RECIST v1.1 and modified RECIST v1.1 (mRECIST 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 CR or PR

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

  4. Phase 1 & Phase 2: Progression-free survival based on RECIST v1.1 and mRECIST v1.1 [ 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.

  5. Phase 1 & Phase 2: Overall survival [ Time Frame: 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.

  6. Phase 2: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events [ Time Frame: Screening through 60 days after end of treatment, up to 18 months ]
    An AE is 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.



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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:

  • 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 cervical cancer, gastric cancer (including stomach, esophageal, and GEJ), SCCHN, PD-1 refractory SCCHN and PD-1/PD-L1 relapsed melanoma.
  • 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
  • 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).

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): NCT03126110


Contacts
Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

  Show 43 Study Locations
Sponsors and Collaborators
Incyte Biosciences International Sàrl
Investigators
Study Director: John E. Janik, MD Incyte Corporation

Responsible Party: Incyte Biosciences International Sàrl
ClinicalTrials.gov Identifier: NCT03126110     History of Changes
Other Study ID Numbers: INCAGN 1876-201
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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 ):
melanoma
cervical cancer
endometrial cancer
gastric cancer (stomach, esophageal, and gastroesophageal junction [GEJ])
hepatocellular carcinoma (HCC)
Merkel cell carcinoma
mesothelioma
microsatellite instability-high (MSI-H) colorectal cancer (CRC)
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)

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs