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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03126110




Registration number
NCT03126110
Ethics application status
Date submitted
19/04/2017
Date registered
24/04/2017

Titles & IDs
Public title
Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies
Scientific 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
Secondary ID [1] 0 0
INCAGN 1876-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Malignancies 0 0
Metastatic Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - INCAGN01876
Treatment: Drugs - Nivolumab
Treatment: Drugs - Ipilimumab

Experimental: Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W - Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.

Experimental: Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W - Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

Experimental: Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W - Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

Experimental: Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W - Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

Experimental: Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W - Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by INCAGN01876 1.0 mg/kg Q2W in combination with nivolumab 240 mg administered IV Q2W starting at Cycle 3.

Experimental: Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W - Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by INCAGN01876 1.0 mg/kg Q2W in combination with nivolumab 240 mg administered IV Q2W starting at Cycle 3.

Experimental: Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W - Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by INCAGN01876 5.0 mg/kg Q2W in combination with nivolumab 240 mg administered IV Q2W starting at Cycle 3.

Experimental: Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W - Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).

Experimental: Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W - Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

Experimental: Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W - Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

Experimental: Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab - Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.

Experimental: Phase 2 Group C2 PD-1/PD-L1: INCAGN01876 300 mg + ipilimumab 1 mg/kg - Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

Experimental: Phase 2 Group F GC: INCAGN01876 300 mg + nivolumab 240 mg - Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

Experimental: Phase 2 Group F SCCHN INCAGN01876 300 mg + nivolumab 240 mg - Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

Experimental: Phase 2 Group F CC: INCAGN01876 300 mg + nivolumab 240 mg - Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

Experimental: Phase 2 Group F PD-1/PD-L1: INCAGN01876 300 mg + nivolumab 240 mg - Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

Experimental: Phase 2 Group F Biopsy: INCAGN01876 300 mg + nivolumab 240 mg - Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.


Treatment: Drugs: INCAGN01876
In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().

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

Treatment: Drugs: Ipilimumab
Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Timepoint [1] 0 0
up to approximately 27.4 months
Primary outcome [2] 0 0
Phase 2: Objective Response Rate (ORR) Per RECIST v1.1
Timepoint [2] 0 0
up to approximately 44.7 months
Secondary outcome [1] 0 0
Phase 1: ORR Per RECIST v1.1
Timepoint [1] 0 0
up to approximately 44.7 months
Secondary outcome [2] 0 0
Phase 1: ORR Per Modified RECIST (mRECIST) v1.1
Timepoint [2] 0 0
up to approximately 44.7 months
Secondary outcome [3] 0 0
Phase 2: ORR Per mRECIST v1.1
Timepoint [3] 0 0
up to approximately 44.7 months
Secondary outcome [4] 0 0
Phase 1: Duration of Response (DOR) Per RECIST v1.1
Timepoint [4] 0 0
up to approximately 44.7 months
Secondary outcome [5] 0 0
Phase 2: DOR Per RECIST v1.1
Timepoint [5] 0 0
up to approximately 44.7 months
Secondary outcome [6] 0 0
Phase 1: DOR Per mRECIST v1.1
Timepoint [6] 0 0
up to approximately 44.7 months
Secondary outcome [7] 0 0
Phase 2: DOR Per mRECIST v1.1
Timepoint [7] 0 0
up to approximately 44.7 months
Secondary outcome [8] 0 0
Phase 1: Disease Control Rate (DCR) Per RECIST v1.1
Timepoint [8] 0 0
up to approximately 44.7 months
Secondary outcome [9] 0 0
Phase 2: DCR Per RECIST v1.1
Timepoint [9] 0 0
up to approximately 44.7 months
Secondary outcome [10] 0 0
Phase 1: DCR Per mRECIST v1.1
Timepoint [10] 0 0
up to approximately 44.7 months
Secondary outcome [11] 0 0
Phase 2: DCR Per mRECIST v1.1
Timepoint [11] 0 0
up to approximately 44.7 months
Secondary outcome [12] 0 0
Phase 1: Duration of Disease Control Per RECIST v1.1
Timepoint [12] 0 0
up to approximately 44.7 months
Secondary outcome [13] 0 0
Phase 2: Duration of Disease Control Per RECIST v1.1
Timepoint [13] 0 0
up to approximately 44.7 months
Secondary outcome [14] 0 0
Phase 1: Duration of Disease Control Per mRECIST v1.1
Timepoint [14] 0 0
up to approximately 44.7 months
Secondary outcome [15] 0 0
Phase 2: Duration of Disease Control Per mRECIST v1.1
Timepoint [15] 0 0
up to approximately 44.7 months
Secondary outcome [16] 0 0
Phase 1: Progression-free Survival (PFS) Per RECIST v1.1
Timepoint [16] 0 0
up to approximately 44.7 months
Secondary outcome [17] 0 0
Phase 2: PFS Per RECIST v1.1
Timepoint [17] 0 0
up to approximately 44.7 months
Secondary outcome [18] 0 0
Phase 1: PFS Per mRECIST v1.1
Timepoint [18] 0 0
up to approximately 44.7 months
Secondary outcome [19] 0 0
Phase 2: PFS Per mRECIST v1.1
Timepoint [19] 0 0
up to approximately 44.7 months
Secondary outcome [20] 0 0
Phase 1: Overall Survival
Timepoint [20] 0 0
up to approximately 44.7 months
Secondary outcome [21] 0 0
Phase 2: Overall Survival
Timepoint [21] 0 0
up to approximately 44.7 months
Secondary outcome [22] 0 0
Phase 2: : Number of Participants With Any TEAE
Timepoint [22] 0 0
up to approximately 27.4 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/11/2021
Sample size
Target
Accrual to date
Final
145
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Cancer and Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [3] 0 0
Greenslopes Private Hospital - Brisbane
Recruitment hospital [4] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [5] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2148 - Randwick
Recruitment postcode(s) [3] 0 0
4120 - Brisbane
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Belgium
State/province [14] 0 0
Chevigny
Country [15] 0 0
Belgium
State/province [15] 0 0
Antwerpen
Country [16] 0 0
Belgium
State/province [16] 0 0
Brussels
Country [17] 0 0
Belgium
State/province [17] 0 0
Bruxelles
Country [18] 0 0
Belgium
State/province [18] 0 0
Charleroi
Country [19] 0 0
Belgium
State/province [19] 0 0
Ghent
Country [20] 0 0
Belgium
State/province [20] 0 0
Kortrijk
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
Spain
State/province [22] 0 0
Córdoba
Country [23] 0 0
Spain
State/province [23] 0 0
Madrid
Country [24] 0 0
Spain
State/province [24] 0 0
Pamplona
Country [25] 0 0
Spain
State/province [25] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyte Biosciences International Sàrl
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John E. Janik, MD
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03126110