ANZCTR - Registration

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02723955

Additional trial details provided through ANZCTR are available at the end of this record.

Registration number

NCT02723955

Ethics application status

Date submitted

24/03/2016

Date registered

31/03/2016

Titles & IDs

Public title

Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)

Scientific title

A Phase I Open Label Study of GSK3359609 Administered Alone and in Combination With Anticancer Agents in Subjects With Selected Advanced Solid Tumors

Secondary ID [1]

2016-000148-32

Secondary ID [2]

204691

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Neoplasms

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Experimental: Part 1A: Dose escalation feladilimab (GSK3359609) - Participants will receive feladilimab (GSK3359609) administered continuously at a dose level dependent on to which dose level the participant is accrued.

Experimental: Part 1B: Expansion feladilimab (GSK3359609) - Participants will receive feladilimab (GSK3359609) administered continuously at a dose level chosen for further exploration in dose expansion cohorts.

Experimental: Part 2A: Dose escalation (feladilimab (GSK3359609)+pembrolizumab) - Participants will receive feladilimab (GSK3359609) administered continuously in combination with pembrolizumab.

Experimental: Part 2A: Dose escalation (feladilimab (GSK3359609)+GSK3174998) - Participants will receive feladilimab (GSK3359609) administered continuously in combination with GSK3174998.

Experimental: Part 2A: Safety run-in (feladilimab (GSK3359609)+chemotherapy) - Participants participating in Part 2A chemotherapy combination cohorts will receive feladilimab (GSK3359609) in combination with chemotherapy at doses and schedules based on standard of care practice.

Experimental: Part 2B: Expansion-feladilimab (GSK3359609) - Participants will receive feladilimab (GSK3359609) administered continuously in combination with pembrolizumab.

Experimental: Part 2A: Dose escalation (feladilimab (GSK3359609)+ dostarlimab) - Participants will receive feladilimab (GSK3359609) administered continuously in combination with dostarlimab.

Experimental: Part 2A: Dose escalation (feladilimab (GSK3359609)+dostarlimab+cobolimab) - Participants will receive feladilimab (GSK3359609) administered continuously in combination with dostarlimab followed by cobolimab.

Experimental: Part 2A: Dose escalation (feladilimab (GSK3359609)+bintrafusp alfa) - Participants will receive feladilimab (GSK3359609) administered continuously in combination with bintrafusp alfa.

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)

Timepoint [1]

Up to approximately 367 weeks

Primary outcome [2]

Part 1A: Number of Participants With Dose Limiting Toxicity (DLT)

Timepoint [2]

Up to 28 days

Primary outcome [3]

Part 1A: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters

Timepoint [3]

Baseline (Day 1) and up to approximately 367 weeks

Primary outcome [4]

Part 1A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline

Timepoint [4]

Up to approximately 367 weeks

Primary outcome [5]

Part 1A: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters

Timepoint [5]

Baseline (Day 1) and up to approximately 367 weeks

Primary outcome [6]

Part 1A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline

Timepoint [6]

Up to approximately 367 weeks

Primary outcome [7]

Part 1A: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline

Timepoint [7]

Up to approximately 367 weeks

Primary outcome [8]

Part 1A: Number of Participants With Dose Modifications of Feladilimab

Timepoint [8]

Up to approximately 367 weeks

Primary outcome [9]

Part 2A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)

Timepoint [9]

Up to approximately 367 weeks

Primary outcome [10]

Part 2A: Number of Participants With Dose Limiting Toxicity (DLT)

Timepoint [10]

Up to 28 days

Primary outcome [11]

Part 2A: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters

Timepoint [11]

Baseline (Day 1) and up to approximately 367 weeks

Primary outcome [12]

Part 2A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline

Timepoint [12]

Up to approximately 367 weeks

Primary outcome [13]

Part 2A: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters

Timepoint [13]

Baseline (Day 1) and up to approximately 367 weeks

Primary outcome [14]

Part 2A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline

Timepoint [14]

Up to approximately 367 weeks

Primary outcome [15]

Part 2A: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline

Timepoint [15]

Up to approximately 367 weeks

Primary outcome [16]

Part 2A: Number of Participants With Dose Modifications of Feladilimab

Timepoint [16]

Up to approximately 367 weeks

Secondary outcome [1]

Part 1B: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)

Timepoint [1]

Up to approximately 367 weeks

Secondary outcome [2]

Part 1B: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters

Timepoint [2]

