Trials posted here are for informational purposes only. NeuroEndocrine Cancer Australia does not endorse any particular research study and is not responsible for the accuracy of the information provided by the investigator or the accuracy of the information provided by the searchable databases.
A Randomized, Multi-center, Open-label, Active-controlled Phase 3 Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) Versus Octreotide LAR or Lanreotide ATG in Patients With GEP-NET
The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.
Phase: Phase 3
Sponsor: Camurus AB
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Read more here.
Study to look at well-differentiated advanced Grade 2 and Grade 3 somatostatin receptor positive (SSTR+) neuroendocrine tumors of gastroenteric or pancreatic origin (G2 & G3 GEP-NETs)
Investigational treatment
Targeted Radionuclide Therapy with n.c.a. Lutetium-177-Edotreotide, consisting of the highly pure medical radioisotope, no-carrier-added (n.c.a.) Lutetium-177, used to destroy tumor cells, and the molecule Edotreotide, which targets neuroendocrine tumor-specific receptors and delivers the medical radioisotope to the tumor site.
What is Targeted Radionuclide Therapy?
In contrast to external radiotherapy, where radiation is applied from outside the body, Targeted Radionuclide Therapy isdefined by the infusion of a radiopharmaceutical into the body which precisely recognizes and destroys tumor cells while healthy surrounding tissue is minimally affected.
Comparator treatment
Standard therapy with either CAPTEM (chemotherapy) or everolimus (immunosuppressive cancer therapy) or FOLFOX (chemotherapy), determined by the doctor based on individual benefit-risk assessment and according to institutional protocols, local prescribing information, local regulations or local guidelines.
Study objectives
Evaluate efficacy, safety and impact on quality of life.
Contact:
Peter MacCallum Cancer Centre
Melbourne VIC 3000, Australia
Principle Investigator: A/Prof Michael Michael
Contact: (03) 8559 5000
Royal North Shore Hospital
St Leonards / Sydney NSW 2065, Australia
Principle Investigator: A/Prof Nick Pavlakis
Contact: (02) 9926 7111
PARP Inhibitor With 177Lu-DOTA-Octreotate PRRT in Patients With Neuroendocrine Tumours (PARLuNET)
PARLuNET is a phase 1 dose-escalation study designed to evaluate the safety and tolerability of talazoparib (PARP Inhibitor) in combination with 177Lu-DOTA-Octreotate peptide receptor radionuclide therapy (PRRT) in patients with metastatic pancreatic and mid gut neuroendocrine tumour (NET).
Patients will receive 1 cycle of 177Lu-DOTA-Octreotate alone followed by 3 cycles of 177Lu-DOTA-Octreotate combined with 5 days of talazoparib.
This trial is looking to recruit 24 patients and if you would like to know if you are eligible, please ask your doctor to assess the inclusion criteria listed at PARP Inhibitor With 177Lu-DOTA-Octreotate PRRT in Patients With Neuroendocrine Tumours – Full Text View – ClinicalTrials.gov
Contact:
Grace Kong 03 8559 5000 or NMResearch@petermac.org
Research Manager: 03 8559 6602
Recruiting: NMResearch@petermac.org
Locations: Australia, Victoria
Peter MacCallum Cancer Centre, Melbourne, Victoria 3000, Australia
Sponsors and Collaborators
Peter MacCallum Cancer Centre, Australia
Combination Immunotherapy in Rare Cancers Under InvesTigation (MOST-CIRCUIT)
Brief Study Description:
The four tumour streams that will be studied in this protocol are based on immunotherapy sensitive rare cancers from CA209-538 which will be further investigated under this protocol and divided into four groups:
- Neuroendocrine cancers: Atypical bronchial carcinoid, neuroendocrine carcinoma and Grade 3 NETs independent of primary site (SCLC excluded)
- Biliary tract cancers: Intrahepatic cholangiocarcinoma and gallbladder carcinoma
- Gynaecological malignancies: Ovarian clear cell carcinoma, uterine clear cell carcinoma, uterine/ovarian carcinosarcoma, uterine leiomyosarcoma and vaginal/vulva squamous cell carcinoma
- Mismatch repair protein deficient (MSI-H) cancers (excluding colorectal carcinoma).
The role of immunotherapy is being defined in more common cancer types, however because of their rarity, the efficacy of immunotherapy for these cancers is poorly defined.
This protocol provides an important opportunity to establish whether the combination of nivolumab & ipilimumab has efficacy in these cancers.
Lutetium-177 OPS-201 for Progressive Metastatic Neuroendocrine Tumours
Official Title: An International, Multicenter, Open-label Study to Evaluate Safety, Tolerability, Biodistribution, Dosimetry and Preliminary Efficacy of 177Lu-OPS201 for the Therapy of Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)
The purpose of this clinical phase I/II study is to investigate the safety and tolerability of 177Lu-OPS201 used for the treatment of patients with neuroendocrine tumours (NETs). Secondary objectives of this study are the assessment of biodistribution, dosimetry and preliminary efficacy of 177Lu-OPS201.
Contact for trial:
Theranostics Australia +618 9091 1081 or email reception@theranostics.com.au
For more information on this trial, please click here
Merkel Cell Carcinoma (MCC)
Trial Name : Avelumab in Subjects With Merkel Cell Carcinoma (JAVELIN Merkel 200)
Official Title: A Phase II, Open-Label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab (MSB0010718C) in Subjects With Merkel Cell Carcinoma
Australian Sites Recruting:
VIC: Peter MacCallum Cancer Centre – Dr Sandhu
NSW: Royal North Shore Hospital – Dr Guminski
Port Macquarie Hospital – Dr Begbie QLD: PAH, Dr Atkinson
QLD: Saint John of God (Subiaco) – Dr van Hagen
For more information on this trial please click here
Neuroendocrine Carcinoma (NEC)
Title: A Randomised Phase II Study Of nab-paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas (NABNEC Study)
Scientific Title: A phase II study to establish if carboplatin and nab-paclitaxel combination is an effective and tolerable chemotherapy treatment for grade 3 advanced gastrointestinal Neuroendocrine Carcinomas.
The primary purpose of this trial is to evaluate the safety and efficacy of carboplatin plus nab-paclitaxel in comparison with carboplatin plus etoposide chemotherapy for the treatment of gastrointestinal neuroendocrine carcinomas (NECs).
Contact person for trial:
Dr Lorraine Chantrill
Australasian Gastro-Intestinal Trials Group
Locked Bag M250
Camperdown NSW 2050
nabnec@ctc.usyd.edu.au
For more information on this trial click here.
To watch a short video see below:
