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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04128696




Registration number
NCT04128696
Ethics application status
Date submitted
15/10/2019
Date registered
16/10/2019
Date last updated
10/07/2024

Titles & IDs
Public title
Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Scientific title
A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Secondary ID [1] 0 0
2019-002263-99
Secondary ID [2] 0 0
209229
Universal Trial Number (UTN)
Trial acronym
INDUCE-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Head and Neck 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - feladilimab
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Placebo

Experimental: Participants receiving feladilimab and pembrolizumab - Participants were administered feladilimab (humanized anti-ICOS immunoglobulin G4 \[IgG4\] monoclonal antibody \[mAb\]) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an intravenous (IV) infusion once every three weeks.

Active comparator: Participants receiving placebo and pembrolizumab - Participants were administered placebo and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion once every three weeks.


Treatment: Drugs: feladilimab
feladilimab is available as an intravenous infusion.

Treatment: Drugs: Pembrolizumab
Pembrolizumab is available as an intravenous infusion.

Treatment: Drugs: Placebo
Placebo is available as an intravenous infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) in the Programmed Death Receptor-ligand 1 (PD-L1) Combined Positive Score (CPS) =1 Population
Timepoint [1] 0 0
Up to approximately 16 months
Primary outcome [2] 0 0
OS in the PD-L1 Expression High (CPS =20) Population
Timepoint [2] 0 0
Up to approximately 16 months
Primary outcome [3] 0 0
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) in the PD-L1 CPS =1 Population
Timepoint [3] 0 0
Up to approximately 16 months
Secondary outcome [1] 0 0
PFS Per Immune-based RECIST (iRECIST) in the PD-L1 CPS =1 Population
Timepoint [1] 0 0
Up to approximately 16 months
Secondary outcome [2] 0 0
PFS Per RECIST in the PD-L1 CPS =20 Population
Timepoint [2] 0 0
Up to approximately 16 months
Secondary outcome [3] 0 0
PFS Per iRECIST (iPFS) in the PD-L1 CPS =20 Population
Timepoint [3] 0 0
Up to approximately 16 months
Secondary outcome [4] 0 0
Milestone OS Rate at 12 Months in the PD-L1 CPS =1 Population
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Milestone OS Rate at 24 Months in the PD-L1 CPS =1 Population
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Milestone OS Rate at 12 Months in the PD-L1 CPS =20 Population
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Milestone OS Rate at 24 Months in the PD-L1 CPS =20 Population
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
Overall Response Rate (ORR) Per RECIST v1.1 in the PD-L1 CPS =1 Population
Timepoint [8] 0 0
Up to approximately 16 months
Secondary outcome [9] 0 0
ORR Per RECIST v1.1 in the PD-L1 CPS =20 Population
Timepoint [9] 0 0
Up to approximately 16 months
Secondary outcome [10] 0 0
Disease Control Rate (DCR) Per RECIST v1.1 in the PD-L1 CPS =1 Population
Timepoint [10] 0 0
Up to approximately 16 months
Secondary outcome [11] 0 0
DCR Per RECIST v1.1 in the PD-L1 CPS =20 Population
Timepoint [11] 0 0
Up to approximately 16 months
Secondary outcome [12] 0 0
Duration of Response (DoR) Per RECIST v1.1 in the PD-L1 CPS =1 Population
Timepoint [12] 0 0
Up to approximately 16 months
Secondary outcome [13] 0 0
DoR Per RECIST v1.1 in the PD-L1 CPS =20 Population
Timepoint [13] 0 0
Up to approximately 16 months
Secondary outcome [14] 0 0
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [14] 0 0
Up to approximately 43 months
Secondary outcome [15] 0 0
Number of Participants With AEs by Severity
Timepoint [15] 0 0
Up to approximately 43 months
Secondary outcome [16] 0 0
Number of Participants With SAEs by Severity
Timepoint [16] 0 0
Up to approximately 43 months
Secondary outcome [17] 0 0
Number of Participants With Adverse Events of Special Interest (AESI)
Timepoint [17] 0 0
Up to approximately 43 months
Secondary outcome [18] 0 0
Number of Participants With AESI by Severity
Timepoint [18] 0 0
Up to approximately 43 months
Secondary outcome [19] 0 0
Number of Participants With Dose Modifications
Timepoint [19] 0 0
Up to approximately 16 months
Secondary outcome [20] 0 0
Time to Deterioration (TTD) in Pain in the PD-L1 CPS =1 Population
Timepoint [20] 0 0
Up to approximately 16 months
Secondary outcome [21] 0 0
TTD in Pain in the PD-L1 CPS =20 Population
Timepoint [21] 0 0
Up to approximately 16 months
Secondary outcome [22] 0 0
TTD in Physical Function in the PD-L1 CPS =1 Population
Timepoint [22] 0 0
Up to approximately 16 months
Secondary outcome [23] 0 0
TTD in Physical Function in the PD-L1 CPS =20 Population
Timepoint [23] 0 0
Up to approximately 16 months

Eligibility
Key inclusion criteria
* Capable of giving signed informed consent
* Male or female, age >=18 years
* Histological or cytological documentation of Head and Neck Squamous Cell Carcinoma (HNSCC) that is considered incurable by local therapies
* Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx
* No prior systemic therapy administered in the recurrent or metastatic setting (except for systemic therapy given as part of multimodal treatment for locally advanced disease)
* Measurable disease per RECIST version 1.1 guidelines
* ECOG Performance PS score of 0 or 1
* Adequate organ function
* Life expectancy of at least 12 weeks
* Female participants: must not be pregnant, not breastfeeding, and at least one of the following conditions apply:

1. Not a woman of childbearing potential (WOCBP)
2. A WOCBP who agrees to use a method of birth control from 30 days prior to randomization and for at least 120 days after the last dose of study treatment
* Male participants with female partners of child-bearing potential: must agree to use a highly effective contraception while receiving study treatment and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period
* Provide tumor tissue from excisional or core biopsy (fine needle aspirates and bone biopsies are not acceptable) acquired within 2 years prior to randomization for PD-L1 immunohistochemistry (IHC) testing by central laboratory
* Have PD-L1 Immunohistochemistry (IHC) CPS 1 status by central laboratory testing
* Have results from testing of Human Papilloma Virus (HPV) status for oropharyngeal cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior therapy with an anti-PD-1/L1/L2 and/or anti-ICOS directed agent
* Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter
* Major surgery 28 days prior to randomization
* Has high risk of bleeding
* Toxicity related to prior treatment that has not resolved to <=Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be<= Grade 2)
* Received transfusion of blood products or administration of colony stimulating factors within 14 days prior to randomization
* Central nervous system (CNS) metastases, with the following exception: Participants with asymptomatic CNS metastases who are clinically stable and have no requirement for steroids for at least 14 days prior to randomization
* Invasive malignancy or history of invasive malignancy other than disease under study within the last 3 years, except as noted below:

a. Any other invasive malignancy for which the participant was definitively treated, has been disease-free for 3 years and in the opinion of the principal investigator and GSK Medical Monitor will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy, may be included in this clinical study
* Autoimmune disease or syndrome that required systemic treatment within the past 2 years
* Has a diagnosis of immunodeficiency or is receiving systemic steroids (=10 mg oral prednisone per day or equivalent) or other immunosuppressive agents within 7 days prior to randomization
* Receipt of any live vaccine within 30 days prior randomization
* Prior allogeneic/autologous bone marrow or solid organ transplantation
* Has current pneumonitis or history of non-infectious pneumonitis that required steroids or other immunosuppressive agents
* Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions
* Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess
* Recent history of allergen desensitization therapy within 4 weeks of randomization
* History or evidence of cardiac abnormalities within the 6 months prior to randomization
* Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice
* Active infection requiring systemic therapy
* Known HIV infection, or positive test for hepatitis B active infection (presence of hepatitis B surface antigen), or hepatitis C active infection
* History of severe hypersensitivity to monoclonal antibodies or any ingredient used in the study treatment formulations
* Known history of active tuberculosis
* Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator
* Is currently participating in (unless in follow-up phase and 4 weeks have elapsed from last dose of prior investigational agent), or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to date of randomization
* Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/06/2023
Sample size
Target
Accrual to date
Final
315
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Blacktown
Recruitment hospital [2] 0 0
GSK Investigational Site - St Leonards
Recruitment hospital [3] 0 0
GSK Investigational Site - Herston
Recruitment hospital [4] 0 0
GSK Investigational Site - Heidelberg
Recruitment hospital [5] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [6] 0 0
GSK Investigational Site - Nedlands
Recruitment hospital [7] 0 0
GSK Investigational Site - Darlinghurst
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma de Buenos Aires
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Argentina
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San Juan
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Brazil
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Espírito Santo
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Brazil
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Santa Catarina
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São Paulo
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Brazil
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Belo Horizonte, Minas Gerais
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Alberta
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Canada
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British Columbia
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Ontario
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Guangdong
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Bengbu
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Harbin
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Hefei
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Shnghai
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Copenhagen
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Bordeaux
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Epagny Metz-Tessy
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Lille
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Saint Herblain cedex
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Toulouse Cedex 9
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Valenciennes Cedex
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Baden-Wuerttemberg
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Nordrhein-Westfalen
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Sachsen
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Hamburg
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Heraklion,Crete
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Jerusalem
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Petah Tikva
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Ramat Gan
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Emilia-Romagna
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Lombardia
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Piemonte
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Veneto
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Chiba
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Ehime
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Fukuoka
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Hokkaido
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Hyogo
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Ibaraki
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Iwate
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Kagawa
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Kanagawa
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Miyagi
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Niigata
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Osaka
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Saitama
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Japan
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Shizuoka
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Tokyo
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Korea, Republic of
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Busan
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Korea, Republic of
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Hwasun,Jeollanam-do
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam-si, Gyeonggi-do
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Korea, Republic of
State/province [77] 0 0
Seoul,
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Korea, Republic of
State/province [78] 0 0
Seoul
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Mexico
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Coahuila
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Mexico
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Jalisco
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Netherlands
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Maastricht
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Rotterdam
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Norway
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Bergen
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Norway
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Oslo
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Poland
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Bydgoszcz
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Poland
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Gdynia
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Gliwice
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Krakow
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Olsztyn
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Tomaszow Mazowiecki
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Poland
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Warszawa
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Matosinhos
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Portugal
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Porto
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Romania
State/province [96] 0 0
Brasov
Country [97] 0 0
Romania
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Bucuresti
Country [98] 0 0
Romania
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Cluj Napoca
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Romania
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Cluj-Napoca
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Romania
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Constanta
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Romania
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Craiova
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Romania
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Floresti
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Romania
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Iasi
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Romania
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Oradea
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Romania
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Otopeni
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Romania
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Satu Mare
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Romania
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Suceava
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Russian Federation
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Moscow
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Russian Federation
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Poselok Kuzmolovsky
Country [110] 0 0
Russian Federation
State/province [110] 0 0
Pushkin
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Saint-Petersburg
Country [112] 0 0
Russian Federation
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St. Petersburg
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Russian Federation
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Yaroslavl
Country [114] 0 0
Spain
State/province [114] 0 0
Barcelona
Country [115] 0 0
Spain
State/province [115] 0 0
Madrid
Country [116] 0 0
Spain
State/province [116] 0 0
Málaga
Country [117] 0 0
Spain
State/province [117] 0 0
Pozuelo De Alarcón/Madrid
Country [118] 0 0
Spain
State/province [118] 0 0
Santiago de Compostela
Country [119] 0 0
Spain
State/province [119] 0 0
Valencia
Country [120] 0 0
Spain
State/province [120] 0 0
Zaragoza
Country [121] 0 0
Switzerland
State/province [121] 0 0
St Gallen
Country [122] 0 0
Switzerland
State/province [122] 0 0
Zuerich
Country [123] 0 0
Taiwan
State/province [123] 0 0
Changhua
Country [124] 0 0
Taiwan
State/province [124] 0 0
Kaohsiung City
Country [125] 0 0
Taiwan
State/province [125] 0 0
Taipei
Country [126] 0 0
Taiwan
State/province [126] 0 0
Taoyuan City
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Lancashire
Country [128] 0 0
United Kingdom
State/province [128] 0 0
London
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Nottingham
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC).This is a randomized, double-blind, adaptive Phase II/III study comparing a combination of GSK3359609 inducible T cell co-stimulatory receptor (ICOS) agonist and pembrolizumab to pembrolizumab plus placebo in participants with programmed death receptor 1-ligand 1 (PD-L1) combined positive score (CPS) \>=1 R/M HNSCC.
Trial website
https://clinicaltrials.gov/study/NCT04128696
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04128696