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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03693612


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


Registration number
NCT03693612
Ethics application status
Date submitted
1/10/2018
Date registered
3/10/2018

Titles & IDs
Public title
GSK3359609 Plus Tremelimumab for the Treatment of Advanced Solid Tumors
Scientific title
A Phase I/II, Open-label, Two Part Study of GSK3359609 in Combination With Tremelimumab in Participants With Selected, Advanced Solid Tumors
Secondary ID [1] 0 0
207871
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - feladilimab
Treatment: Drugs - Tremelimumab
Treatment: Drugs - Docetaxel
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Cetuximab

Experimental: Part 1: feladilimab +tremelimumab - In Part 1, subjects with advanced selected solid tumors will be enrolled. Subjects will be administered escalating doses of feladilimab and tremelimumab in combination. feladilimab will be administered every 3 weeks and tremelimumab will be administered every 3 weeks for 6 doses and every 12 weeks thereafter.

Experimental: Part 2: feladilimab +tremelimumab - In Part 2, subjects with R/R HNSCC who have disease progression after receiving at least one platinum-based chemotherapy and at least one anti-PD-1/PD-L1 will be enrolled. Subjects will be administered feladilimab in combination with tremelimumab at recommended Phase 2 dose as determined from Part 1.

Active comparator: Part 2: SOC - In Part 2, subjects with R/R HNSCC who have disease progression after receiving at least one platinum-based chemotherapy and at least one anti-PD-1/PD-L1 will be enrolled. Subjects will be administered a single agent SOC therapy of either paclitaxel, docetaxel or cetuximab as per the investigators choice.


Treatment: Drugs: feladilimab
feladilimab is humanized anti-ICOS agonist immunoglobulin G (IgG) 4 monoclonal antibody (mAb), which will be administered as an intravenous (IV) infusion once every 3 weeks.

Treatment: Drugs: Tremelimumab
Tremelimumab is humanized anti-CTLA-4 IgG2 mAb, which will be administered as an IV infusion once every 3 weeks for 6 doses, thereafter once every 12 weeks .

Treatment: Drugs: Docetaxel
Docetaxel is a microtubule stabilizer which will be administered as an IV infusion once every 3 weeks at a dose of 75 milligrams per meter square (mg/m\^2).

Treatment: Drugs: Paclitaxel
Paclitaxel is a microtubule stabilizer which will be administered as an IV infusion once weekly at a dose of 80 mg/m\^2.