Baseline (Day 1) and up to approximately 367 weeks

Secondary outcome [3]

Part 1B: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline

Timepoint [3]

Up to approximately 367 weeks

Secondary outcome [4]

Part 1B: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters

Timepoint [4]

Baseline (Day 1) and up to approximately 367 weeks

Secondary outcome [5]

Part 1B: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline

Timepoint [5]

Up to approximately 367 weeks

Secondary outcome [6]

Part 1B: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline

Timepoint [6]

Up to approximately 367 weeks

Secondary outcome [7]

Part 1B: Number of Participants With Dose Modifications of Feladilimab

Timepoint [7]

Up to approximately 367 weeks

Secondary outcome [8]

Part 2B: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)

Timepoint [8]

Up to approximately 367 weeks

Secondary outcome [9]

Part 2B: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters

Timepoint [9]

Baseline (Day 1) and up to approximately 367 weeks

Secondary outcome [10]

Part 2B: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline

Timepoint [10]

Up to approximately 367 weeks

Secondary outcome [11]

Part 2B: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters

Timepoint [11]

Baseline (Day 1) and up to approximately 367 weeks

Secondary outcome [12]

Part 2B: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline

Timepoint [12]

Up to approximately 367 weeks

Secondary outcome [13]

Part 2B: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline

Timepoint [13]

Up to approximately 367 weeks

Secondary outcome [14]

Part 2B: Number of Participants With Dose Modifications of Feladilimab

Timepoint [14]

Up to approximately 367 weeks

Secondary outcome [15]

Part 1A: Overall Response Rate (ORR)

Timepoint [15]

Up to approximately 367 weeks

Secondary outcome [16]

Part 1A: Disease Control Rate (DCR)

Timepoint [16]

Up to approximately 367 weeks

Secondary outcome [17]

Part 1A: Overall Survival (OS)

Timepoint [17]

Up to approximately 367 weeks

Secondary outcome [18]

Part 1A: Progression-free Survival (PFS)

Timepoint [18]

Up to approximately 367 weeks

Secondary outcome [19]

Part 1A: Time to Overall Response (TTR)

Timepoint [19]

Up to approximately 367 weeks

Secondary outcome [20]

Part 1A: Duration of Response (DOR)

Timepoint [20]

Up to approximately 367 weeks

Secondary outcome [21]

Part 2A: Overall Response Rate (ORR)

Timepoint [21]

Up to approximately 367 weeks

Secondary outcome [22]

Part 2A: Disease Control Rate (DCR)

Timepoint [22]

Up to approximately 367 weeks

Secondary outcome [23]

Part 2A: Overall Survival (OS)

Timepoint [23]

Up to approximately 367 weeks

Secondary outcome [24]

Part 2A: Progression-free Survival (PFS)

Timepoint [24]

Up to approximately 367 weeks

Secondary outcome [25]

Part 2A: Time to Overall Response (TTR)

Timepoint [25]

Up to approximately 367 weeks

Secondary outcome [26]

Part 2A: Duration of Response (DOR)

Timepoint [26]

Up to approximately 367 weeks

Secondary outcome [27]

Part 1B: Overall Response Rate (ORR)

Timepoint [27]

Up to approximately 367 weeks

Secondary outcome [28]

Part 1B: Disease Control Rate (DCR)

Timepoint [28]

Up to approximately 367 weeks

Secondary outcome [29]

Part 1B: Overall Survival (OS)

Timepoint [29]

Up to approximately 367 weeks

Secondary outcome [30]

Part 1B: Progression-free Survival (PFS)

Timepoint [30]

Up to approximately 367 weeks

Secondary outcome [31]

Part 1B: Time to Overall Response (TTR)

Timepoint [31]

Up to approximately 367 weeks

Secondary outcome [32]

Part 1B: Duration of Response (DOR)

Timepoint [32]

Up to approximately 367 weeks

Secondary outcome [33]

Part 2B: Overall Response Rate (ORR)

Timepoint [33]

Up to approximately 367 weeks

Secondary outcome [34]

Part 2B: Disease Control Rate (DCR)

Timepoint [34]

Up to approximately 367 weeks

Secondary outcome [35]

Part 2B: Overall Survival (OS)

Timepoint [35]

Up to approximately 367 weeks

Secondary outcome [36]

Part 2B: Progression-free Survival (PFS)

Timepoint [36]

Up to approximately 367 weeks

Secondary outcome [37]

Part 2B: Time to Overall Response (TTR)

Timepoint [37]

Up to approximately 367 weeks

Secondary outcome [38]

Part 2B: Duration of Response (DOR)

Timepoint [38]

Up to approximately 367 weeks

Secondary outcome [39]

Part 1A: Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Ctau) of Feladilimab

Timepoint [39]

Pre-dose; end of infusion (EOI); 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours POST EOI; week 1; week 2; Pre-dose and 0.5 hours POST EOI in week 3; week 4; week 5; Pre-dose and 0.5 hours POST EOI in week 6, 9, 12 15; Pre-dose in week 21 and 33

Secondary outcome [40]

Part 1A: Area Under the Concentration-time Curve From Time 0 to 504 Hours After Dosing [AUC (0-504h)] of Feladilimab

Timepoint [40]

Pre-dose; end of infusion (EOI); 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5 hours post-EOI in week 6, 9, 12 15; Pre-dose in week 21 and 33

Secondary outcome [41]

Part 2A: Ctau of Pembrolizumab

Timepoint [41]

Pre-dose and 24 hours post-EOI on day 1; week 1; week 2; Pre-dose in week 3; week 4; week 5; Pre-dose in week 9, 15, 18, 21, 33, 45, 57, 69, 81 and 93

Secondary outcome [42]

Part 2A: AUC (0-504h) of Pembrolizumab

Timepoint [42]

Pre-dose and 24 hours post-EOI on day 1; week 1; week 2; Pre-dose in week 3; week 4; week 5; Pre-dose in week 9, 15, 18, 21, 33, 45, 57, 69, 81 and 93

Secondary outcome [43]

Part 2A: Cmax and Ctau of GSK3174998

Timepoint [43]

Pre-dose and 24 hours post-EOI on day 1; week 1; week 2; Pre-dose in week 3; week 4; week 5; Pre-dose in week 9, 15, 18, 21, 33, 45, 57, 69, 81 and 93

Secondary outcome [44]

Part 2A: AUC (0-504 h) of GSK3174998

Timepoint [44]

Pre-dose and 24 hours post-EOI on day 1; week 1; week 2; Pre-dose in week 3; week 4; week 5; Pre-dose in week 9, 15, 18, 21, 33, 45, 57, 69, 81 and 93

Secondary outcome [45]

Part 1B: Cmax and Ctau of Feladilimab

Timepoint [45]

Secondary outcome [46]

Part 1B: AUC (0-504 h) of Feladilimab

Timepoint [46]

Secondary outcome [47]

Part 2B: Cmax and Ctau of Feladilimab

Timepoint [47]

Pre-dose; EOI; 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5, 4 hours post-EOI in week 6, 9, 12 and15; Pre-dose in week 18, 21, 33, 45, 57, 69, 81 and 93

Secondary outcome [48]

Part 2B: AUC (0-504 h) of Feladilimab

Timepoint [48]

Secondary outcome [49]

Part 2B: AUC (0-1008 h) of Feladilimab

Timepoint [49]

Secondary outcome [50]

Part 2B: Cmax and Ctau of Pembrolizumab

Timepoint [50]

Secondary outcome [51]

Part 2B: AUC (0-504h) of Pembrolizumab

Timepoint [51]

Secondary outcome [52]

Part 1A: Number of Participants With Positive Results in Anti-drug Antibody (ADA) Test by Feladilimab Dose Level

Timepoint [52]

Up to approximately 367 weeks

Secondary outcome [53]

Part 2A: Number of Participants With Positive Results in ADA Test by Feladilimab in Combination With GSK3174998 Dose Level

Timepoint [53]

Up to approximately 367 weeks

Secondary outcome [54]

Part 2A: Number of Participants With Positive Results in ADA Test by Feladilimab Dose Level in Combination With Pembrolizumab

Timepoint [54]

Up to approximately 367 weeks

Secondary outcome [55]

Part 2A: Number of Participants With Positive Results in ADA in Pembrolizumab

Timepoint [55]

Up to approximately 367 weeks

Secondary outcome [56]

Part 2A: Number of Participants With Positive Results in ADA in GSK3174998

Timepoint [56]

Up to approximately 367 weeks

Secondary outcome [57]

Part 2A: Number of Participants With Positive Results in ADA Test by Feladilimab Combination With Chemotherapies Dose Level

Timepoint [57]

Up to approximately 367 weeks

Secondary outcome [58]

Part 1B: Number of Participants With Positive Results in ADA Test by Feladilimab Dose Level

