Clinical Trials /

GSK3359609 Plus Tremelimumab for the Treatment of Advanced Solid Tumors

NCT03693612

Description:

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.

Related Conditions:
  • Clear Cell Renal Cell Carcinoma
  • Cutaneous Melanoma
  • Head and Neck Squamous Cell Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Prostate Adenocarcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: 207871
  • NCT ID: NCT03693612

Conditions

  • Neoplasms

Interventions

DrugSynonymsArms
GSK3359609Part 2: GSK3359609+tremelimumab
TremelimumabPart 2: GSK3359609+tremelimumab
DocetaxelPart 2: SOC
PaclitaxelPart 2: SOC
CetuximabPart 2: SOC

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Part 1: GSK3359609+tremelimumabExperimentalIn 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.
  • GSK3359609
  • Tremelimumab
Part 2: GSK3359609+tremelimumabExperimentalIn 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.
  • GSK3359609
  • Tremelimumab
Part 2: SOCActive ComparatorIn 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.
  • Docetaxel
  • Paclitaxel
  • Cetuximab

Eligibility Criteria

        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.

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of subjects with dose limiting toxicities (DLTs)-Part 1
Time Frame:Up to 28 days
Safety Issue:
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.

Secondary Outcome Measures

Measure:Overall response rate-Part 1
Time Frame:Up to 4 years
Safety Issue:
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
Time Frame:Up to 4 years
Safety Issue:
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
Time Frame:Up to 4 years
Safety Issue:
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
Time Frame:Up to 4 years
Safety Issue:
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:Progression free survival-Part 2
Time Frame:Up to 4 years
Safety Issue:
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
Time Frame:Up to 4 years
Safety Issue:
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
Time Frame:Up to 4 years
Safety Issue:
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
Safety Issue:
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
Safety Issue:
Description:Blood samples will be collected at indicated time points for pharmacokinetic assessment.
Measure:Cmax 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
Safety Issue:
Description:Blood samples will be collected at indicated time points for pharmacokinetic assessment.
Measure:Cmax of tremelimumab-Part 2
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
Safety Issue:
Description:Blood samples will be collected at indicated time points for pharmacokinetic assessment.
Measure:Minimum observed plasma concentration (Cmin) 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
Safety Issue:
Description:Blood samples will be collected at indicated time points for pharmacokinetic assessment.
Measure:Cmin 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
Safety Issue:
Description:Blood samples will be collected at indicated time points for pharmacokinetic assessment.
Measure:Cmin 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
Safety Issue:
Description:Blood samples will be collected at indicated time points for pharmacokinetic assessment.
Measure:Cmin of tremelimumab-Part 2
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
Safety Issue:
Description:Blood samples will be collected at indicated time points for pharmacokinetic assessment.
Measure:Area under the plasma concentration-time curve AUC(0-t) 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
Safety Issue:
Description:Blood samples will be collected at indicated time points for pharmacokinetic assessment.
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
Safety Issue:
Description:Blood samples will be collected at indicated time points for pharmacokinetic assessment.
Measure:AUC(0-t) 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
Safety Issue:
Description:Blood samples will be collected at indicated time points for pharmacokinetic assessment.
Measure:AUC(0-t) of tremelimumab-Part 2
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
Safety Issue:
Description:Blood samples will be collected at indicated time points for pharmacokinetic assessment.
Measure:Number of subjects with anti-drug antibodies against GSK3359609-Part 1
Time Frame:Up to 2.5 years
Safety Issue:
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
Time Frame:Up to 2.5 years
Safety Issue:
Description:Serum samples will be collected and tested for the presence of antibodies to GSK3359609.
Measure:Number of subjects with anti-drug antibodies against tremelimumab-Part 1
Time Frame:Up to 2.5 years
Safety Issue:
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
Time Frame:Up to 2.5 years
Safety Issue:
Description:Serum samples will be collected and tested for the presence of antibodies to tremelimumab.
Measure:Number of subjects with AEs, SAEs and AESI-Part 2
Time Frame:Up to 4 years
Safety Issue:
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
Time Frame:Up to 4 years
Safety Issue:
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
Safety Issue:
Description:SBP and DBP will be measured after 5 minutes of rest for the subject.
Measure:Change from Baseline in temperature-Part 2
Time Frame:Baseline and up to 2 years
Safety Issue:
Description:Temperature will be measured after 5 minutes of rest for the subject.
Measure:Change from Baseline in pulse rate-Part 2
Time Frame:Baseline and up to 2 years
Safety Issue:
Description:Pulse rate will be measured after 5 minutes of rest for the subject.
Measure:Change from Baseline in respiratory rate-Part 2
Time Frame:Baseline and up to 2 years
Safety Issue:
Description:Respiratory rate will be measured after 5 minutes of rest for the subject.
Measure:Change from Baseline in oxygen saturation-Part 2
Time Frame:Baseline and up to 2 years
Safety Issue:
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
Safety Issue:
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
Time Frame:Baseline and up to 2 years
Safety Issue:
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
Time Frame:Baseline and up to 2 years
Safety Issue:
Description:Blood samples will be collected to assess change from Baseline in hemoglobin level.
Measure:Change from Baseline in hematocrit level-Part 2
Time Frame:Baseline and up to 2 years
Safety Issue:
Description:Blood samples will be collected to assess change from Baseline in hematocrit level.
Measure:Change from Baseline in RBC count-Part 2
Time Frame:Baseline and up to 2 years
Safety Issue:
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
Time Frame:Baseline and up to 2 years
Safety Issue:
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
Time Frame:Baseline and up to 2 years
Safety Issue:
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
Time Frame:Baseline and up to 2 years
Safety Issue:
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
Time Frame:Baseline and up to 2 years
Safety Issue:
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
Time Frame:Baseline and up to 2 years
Safety Issue:
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
Time Frame:Baseline and up to 2 years
Safety Issue:
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
Time Frame:Baseline and up to 2 years
Safety Issue:
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
Time Frame:Baseline and up to 2 years
Safety Issue:
Description:Blood samples will be collected to assess change from Baseline in TSH.
Measure:Change from Baseline in free T3-Part 2
Time Frame:Baseline and up to 2 years
Safety Issue:
Description:Blood samples will be collected to assess change from Baseline in free T3.
Measure:Change from Baseline in free T4-Part 2
Time Frame:Baseline and up to 2 years
Safety Issue:
Description:Blood samples will be collected to assess change from Baseline in free T4.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:GlaxoSmithKline

Trial Keywords

  • advanced solid tumor
  • Head and Neck Squamous Cell Carcinoma
  • standard of care
  • GSK3359609
  • urothelial carcinoma of the upper and lower urinary tract
  • non-small cell lung cancer
  • cutaneous melanoma
  • Tremelimumab
  • clear cell renal carcinoma
  • castrate resistant prostate adenocarcinoma

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