Treatment: Drugs: Cetuximab
Cetuximab is a recombinant, human/mouse chimeric anti-estimated glomerular filtration rate (EGFR) mAb. Cetuximab will be administered at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Dose Limiting Toxicities (DLTs)-Part 1
Timepoint [1] 0 0
Up to 28 days
Primary outcome [2] 0 0
Number of Participants With DLTs According to Severity-Part 1
Timepoint [2] 0 0
Up to 28 days
Primary outcome [3] 0 0
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1
Timepoint [3] 0 0
Up to 4 years
Primary outcome [4] 0 0
Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1
Timepoint [4] 0 0
Up to 4 years
Primary outcome [5] 0 0
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1
Timepoint [5] 0 0
Up to 4 years
Primary outcome [6] 0 0
Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1
Timepoint [6] 0 0
Up to 4 years
Primary outcome [7] 0 0
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1
Timepoint [7] 0 0
Baseline (Day 1) and Week 4
Primary outcome [8] 0 0
Change From Baseline in Temperature-Part 1
Timepoint [8] 0 0
Baseline (Day 1) and Week 4
Primary outcome [9] 0 0
Change From Baseline in Pulse Rate-Part 1
Timepoint [9] 0 0
Baseline (Day 1) and Week 4
Primary outcome [10] 0 0
Change From Baseline in Respiratory Rate-Part 1
Timepoint [10] 0 0
Baseline (Day 1) and Week 4
Primary outcome [11] 0 0
Change From Baseline in Oxygen Saturation-Part 1
Timepoint [11] 0 0
Baseline (Day 1) and Week 4
Primary outcome [12] 0 0
Number of Participants With Electrocardiogram (ECG) Findings
Timepoint [12] 0 0
Baseline (Pre dose, Day 1) and up to 4 Years
Primary outcome [13] 0 0
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1
Timepoint [13] 0 0
Baseline (Day 1) and Week 4
Primary outcome [14] 0 0
Change From Baseline in Hemoglobin Level-Part 1
Timepoint [14] 0 0
Baseline (Day 1) and Week 4
Primary outcome [15] 0 0
Change From Baseline in Hematocrit Level-Part 1
Timepoint [15] 0 0
Baseline (Day 1) and Week 4
Primary outcome [16] 0 0
Change From Baseline in Erythrocytes Count-Part 1
Timepoint [16] 0 0
Baseline (Day 1) and Week 4
Primary outcome [17] 0 0
Change From Baseline in Albumin and Total Protein Levels-Part 1
Timepoint [17] 0 0
Baseline (Day 1) and Week 4
Primary outcome [18] 0 0
Change From Baseline in Creatinine and Bilirubin Levels-Part 1
Timepoint [18] 0 0
Baseline (Day 1) and Week 4
Primary outcome [19] 0 0
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1
Timepoint [19] 0 0
Baseline (Day 1) and Week 4
Primary outcome [20] 0 0
Change From Baseline in Amylase and Lipase Levels-Part 1
Timepoint [20] 0 0
Baseline (Day 1) and week 4
Primary outcome [21] 0 0
Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1
Timepoint [21] 0 0
Baseline (Day 1) and Week 4
Primary outcome [22] 0 0
Change From Baseline in Specific Gravity of Urine-Part 1
Timepoint [22] 0 0
Baseline (Day 1) and Week 4
Primary outcome [23] 0 0
Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1
Timepoint [23] 0 0
Baseline (Day 1) and Week 4
Primary outcome [24] 0 0
Number of Participants With Abnormal Urinalysis Parameters-Part 1
Timepoint [24] 0 0
Week 4
Primary outcome [25] 0 0
Change From Baseline in Thyroid Stimulating Hormone (TSH) or Thyrotropin-Part 1
Timepoint [25] 0 0
Baseline (Day 1) and Week 4
Primary outcome [26] 0 0
Change From Baseline in Free Triiodothyronine (T3)-Part 1
Timepoint [26] 0 0
Baseline (Day 1) and Week 4
Primary outcome [27] 0 0
Change From Baseline in Free Thyroxine (T4)-Part 1
Timepoint [27] 0 0
Baseline (Day 1) and Week 4
Primary outcome [28] 0 0
Overall Survival-Part 2
Timepoint [28] 0 0
Up to 4 years
Secondary outcome [1] 0 0
Overall Response Rate-Part 1
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
Overall Response Rate-Part 2
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [3] 0 0
Disease Control Rate-Part 1
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
Disease Control Rate-Part 2
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
Progression Free Survival-Part 2
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
Time to Response-Part 2
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
Duration of Response-Part 2
Timepoint [7] 0 0
Up to 4 years
Secondary outcome [8] 0 0
Maximum Observed Plasma Concentration (Cmax) of Feladilimab-Part 1
Timepoint [8] 0 0
Pre-dose, end of infusion and 4 hours post dose at Day 1
Secondary outcome [9] 0 0
Cmax of Tremelimumab-Part 1
Timepoint [9] 0 0
Pre-dose, end of infusion and 4 hours post dose at Day 1
Secondary outcome [10] 0 0
Cmax of Feladilimab-Part 2
Timepoint [10] 0 0
Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25; and 4 hours post-infusion at Week 1
Secondary outcome [11] 0 0
Cmax of Tremelimumab-Part 2
Timepoint [11] 0 0
Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25; and 4 hours post-infusion at Week 1
Secondary outcome [12] 0 0
Minimum Observed Plasma Concentration (Cmin) of Feladilimab-Part 1
Timepoint [12] 0 0
Pre-dose, end of infusion and 4 hours post dose at Day 1
Secondary outcome [13] 0 0
Cmin of Tremelimumab-Part 1
Timepoint [13] 0 0
Pre-dose, end of infusion and 4 hours post dose at Day 1
Secondary outcome [14] 0 0
Cmin of Feladilimab-Part 2
Timepoint [14] 0 0
Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1
Secondary outcome [15] 0 0
Cmin of Tremelimumab-Part 2
Timepoint [15] 0 0
Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1
Secondary outcome [16] 0 0
Area Under the Plasma Concentration-time Curve (AUC[0-t]) of Feladilimab-Part 1
Timepoint [16] 0 0
Pre-dose, end of infusion and 4 hours post dose at Day 1
Secondary outcome [17] 0 0
AUC(0-t) of Tremelimumab-Part 1
Timepoint [17] 0 0
Pre-dose, end of infusion and 4 hours post dose at Day 1
Secondary outcome [18] 0 0
AUC(0-t) of Feladilimab-Part 2
Timepoint [18] 0 0
Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25, and 4 hours post-infusion at Week 1
Secondary outcome [19] 0 0
AUC(0-t) of Tremelimumab-Part 2
Timepoint [19] 0 0
Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1
Secondary outcome [20] 0 0
Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1
Timepoint [20] 0 0
Pre-dose at Week 4, 7, 10 and 13
Secondary outcome [21] 0 0
Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1
Timepoint [21] 0 0
Pre-dose at Week 1, 4, 7, 10 and 13
Secondary outcome [22] 0 0
Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 2
Timepoint [22] 0 0
Up to 2.5 years
Secondary outcome [23] 0 0
Change From Baseline in Free T4-Part 2
Timepoint [23] 0 0
Baseline and up to 2 years
Secondary outcome [24] 0 0
Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 2
Timepoint [24] 0 0
Up to 2.5 years
Secondary outcome [25] 0 0
Number of Participants With AEs, SAEs and AESI-Part 2
Timepoint [25] 0 0
Up to 4 years
Secondary outcome [26] 0 0
Number of Participants With AEs, SAEs, AESIs Based on Severity-Part 2
Timepoint [26] 0 0
Up to 4 years
Secondary outcome [27] 0 0
Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 2
Timepoint [27] 0 0
Up to 4 years
Secondary outcome [28] 0 0
Change From Baseline in SBP and DBP-Part 2
Timepoint [28] 0 0
Baseline and up to 2 years
Secondary outcome [29] 0 0
Change From Baseline in Temperature-Part 2
Timepoint [29] 0 0
Baseline and up to 2 years
Secondary outcome [30] 0 0
Change From Baseline in Pulse Rate-Part 2
Timepoint [30] 0 0
Baseline and up to 2 years
Secondary outcome [31] 0 0
Change From Baseline in Respiratory Rate-Part 2
Timepoint [31] 0 0
Baseline and up to 2 years
Secondary outcome [32] 0 0
Change From Baseline in Oxygen Saturation-Part 2
Timepoint [32] 0 0
Baseline and up to 2 years
Secondary outcome [33] 0 0
Change From Baseline in ECG Measurement-Part 2
Timepoint [33] 0 0
Baseline (Pre-dose) up to 2 years
Secondary outcome [34] 0 0
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 2
Timepoint [34] 0 0
Baseline and up to 2 years
Secondary outcome [35] 0 0
Change From Baseline in Hemoglobin Level-Part 2
Timepoint [35] 0 0
Baseline and up to 2 years
Secondary outcome [36] 0 0
Change From Baseline in Hematocrit Level-Part 2
Timepoint [36] 0 0
Baseline and up to 2 years
Secondary outcome [37] 0 0
Change From Baseline in Erythrocytes Count-Part 2
Timepoint [37] 0 0
Baseline and up to 2 years
Secondary outcome [38] 0 0
Change From Baseline in Albumin and Total Protein Levels-Part 2
Timepoint [38] 0 0
Baseline and up to 2 years
Secondary outcome [39] 0 0
Change From Baseline in Creatinine and Bilirubin Levels-Part 2
Timepoint [39] 0 0
Baseline and up to 2 years
Secondary outcome [40] 0 0
Change From Baseline in ALT, AST, ALP, LDH Levels-Part 2
Timepoint [40] 0 0
Baseline and up to 2 years
Secondary outcome [41] 0 0
Change From Baseline in Amylase and Lipase Levels-Part 2
Timepoint [41] 0 0
Baseline and up to 2 years
Secondary outcome [42] 0 0
Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels -Part 2
Timepoint [42] 0 0
Baseline and up to 2 years
Secondary outcome [43] 0 0
Change From Baseline in Specific Gravity of Urine-Part 2
Timepoint [43] 0 0
Baseline and up to 2 years
Secondary outcome [44] 0 0
Change From Baseline in pH of Urine-Part 2
Timepoint [44] 0 0
Baseline and up to 2 years
Secondary outcome [45] 0 0
Number of Participants With Abnormal Urinalysis Parameters-Part 2
Timepoint [45] 0 0
Up to 2 years
Secondary outcome [46] 0 0
Change From Baseline in TSH-Part 2
Timepoint [46] 0 0
Baseline and up to 2 years
Secondary outcome [47] 0 0
Change From Baseline in Free T3-Part 2
Timepoint [47] 0 0
Baseline and up to 2 years