Timepoint [58]

Up to approximately 367 weeks

Secondary outcome [59]

Part 2B: Number of Participants With Positive Results in ADA Test by Feladilimab Dose Level

Timepoint [59]

Up to approximately 367 weeks

Secondary outcome [60]

Part 2B: Number of Participants With Positive Results in ADA in Pembrolizumab

Timepoint [60]

Up to approximately 367 weeks

Secondary outcome [61]

Part 1A: Receptor Occupancy of Feladilimab

Timepoint [61]

Up to approximately 367 weeks

Secondary outcome [62]

Part 2A: Receptor Occupancy of Feladilimab

Timepoint [62]

Up to approximately 367 weeks

Secondary outcome [63]

Part 1B: Receptor Occupancy of Feladilimab

Timepoint [63]

Up to approximately 367 weeks

Secondary outcome [64]

Part 2B: Receptor Occupancy of Feladilimab

Timepoint [64]

Up to approximately 367 weeks

Eligibility

Key inclusion criteria

Inclusion Criteria

* Capable of giving signed, written informed consent.
* Male or female, age 18 to 93 years (at the time consent is obtained).
* Histological or cytological documentation of an invasive malignancy that was diagnosed as locally advanced/metastatic or relapsed/refractory and is of one of the following tumor types: bladder/urothelial cancer of the upper and lower urinary tract; cervical; colorectal (includes appendix); esophagus, squamous cell; head and neck carcinoma; melanoma; malignant pleural mesothelioma (MPM); non-small-cell lung cancer (NSCLC), prostate; Microsatellite Instability-High/deficient mismatch repair (MSI-H/dMMR) tumor (Part 1B and Part 2B) and Human Papilloma Virus (HPV)-positive or Epstein-Barr (EBV)-positive tumor (Part 1B and Part 2B).
* Disease that has progressed after standard therapy for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate, or if no further standard therapy exists; exceptions are in these tumor types in which pembrolizumab single agent may be a standard: NSCLC, head and neck squamous cell cancer (HNSCC), bladder/urothelial cancer, MSI-H/dMMR cancers and melanoma and cervical cancer. In Part 2B pembrolizumab combination expansion cohorts, prior treatment with anti-Programmed cell death protein 1(PD-1)/ Ligand-1 (L1) may not be required. 1) Participants must not have received more than 5 prior lines of therapy for advanced disease including both standards of care and investigational therapies. 2) Participants who received prior PD-1/L1 therapy must fulfill the following requirements (Part 1B [except PK/PD cohort]/ Part 2B):a) Have achieved a CR, PR or SD and subsequently had disease progression while still on PD-1/L1 therapy; b) Have received at least 2 doses of an approved PD-1/L1 inhibitor (by any regulatory authority), c) Have demonstrated disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 within 18 weeks from the last dose of the PD-1/L1 inhibitor. The initial evidence of disease progression is to be confirmed by a second assessment no less than four weeks from the date of the first documented Progressive Disease (PD) (the confirmatory scan could be the Baseline eligibility scan for this study). 3) In Part 2A 5-fluorouracil (FU)/platinum combination with GSK3359609 and pembrolizumab cohort, participants must not have received prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy given as part of multimodal treatment for locally advanced disease).
* Archival tumor tissue obtained at any time from the initial diagnosis to study entry; a fresh tumor biopsy using a procedure that is safe for the participant on a lesion not previously irradiated unless lesion progressed will be required if archival tissue is unavailable.
* Agree to undergo a pre-treatment and on treatment biopsy and have disease amenable to biopsy required in pharmacokinetic (PK) / pharmacodynamics (PD), dose randomized HNSCC, Melanoma dose expansion and Biomarker cohorts..
* Measurable disease per RECIST version 1.1. Palpable lesions that are not measurable by radiographic or photographic evaluations may not be utilized as the only measurable lesion. Any measurable lesion biopsied at Screening cannot be followed as a target/index lesion unless agreed upon by GlaxoSmithKline (GSK).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
* Life expectancy of at least 12 weeks.
* Adequate organ function.
* QT interval corrected for heart rate according to Fridericia's formula (QTcF) <450 milliseconds (msec) or QTcF <480 msec for participants with bundle branch block.
* A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum beta-human chorionic gonadotrophin [beta-hCG] test in females of reproductive potential), and not lactating or reproductive potential agrees to follow one of the options listed in protocol from 30 days prior to the first dose of study medication and until 120 days after the last dose of study treatment.
* Male participants with female partners of child bearing potential must agree to use one of the methods of contraception specified in protocol from time of first dose of study treatment until 120 days after the last dose of study treatment.
* Documented HPV/ EBV-positive tumor as determined by a local laboratory for Part 1B and Part 2B pembrolizumab combination viral-positive expansion cohorts only.
* Documented MSI-H or dMMR-positive tumor as determined by local laboratory for Part 1B and Part 2B pembrolizumab combination MSI-H/dMMR expansion cohorts only.
* ICOS expression result using an analytically validated immunohistochemistry (IHC) assay by central laboratory for Part 1B biomarker cohort only.
* Gene expression (GEX) result using an analytically validated method by central laboratory (Part 1B Biomarker Cohort only).
* PD-L1 combined positive score (CPS) <1 using the Food and Drug Administration (FDA) approved PD-L1 IHC 22C3 pharmdx assay by central laboratory testing for Part 2B HNSCC PD-L1 CPS <1 Cohort. Documented test result from FDA approved PD-L1 IHC 22C3 pharmDx assay in local laboratory, if available, may be accepted in lieu of the central laboratory test result.

