Source: https://www.mycancergenome.org/content/clinical_trials/NCT03693612/
Timestamp: 2020-03-29 09:05:18
Document Index: 371187668

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Clinical Trial: NCT03693612 - My Cancer Genome
The purpose of this study is to evaluate if the combination of GSK3359609 and tremelimumab is safe and tolerable (Part 1) and provides significant survival benefit to subjects with relapsed/refractory (R/R) Head and Neck Squamous Cell Carcinomas (HNSCC) to warrant further clinical investigation (Part 2). Part 1 (dose escalation) will enroll subjects with advanced, selected solid tumors. Subjects will receive escalating doses of GSK3359609 and tremelimumab in combination in Part 1. Part 2 is randomized expansion and will enroll subjects with R/R HNSCC who have disease progression after receiving at least 1 platinum-based chemotherapy and at least 1 anti-programmed death receptor protein-1 (PD-1)/anti-programmed death-ligand 1 (PD-L1) therapy, whether in combination or separately. In Part 2, subjects will be randomized in a ratio of 2:1 to receive either GSK3359609 in combination with tremelimumab at the recommended Phase 2 dose or investigators choice of a single-agent standard of care (SOC) therapy including paclitaxel, docetaxel or cetuximab. The total duration of subjects in the study will be approximately 4 years.
Brief Title: GSK3359609 Plus Tremelimumab for the Treatment of Advanced Solid Tumors
Official Title: A Phase I/II, Open-label, Two Part Study of GSK3359609 in Combination With Tremelimumab in Participants With Selected, Advanced Solid Tumors
ORG STUDY ID: 207871
NCT ID: NCT03693612
GSK3359609 Part 2: GSK3359609+tremelimumab
Tremelimumab Part 2: GSK3359609+tremelimumab
Docetaxel Part 2: SOC
Paclitaxel Part 2: SOC
Cetuximab Part 2: SOC
Part 1: GSK3359609+tremelimumab Experimental In Part 1, subjects with advanced selected solid tumors will be enrolled. Subjects will be administered escalating doses of GSK3359609 and tremelimumab in combination. GSK3359609 will be administered every 3 weeks and tremelimumab will be administered every 3 weeks for 6 doses and every 12 weeks thereafter.
Part 2: GSK3359609+tremelimumab Experimental 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 GSK3359609 in combination with tremelimumab at recommended Phase 2 dose as determined from Part 1.
Part 2: SOC Active Comparator 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.
-  Capable of giving signed informed consent/assent which includes compliance with the
-  Male or female, aged 18 years or older.
-  Body weight >=30 kilograms (kg).
-  Histological or cytological documentation of an invasive malignancy that was diagnosed
-  Part 1 only: Disease that has progressed after standard therapy for the specific tumor
-  Part 2 only: Disease that has progressed after receiving platinum-based chemotherapy
-  Measurable disease per RECIST version 1.1 guidelines. Palpable lesions that are not
-  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
-  A female subject is eligible to participate if she is not pregnant, not breastfeeding,
-  A male subject must agree to use a highly effective contraception while receiving
-  Agree to collection of tumor tissue: a) Part 1 and Part 2: Archival tumor tissue
-  Received prior treatment with the following therapies; calculation is based on date of
-  Prior radiation therapy: permissible if at least one non-irradiated measurable lesion
-  Invasive malignancy or history of invasive malignancy other than disease under study
-  Toxicity from previous anticancer treatment that includes: a) >=Grade 3 toxicity
-  Central nervous system (CNS) metastases, with the following exception: Subjects with
-  Major surgery <=28 days of first dose of study intervention or SOC.
-  Autoimmune disease (current or history) or syndrome that required systemic treatment
-  Recent history (within 24 weeks) of gastrointestinal obstruction that required
-  Receiving systemic steroids (>=10 milligrams [mg] oral prednisone or equivalent) or
-  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
-  Recent history (within 24 weeks) of uncontrolled, symptomatic ascites, pleural or
-  History or evidence of cardiac abnormalities within the 24 weeks prior to enrollment
-  Known human immunodeficiency virus infection; positive test for hepatitis B active
-  History of severe hypersensitivity to monoclonal antibodies, the Standard of Care
-  Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric
-  For subjects receiving SOC: Requires therapy with a medication that may alter the PK
-  For subjects receiving SOC: Any contraindication, per the package insert and/or
Measure: Number of subjects with dose limiting toxicities (DLTs)-Part 1
Description: An adverse event (AE) is considered to be a DLT if it is considered by the investigator to be clinically relevant and is attributed to the study treatment during the 28-day DLT observation period and meets at least 1 of the pre-specified criteria.
Measure: Overall response rate-Part 1
Description: Overall response rate is defined as percentage of subjects with confirmed complete response or partial response at any time as per response evaluation criteria in solid tumors (RECIST) version 1.1.
Measure: Overall response rate-Part 2
Description: Overall response rate is defined as percentage of subjects with confirmed complete response or partial response at any time as per RECIST version 1.1.
Measure: Disease control rate-Part 1
Description: Disease control rate is defined as percentage of subjects with confirmed complete response or partial response or at least 18 weeks of stable disease.
Measure: Disease control rate-Part 2
Measure: Progression free survival-Part 2
Description: For Part 2, progression free survival duration is defined as the time from the date of randomization to first documented evidence of disease progression or death (regardless of cause of death), whichever comes first.