Eligibility
Key inclusion criteria
* Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.
* Male or female, aged 18 years or older.
* Body weight >=30 kilograms (kg).
* 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: a) Part 1: cutaneous melanoma; HNSCC (oral cavity, larynx, oropharynx, hypopharynx, nasal cavity/paranasal sinuses); non-small cell lung cancer (squamous and non-squamous); urothelial carcinoma of the upper and lower urinary tract; clear cell renal carcinoma; castrate resistant prostate adenocarcinoma. b) Part 2: HNSCC (oral cavity, larynx, pharynx, paranasal sinuses).
* Part 1 only: 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, or where standard therapy is refused. May be anti-PD-1/anti-PD-L1 experienced or naïve.
* Part 2 only: Disease that has progressed after receiving platinum-based chemotherapy (unless medically contraindicated or discontinued due to toxicity) and anti-PD-1/anti-PD-L1 therapy (in combination or as separate lines of therapy in either sequence).
* Measurable disease per RECIST version 1.1 guidelines. 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) score of 0 or 1.
* Adequate organ function.
* A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions apply: a) Not a woman of childbearing potential (WOCBP); or, b) A WOCBP who agrees to follow the contraceptive while receiving study intervention and for at least 180 days after the last dose of study intervention.
* A male subject must agree to use a highly effective contraception while receiving study intervention and for at least 180 days after the last dose of study intervention and refrain from donating sperm during this period.
* Agree to collection of tumor tissue: a) Part 1 and Part 2: Archival tumor tissue collected any time from the initial diagnosis of invasive malignancy; a fresh tumor biopsy will be required if archival specimen is unavailable prior to first dose. b) Part 1 pharmacokinetic/pharmacodynamic cohort(s): Archival tissue as noted in point (a) above. Paired tumor biopsies: tumor tissue collected any time after completion of dosing of the last therapy and prior to first dose and an on-treatment biopsy. c) Part 2: A minimum of 15 subjects from each arm will be required to provide paired tumor biopsies (in addition to the archival tissues as noted in point (a) above): tumor tissue collected any time after completion of dosing of the last therapy and prior to first dose and an on-treatment biopsy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Received prior treatment with the following therapies; calculation is based on date of last therapy to date of first dose of study intervention or SOC: a) Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4 [including tremelimumab] or Inducible T Cell Co-Stimulator (ICOS)-directed therapies at any time; b) >=4 lines of prior anticancer treatment: In subjects that relapse or progress within 1 year from the beginning of adjuvant or concurrent therapy, the adjuvant/concurrent therapy is considered first line therapy; c) Systemic anticancer therapy or investigational therapy within 30 days, or 5 half-lives, whichever is shorter; at least 14 days must have elapsed between the date of the last prior therapy to the date of first dose of study intervention or SOC.
* Prior radiation therapy: permissible if at least one non-irradiated measurable lesion is available for assessment per RECIST v1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. At least 14 days must have elapsed between the date of the last dosage of radiation and the first dose of study intervention/SOC.
* Invasive malignancy or history of invasive malignancy other than disease under study within the last two years, except: a) Any other invasive malignancy for which the subject was definitively treated, has been disease-free for <=2 years and in the opinion of the Investigator and Medical Monitor will not affect the evaluation of the effects of the study intervention or SOC on the currently targeted malignancy, may be included in this clinical study; Curatively treated non-melanoma skin cancer or successfully treated in-situ carcinoma.
* Toxicity from previous anticancer treatment that includes: a) >=Grade 3 toxicity considered related to prior immunotherapy and that led to treatment discontinuation; b) Toxicity related to prior treatment that has not resolved to <=Grade 1 (except alopecia, vitiligo, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be <=Grade 2).
* Central nervous system (CNS) metastases, with the following exception: Subjects with previously treated CNS metastases who are clinically stable and had no requirement for steroids during at least 14 days prior to first dose of study intervention or SOC.
* Major surgery <=28 days of first dose of study intervention or SOC.
* Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years. Replacement therapies which include physiological doses of corticosteroids for treatment of endocrinopathies (i.e., adrenal insufficiency) are not considered systemic treatments.
* Recent history (within 24 weeks) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess.
* Receiving systemic steroids (>=10 milligrams [mg] oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to first dose of study intervention or SOC.
* Prior allogeneic/autologous bone marrow or solid organ transplantation.
* Received live-virus vaccine within 30 days from start of study intervention or SOC.
* Current or history of idiopathic pulmonary fibrosis, pneumonitis (for past, subject is excluded if steroids were required), interstitial lung disease or organizing pneumonia.
* Recent history (within 24 weeks) of uncontrolled, symptomatic ascites, pleural or pericardial effusions.
* History or evidence of cardiac abnormalities within the 24 weeks prior to enrollment which include: a) Serious uncontrolled cardiac arrhythmia or clinically significant electrocardiogram abnormalities including second degree (Type II) or third degree atrioventricular block. b) Cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting, or bypass grafting. c) Symptomatic pericarditis.
* Current unstable liver or biliary disease per Investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
* Active infection requiring systemic therapy.
* Known human immunodeficiency virus infection; 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, the Standard of Care agents, including any ingredient used in the formulation, based on which treatment the subject is to receive.
* Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.
* For subjects receiving SOC: Requires therapy with a medication that may alter the PK of the SOC agent (e.g., strong inducers or inhibitors of cytochrome P (CYP)3A4 for subjects receiving docetaxel or paclitaxel) during the study treatment period. Please refer to the package insert for the agent the subject is to receive.
* For subjects receiving SOC: Any contraindication, per the package insert and/or Institutional guidelines, to the treatment the subject is to receive.

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
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
26/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/09/2021
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario

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
MedImmune LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

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)?
Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Available to whom?
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf


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/NCT03693612

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
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

Contacts
Principal investigator
Title 61 0
Prof
Name 61 0
Danny Rischin
Address 61 0
Peter MacCallum Cancer Centre Melbourne VIC 3000
Country 61 0
Australia
Phone 61 0
Fax 61 0
Email 61 0
Contact person for public queries
Title 62 0
Name 62 0
Address 62 0
Country 62 0
Phone 62 0
Fax 62 0
Email 62 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries
Title 63 0
Name 63 0
Address 63 0
Country 63 0
Phone 63 0
Fax 63 0
Email 63 0
GSKClinicalSupportHD@gsk.com