Minimum age

18 Years

Maximum age

93 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion Criteria

* Prior treatment with the following therapies:

Â• Anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered.

Â• Part 2B (GSK3359609/pembrolizumab combination): prior pembrolizumab washout is not required.

Â• Prior radiation therapy: permissible if at least one non-irradiated measurable lesion is available for assessment according to RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least two weeks before start of study drug for radiation of any intended use to the extremities for bone metastases and 4 weeks for radiation to the chest, brain, or visceral organs is required. Â• Investigational therapy within 30 days or 5 half-lives of the investigational product (whichever is shorter). At least 14 days must have elapsed between the last dose of investigational agent and the first dose of study drug is administered.

* Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.
* Toxicity from previous anticancer treatment
* Invasive malignancy or history of invasive malignancy other than disease under study within the last two years except: Any other invasive malignancy for which the participant was definitively treated, has been disease-free for <=2 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 trial; and curatively treated non-melanoma skin cancer.
* Central nervous system (CNS) metastases, with the following exception: Â• Participants who have previously-treated CNS metastases, are asymptomatic, and have no requirement for steroids at least 14 days prior to first dose of study drug. Participants with carcinomatous meningitis or leptomeningeal spread are excluded regardless of clinical stability.
* Received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor, recombinant erythropoietin) within 14 days prior to the first dose of GSK3359609.
* Major surgery <=4 weeks before the first dose of study treatment. Participants must have also fully recovered from any surgery (major or minor) and/or its complications before initiating study treatment.
* Active autoimmune disease that has required systemic treatment within the last two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Concurrent medical condition requiring the use of systemic immunosuppressive medications within 7 days before the first dose of study treatment. Physiologic doses of corticosteroids for treatment of endocrinopathies or steroids with minimal systemic absorption, including topical, inhaled, or intranasal corticosteroids may be continued if the participant is on a stable dose.
* Condition requiring treatment with strong inhibitors/inducers of cytochrome p (CYP) 450 3A4 within 7 days prior to first dose of chemotherapy (requirement applies to participants enrolled to Part 2 chemotherapy combination with docetaxel).
* Active infection requiring systemic therapy, known human immunodeficiency virus infection, or positive test for hepatitis B active infection or hepatitis C active infection.
* Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per investigator assessment).
* Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction that required surgery.
* Receipt of any live vaccine within 4 weeks prior to first dose of study treatment.
* Recent history of allergen desensitization therapy within 4 weeks of starting study treatment.
* History of severe hypersensitivity to monoclonal antibodies or to the chemotherapies under investigation including any ingredient used in the formulation.
* History or evidence of cardiac abnormalities.
* History of (current and past) idiopathic pulmonary fibrosis, pneumonitis (for past pneumonitis exclusion only if steroids were required for treatment), interstitial lung disease, or organizing pneumonia. Note: post-radiation changes in the lung related to prior radiotherapy and/or asymptomatic radiation-induced pneumonitis not requiring treatment may be permitted if agreed by the investigator and Medical Monitor.
* Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions.
* Any serious and/or unstable pre-existing medical, psychiatric disorder, or other condition that could interfere with the participant's safety, obtaining informed consent, or compliance to the study procedures.