Measure: Time to response-Part 2
Description: Time to response is defined as the time from the first dose to the first documented evidence of complete response (CR) or partial response (PR) for subjects with a confirmed CR or PR.
Measure: Duration of response-Part 2
Description: Duration of response is defined as time from the first documented evidence of response until the first documented sign of disease progression or death among subjects who achieve a response (CR or PR).
Measure: Maximum observed plasma concentration (Cmax) of GSK3359609-Part 1
Time Frame: 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
Description: Blood samples will be collected at indicated time points for pharmacokinetic assessment.
Measure: Cmax of tremelimumab-Part 1
Time Frame: 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
Measure: Cmax of GSK3359609-Part 2
Measure: Cmax of tremelimumab-Part 2
Measure: Minimum observed plasma concentration (Cmin) of GSK3359609-Part 1
Measure: Cmin of tremelimumab-Part 1
Measure: Cmin of GSK3359609-Part 2
Measure: Cmin of tremelimumab-Part 2
Measure: Area under the plasma concentration-time curve AUC(0-t) of GSK3359609-Part 1
Measure: AUC(0-t) of GSK3359609-Part 2
Time Frame: 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
Measure: AUC(0-t) of tremelimumab-Part 1
Measure: AUC(0-t) of tremelimumab-Part 2
Measure: Number of subjects with anti-drug antibodies against GSK3359609-Part 1
Description: Serum samples will be collected and tested for the presence of antibodies to GSK3359609.
Measure: Number of subjects with anti-drug antibodies against GSK3359609-Part 2
Measure: Number of subjects with anti-drug antibodies against tremelimumab-Part 1
Description: Serum samples will be collected and tested for the presence of antibodies to tremelimumab.
Measure: Number of subjects with anti-drug antibodies against tremelimumab-Part 2
Measure: Number of subjects with AEs, SAEs and AESI-Part 2
Description: An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study intervention/SOC, whether or not considered related to the study intervention/SOC. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the subject or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before.
Measure: Severity of AEs, SAEs, AESI and AE/SAEs leading to dose modifications/delays/withdrawals-Part 2
Description: The severity of all toxicities will be graded using the NCI-CTCAE (version 5.0).
Measure: Change from Baseline in SBP and DBP-Part 2
Time Frame: Baseline and up to 2 years
Description: SBP and DBP will be measured after 5 minutes of rest for the subject.
Measure: Change from Baseline in temperature-Part 2
Description: Temperature will be measured after 5 minutes of rest for the subject.
Measure: Change from Baseline in pulse rate-Part 2
Description: Pulse rate will be measured after 5 minutes of rest for the subject.
Measure: Change from Baseline in respiratory rate-Part 2
Description: Respiratory rate will be measured after 5 minutes of rest for the subject.
Measure: Change from Baseline in oxygen saturation-Part 2
Description: Oxygen saturation will be measured using pulse oximetry after 5 minutes of rest for the subject.
Measure: Change from Baseline in ECG measurement-Part 2
Time Frame: Baseline and Day 1
Description: Single 12-lead ECG will be obtained using an automated ECG machine.
Measure: Change from Baseline in neutrophil, lymphocyte, monocyte, eosinophil, basophil and platelet count-Part 2
Description: Blood samples will be collected to assess change from Baseline in neutrophil, lymphocyte, monocyte, eosinophil, basophil and platelet count.
Measure: Change from Baseline in hemoglobin level-Part 2
Description: Blood samples will be collected to assess change from Baseline in hemoglobin level.
Measure: Change from Baseline in hematocrit level-Part 2
Description: Blood samples will be collected to assess change from Baseline in hematocrit level.
Measure: Change from Baseline in RBC count-Part 2
Description: Blood samples will be collected to assess change from Baseline in RBC count.
Measure: Change from Baseline in albumin and total protein levels-Part 2
Description: Blood samples will be collected to assess change from Baseline in albumin and total protein levels.
Measure: Change from Baseline in creatinine and bilirubin levels-Part 2
Description: Blood samples will be collected to assess change from Baseline in creatinine and bilirubin levels.
Measure: Change from Baseline in ALT, AST, ALP, LDH, amylase and lipase levels-Part 2
Description: Blood samples will be collected to assess change from Baseline in ALT, AST ALP, LDH, amylase and lipase levels.
Measure: Change from Baseline in BUN, glucose, potassium, sodium and calcium-Part 2
Description: Blood samples will be collected to assess change in levels of BUN, glucose, potassium, sodium and calcium from Baseline.
Measure: Change from Baseline in specific gravity of urine-Part 2
Description: Urine samples will be collected to assess change from Baseline in specific gravity of urine.
Measure: Change from Baseline in pH of urine-Part 2
Description: Urine samples will be collected to assess change from Baseline in pH of urine.
Measure: Change from Baseline in glucose, protein, blood and ketone levels in urine-Part 2
Description: Urine samples will be collected to assess change from Baseline in glucose, protein, blood and ketone levels in urine.
Measure: Change from Baseline in TSH-Part 2
Description: Blood samples will be collected to assess change from Baseline in TSH.
Measure: Change from Baseline in free T3-Part 2
Description: Blood samples will be collected to assess change from Baseline in free T3.
Measure: Change from Baseline in free T4-Part 2
Description: Blood samples will be collected to assess change from Baseline in free T4.
urothelial carcinoma of the upper and lower urinary tract
castrate resistant prostate adenocarcinoma