Professor Atkinson - Clinical Trials

Clinical Trial Involvement

Investigator Initiated

Natural history and properties of naevi in advanced melanoma patient receiving treatment. (Investigators Dr. Victoria Atkinson and Dr. Helmut Schaider)

ASBREAK: Effect of combined acetylsalicylic acid (Aspirin) and BRAF/MEK inhibition in melanoma patients with advance disease. (Lead Principal Investigator, Dr. Victoria Atkinson and Dr. Helmut Schaider)

ABC brain: A phase II study of nivolumab and nivolumab combined with ipilimumab in patients with melanoma brain metastases (Principal Investigators, Dr. Georgina Long, Dr. Grant McArthur and Dr. Victoria Atkinson-supported by ANZMTG and MIA)

BRAF brain: An Open-Label, Single-Cohort Study of Dabrafenib (GSK2118436) in Combination with Whole Brain Radiotherapy in the Treatment of Participants with Newly Diagnosed BRAF Mutation-Positive Metastatic Melanoma to the Brain (Principal Investigators Dr. Victoria Atkinson and Dr. Matthew Foote)

COMBI-RT- An open-label, single-arm, phase I/II, multicentre study to evaluate the safety and efficacy of the combination of dabrafenib, trametinib and palliative radiotherapy in patients with unresectable (stage IIIc) and metastatic (stage IV) BRAF V600E/K mutation-positive cutaneous melanoma. (Co-Investigator Supported by ANZMTG)

STOP- GAP-A randomised phase III study of duration of anti-Pd-1 therapy in metastatic melanoma. (In collaboration with the Canadian Collaborative Trials Group)

Principal Investigator: Pharmacy Sponsored trials

BRIM 3 NO20525- BRIM 3: A Randomized, Open-label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients with Unresectable Stage IIIC or Stage IV Melanoma

SUMMIT 1- (H8K-MC-JZAO / SUMMIT-1)- Phase III trial evaluating tasisulam (LY573636-sodium or diarylacylsulfonamide), an investigational, small-molecule anti-cancer compound, as a second-line treatment for those with unresectable or metastatic melanoma.

SAVE-ONCO: Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy

LAP-07: Randomised multicenter phase III study in patients with locally advanced adenocarcinoma of the pancreas: gemcitabine with or without chemoradiotherapy and with or without erlotinib.

MORAb-004-201-MEL: a multicenter Phase 2 study in advanced malignant melanoma. The study tests two doses of MORAb-004 as a single agent in patients who have failed other therapies.

AVAglio-BO20910: Phase 3 trial of bevacizumab plus temozolomide and radiotherapy in newly diagnosed glioblastoma multiforme.

RAISE: Ramucirumab Plus FOLFIRI Improved Survival in Metastatic Colorectal Cancer following Progression on a Bevacizumab-Based Regimen

ATTACHE: A Trial in the Timing of Surgery and Adjuvant Chemotherapy for Hepatic Metastases from Colorectal Cancer

EMR 200066-007: A multicentre, open label, randomized Phase II trial of the MEK inhibitor pimasertib or dacarbazine in previously untreated subjects with N-Ras mutated locally advanced

COMBI-D: Phase III, randomized, double-blinded study comparing the combination of the BRAF inhibitor, GSK2118436 and the MEK inhibitor, GSK1120212 to each single agent combined with placebo in subjects with advanced (Stage IIIc) or metastatic (Stage IV) BRAF V600E/K mutation-positive melanoma

COMBI-AD: A phase III randomized double-blind study of dabrafenib (GSK2118436) in Combination with trametinib (GSK1120212) versus two placebos in the Adjuvant treatment
of high-risk BRAF V600 mutation-positive melanoma after surgical resection.

COMBI-MB: BRF117277 (COMBI-MB): A Phase II, Open-Label, Multicentre Study of Dabrafenib plus Trametinib in Subjects with BRAF Mutation-Positive Melanoma that has Metastasized to the Brain.