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

Other

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

23/06/2016

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

5/07/2023

Sample size

Target

Accrual to date

Final

829

Recruitment in Australia

Recruitment state(s)

VIC,WA

Recruitment hospital [1]

GSK Investigational Site - Heidelberg

Recruitment hospital [2]

GSK Investigational Site - Melbourne

Recruitment hospital [3]

GSK Investigational Site - Nedlands

Recruitment postcode(s) [1]

3084 - Heidelberg

Recruitment postcode(s) [2]

3000 - Melbourne

Recruitment postcode(s) [3]

6009 - Nedlands

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

California

Country [2]

United States of America

State/province [2]

Florida

Country [3]

United States of America

State/province [3]

New York

Country [4]

United States of America

State/province [4]

Oklahoma

Country [5]

United States of America

State/province [5]

Pennsylvania

Country [6]

United States of America

State/province [6]

Tennessee

Country [7]

Canada

State/province [7]

Ontario

Country [8]

China

State/province [8]

Shnghai

Country [9]

France

State/province [9]

Bordeaux Cedex

Country [10]

France

State/province [10]

Lyon cedex 08

Country [11]

France

State/province [11]

Paris

Country [12]

France

State/province [12]

Villejuif cedex

Country [13]

Italy

State/province [13]

Toscana

Country [14]

Japan

State/province [14]

Chiba

Country [15]

Japan

State/province [15]

Osaka

Country [16]

Japan

State/province [16]

Tokyo

Country [17]

Netherlands

State/province [17]

Amsterdam

Country [18]

Spain

State/province [18]

Barcelona

Country [19]

Spain

State/province [19]

Madrid

Country [20]

Spain

State/province [20]

MÃ¡ga

Country [21]

Spain

State/province [21]

Sevilla

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

GlaxoSmithKline

Address

Country

Other collaborator category [1]

Commercial sector/industry

Name [1]

Merck Sharp & Dohme LLC

Address [1]

Country [1]

Ethics approval

Ethics application status

Summary

Brief summary

GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in participants with selected, advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab or chemotherapy regimens. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab or GSK3174998 or chemotherapy or pembrolizumab plus chemotherapy or dostarlimab plus cobolimab or Bintrafusp alfa combination dose escalation phase and Part 2B expansion phase with pembrolizumab. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.

Trial website

https://clinicaltrials.gov/study/NCT02723955

Trial related presentations / publications

Turner DC, Wada R, Zhou H, Wang X, de Greef R, Valiathan C, Zhang L, Zhang N, Kuchimanchi M, Chen TT, Ballas M, Visser SAG. Model-based meta-analysis of non-small cell lung cancer with standard of care PD-1 inhibitors and chemotherapy for early development decision making. CPT Pharmacometrics Syst Pharmacol. 2023 Nov;12(11):1751-1763. doi: 10.1002/psp4.12917. Epub 2023 Jan 31.

Public notes

Contacts

Principal investigator

Name

GSK Clinical Trials

Address

GlaxoSmithKline

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)

When will data be available (start and end dates)?

IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.

Available to whom?

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Available for what types of analyses?

How or where can data be obtained?

IPD available at link: http://clinicalstudydatarequest.com

What supporting documents are/will be available?

Type	Other Details	Attachment
Study protocol		https://cdn.clinicaltrials.gov/large-docs/55/NCT02723955/Prot_000.pdf
Statistical analysis plan		https://cdn.clinicaltrials.gov/large-docs/55/NCT02723955/SAP_001.pdf

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02723955

Additional trial details provided through ANZCTR

Accrual to date

Recruiting in Australia

Recruitment state(s)

WA,VIC

Funding & Sponsors

Primary sponsor

Commercial sector/Industry

Primary sponsor name

GlaxoSmithKline

Primary sponsor address

Primary sponsor country

Ethics approval

Ethics application status

Approved

Public notes

Investigators:
Michael Millward, Sir Charles Gairdner Hospital, Western Australia, Nedlands, Australia, 6009
Hui Gan, Austin Health, Victoria, Heidelberg, Australia, 3084
Danny Rischin, Peter MacCallum Cancer Institute, Victoria, Melbourne, Australia, 3000

Contacts

Principal investigator

Title

Name

Address

Country

Phone

Fax

Contact person for public queries

Title

Name

Address

Country

Phone

Fax

GSKClinicalSupportHD@gsk.com

Contact person for scientific queries

Title

Name

Address

Country

Phone

Fax

GSKClinicalSupportHD@gsk.com

Register a trial

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02723955