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BRAF positive Melanoma Stage IV

GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positiveMelanoma

This study is ongoing, but not recruiting participants.

Trial website: https://clinicaltrials.gov/ct2/show/NCT01245062?term=BRAF+positive&cond=Melanoma+Stage+IV&cntry1=PA%3ANZ&rank=2

Trial purpose: This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Subjects who have received up to one prior regimen of chemotherapy in the advanced or metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1 randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy arm). The primary endpoint for the statistical analysis will be a comparison of progression free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have progression on chemotherapy will be offered the option to receive GSK1120212.

CLL14 BO25323 Chronic lymphocytic leukaemia (CLL) in previously untreated patients with coexisting medical conditions

A Study to Compare the Efficacy and Safety of Obinutuzumab + Venetoclax (GDC-0199) Versus Obinutuzumab + Chlorambucil in Participants With Chronic Lymphocytic Leukemia

This study is currently recruiting participants.

Trial website: https://clinicaltrials.gov/ct2/show/NCT02242942 

Trial purpose: This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The anticipated time on study treatment will be approximately one year and the follow-up period will be up to 5 years.

CNS lymphoma NHL 24

Rituximab in Primary Central Nervous system Lymphoma. A randomized HOVON / ALLG intergroup study

Trial website: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-014722-42/NL

Main objective: Assess the effect of the addition of rituximab to standard chemotherapy for PCNSL

EGFR Brain ABT-414

A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)

This study is currently recruiting participants.

Trial website: https://clinicaltrials.gov/ct2/show/NCT02573324?term=EGFR+Brain+ABT-414&cond=GBM&rank=1

Trial purpose: This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) prolongs progression free survival (PFS) and overall survival (OS) in participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification.

In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in subjects with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.

 

ET743-OVC-3006 Ovarian Cancer

A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

This study is currently recruiting participants.

Trial website: https://clinicaltrials.gov/show/NCT01846611 

Trial purpose: The purpose of this study is to assess the efficacy and safety of trabectedin+DOXIL as a third-line chemotherapy regimen (treatment) in patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinum-based chemotherapy.

 

MK 3475 Head and Neck

Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)

This study is currently recruiting participants.

Trial website: https://clinicaltrials.gov/ct2/show/NCT03040999?term=MK+3475&cond=Head+and+Neck&cntry1=PA%3ANZ&rank=2 

Trial purpose: The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR).

OUTBACK cervical cancer

Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer

This study is currently recruiting participants.

Trial website: https://clinicaltrials.gov/ct2/show/NCT01414608 

Trial purpose: This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with cervical cancer has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. External radiation therapy uses high-energy x rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kills more tumor cells.

Phase 1B solid tumours

A Phase 1A/1B, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Preliminary Antitumor Activities of the B RAF Inhibitor BGB 283 in Subjects with Solid Tumors

Trial website: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367264 

Primary outcome: The safety of BGB 283 will be assessed throughout the study by monitoring Adverse Events (AEs) per the National Cancer Institute Common Toxicity Criteria for AEs (NCI-CTCAE), serious adverse events (SAEs), physical examination, and laboratory measurements.

Treatments for haematological disease and secondary hypogammaglobulinemia

A randomised controlled feasibility trial comparing the efficacy of prophylactic intravenous immunoglobulin with prophylactic antibiotics in patients with acquired hypogammaglobulinemia secondary to haematological malignancies.

This study is currently recruiting participants.

Trial website: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372003

Primary outcome: Proportion of patients alive who remain on assigned treatment arm at 12 months following randomisation. This will be assessed using medical records. 

Vaccine Melanoma study

A phase I/II trial of immunisation with autologous dendritic cells loaded with NY-ESO-1 and Alpha-galactosylceramide in patients with high-risk surgically resected stage II, III or IV melanoma

Trial website: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363134 

Primary outcome: Proportion of patients alive who remain on assigned treatment arm at 12 months following randomisation. This will be assessed using medical records.

Last updated 8 August 2017.