CA184-169: A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg vs at 10 mg/kg in Subjects with Previously Treated or Untreated Unresectable or Advance Melanoma.

CA209-066: A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects with Previously Untreated Unresectable or Metastatic Melanoma

CA209-067: A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab Versus Ipilimumab Monotherapy in Subjects with Previously Untreated Unresectable or Metastatic Melanoma.

Co-BRIM: A Phase III, Double blind, and Placebo controlled study of Vemurafenib + Placebo versus Vemurafenib in Combination with GDC-0973 in previously untreated BRAFV600-mutation positive patient with unresectable locally advanced or metastatic melanoma.

DESCRIBE-Safety and Efficacy Analysis of Patients from the Dabrafenib Named Patient Programme in Patients with V600 BRAF-Mutated Metastatic Melanoma

NEMO: The NEMO trial (NRAS melanoma and MEK inhibitor): A randomized Phase III, open label, multicenter, two-arm study comparing the efficacy of MEK162 versus dacarbazine in patients with advanced unresectable or metastatic NRAS mutation-positive melanoma

COLOMBUS: A Phase III randomized, 3-arm, partially blinded, placebo controlled, multicenter, study of the Combination of LGX818 plus MEK162 compared with vemurafenib, and of LGX818 compared with vemurafenib for the treatment of patients with unresectable stage IIIB, IIIC or Stage IV melanoma with BRAF V600 mutation

A Phase 1b/2, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With MK-3475 for Treatment of Previously Untreated, Unresected, Stage IIIB to IVM1c Melanoma

DECRIBEII: Dabrafenib-Trametinib Combination Metastatic Melanoma Named Patient Programme Retrospective Chart Review.

MK3475-029: A Phase I/II Clinical trial to study the safety and tolerability of MK-3475 and Pegylated Interferon alfa-2b (PEG-IFN) and MK-3475 + Ipilimumab (IPI) in Subjects with Advanced Melanoma (MEL) and renal Cell Carcinoma (RCC) (KEYNOTE 029)

MK3475-022: A Study of the Safety and Efficacy of Pembrolizumab (MK-3475) in Combination with Trametinib and Dabrafenib in Participants with Advanced Melanoma (MK-3475-022/KEYNOTE-022)

MK3475-054: Adjuvant immunotherapy with anti-PD-1 monoclonal antibody Pembrolizumab (MK-3475) versus placebo after complete resection of high-risk Stage III melanoma: A randomized, double- blind Phase 3 trial of the EORTC Melanoma Group.

EMR 100070-003-A Phase II, open-label, multicenter trial to investigate the clinical activity and safety of MSB0010718C in subjects with Merkel cell carcinoma

BGB 283-A Phase IA, Open-Label, Multiple-Dose, Dose Escalation Study to Investigate the Safety and Pharmacokinetics of the B-RAF Inhibitor BGB-283 in Subjects with Solid Tumors

CA209-238: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Nivolumab versus Ipilimumab after Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects who are at High Risk for Recurrence.

MK3475-252: A Phase 3 Randomised, Double Blind, Placebo-controlled Study of Pembrolizumab (MK3475) in Combination with Epacadostat or Placebo in Subjects with Unresectable or Metastatic Melanoma (Keynote-252/Echo-301).

BGB-A317: Phase 1 dose escalation and expansion study of the anti-PD1 BGB-317A in subjects with advanced tumours

13Y-MC-JPBO: Phase II study of abemaciclib inpatients with brain metastasis secondary to HR+ breast cancer, NSCLC or melanoma

TACTi-Mel: Phase 1 dose escalation study in patients with unresectable or metastatic melanoma receiving IMP321 (LAG-31g fusion protein) as adjunctive therapy to anti-PD-1 therapy with pembrolizumab.

CA 209-401: Clinical trial of Nivolumab Combined with Ipilimumab Followed by Nivolumab Monotherapy as First-line Therapy of Subjects with Histologically Confirmed Stage III Unresectable or Stage IV Melanoma.

CA209-511: Phase IIIB/IV, Randomised, Double Blinded, Study of Nivolumab 3mg/kg in combination with Ipilimumab 1mg/kg in combination with Ipilimumab 3mg/kg in Subjects with Previously Untreated, Unresectable or Metastatic Melanoma.

EMR200647-001: A Phase 1, open label, multiple ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of MSB0011359C in subjects with metastatic or locally advanced solid tumours and expansion to selected indications.

CA0170-055: A Phase II/III study of BMS-986205 combined with Nivolumab versus Nivolumab in patients with unresectable metastatic melanoma.

CA224-020: (Part D) A Phase1/2a Dose escalation and cohort expansion study of the safety, tolerability and Efficacy of the Anti-LAG3 monoclonal antibody BMS986016 administered alone and in combination with the Anti-PD1 monoclonal antibody Nivolumab in advanced solid tumours.

COMBI-I: A randomised Phase III study comparing the combination of PDR001, Dabrafenib and Trametinib versus Placebo, Dabrafenib and Trametinib in patients with unresectable or metastatic BRAF V600 mutant melanoma.

CA209-915: A Phase 3 randomised study or Adjuvant immunotherapy with Nivolumab combined with ipilimumab versus Nivolumab monotherapy in complete resection of Stage IIIB/C or Stage IV melanoma.

CO39721-Cobimetinib plus Atezolizumab in patients with advanced melanoma whose melanoma has worsened during or after treatment with previous immunotherapy and Atezolizumab monotherapy in Untreated Melanoma.

TRILOGY-Atezolizumab plus Cobimetinib and Vemurafenib versus Placebo plus Cobimetinib and Vemurafenib in previously untreated Bv600 Mutation positive patients with metastatic or unresectable locally advanced melanoma.

IMSPIRE-Cobimetinib Plus Atezolizumab versus Pembrolizumab in participants with previously untreated advanced BRAFv600 wild type melanoma.

MGA-271-Enoblitztuzumab in combination with Pembrolizumab in refractory cancer.

PISCES-Multicentre Phase II, open label trial of intra-tumoural pIL-12 plus electroporation in combination with intravenous pembrolizumab or nivolumab treatment.

Andecaliximab with mFLOFOX6 as first line treatment for advanced gastric or gastroesophageal junction adenocarcinoma.

KEYNOTE-062- Pembrolizumab as first line monotherapy and combination therapy for the treatment of Advanced gastric or gastroesophageal adenocarcinoma.

KEYNOYE-177-Pembrolizumab vs Standard therapy in participant with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) Stage IV Colorectal cancer.

A Phase 1b/2 Study of PV-10 Intralesional Injection in Combination with Systemic Immune Checkpoint Inhibition for Treatment of Metastatic Melanoma

DESCRIBE3: A retrospective analysis of Dabrafenib and or Dabrafenib and Trametinib in patient with metastatic melanoma.

KEYNOTE 716-Adjuvant therapy with Pembrolizumab versus placebo in resected high-risk Stage II melanoma: A randomised study.

CA224-020-A Phase 1/2a dose escalation and cohort expansion study of the safety, tolerability and efficacy of an Anti-LAG3 monoclonal antibody (BMS986016) administered alone and in combination with nivolumab in advanced solid tumours

CA224-047-A randomised, double blind phase 2/3 study of relatimab combined with nivolumab versus nivolumab in participants with previously untreated or unresectable melanoma.

CA045-001-Phase 3 randomised, open label study of NKTR-214 combined with nivolumab versus nivolumab in participant’s with previously untreated or unresectable melanoma.

COMBI-Aplus: Open-label, phase IIIB study of dabrafenib in combination with trametinib in the adjuvant treatment of Stage III BRAFv600 mutation positive melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adapted pyrexia AE-management algorithm(Plus)

I8X-JECA-A phase 1 study of LY3200882 in patients with solid tumours

CA209-577-A randomised, multicentre, double blind Phase III study of adjuvant nivolumab or placebo in subjects with resected oesophageal or gastroesophageal junction cancer.