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Активно (без набиране) Фаза 2

Combination Immunotherapy in Rare Cancers Under InvesTigation

Advanced Biliary Tract Cancer Neuroendocrine Tumors Female Reproductive System Neoplasm MSI-H Solid Malignant Tumor

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: 1. Neuroendocrine cancers: Atypical bronchial carcinoid, neuroendocrine carcinoma and Grade 3 NETs independent of primary site (SCLC excluded) 2. Biliary tract cancers: Intrahepatic cholangiocarcinoma and gallbladder carcinoma 3. Gynaecological malignancies: Ovarian clear cell carcinoma, uterine clear cell carcinoma, uterine/ovarian carcinosarcoma, uterine leiomyosarcoma and vaginal/vulva squamous cell carcinoma 4. 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.

Начало: 03.08.2021 Край: 01.03.2027 Възраст: от 18 г. Лечение

Australia, New Zealand Olivia Newton-John Cancer Research Institute NCT04969887

Активно (без набиране)

PMCF Study in Patients With Acute or Chronic Aortic Dissection or Aortic Aneurysm Treated With E-vita OPEN NEO

Aortic Dissection Aortic Aneurysm

The NEOS-APAC post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of E-vita OPEN NEO in the treatment of aneurysm or dissection in the ascending aorta, aortic arch and descending thoracic aorta.

Начало: 01.08.2021 Край: 31.03.2027 Възраст: 18–75 г.

Australia, Hong Kong, Malaysia +3 JOTEC GmbH NCT04986709

Активно (без набиране) Фаза 1/2

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM

Multiple Myeloma

The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with isatuximab, and to establish the recommended Phase 2 dose (RP2D) for the combination treatment to explore in the cohort expansion (CE) phase in participants with RRMM. This study is a sub study of the Master protocol (NCT04126200).

Начало: 29.07.2021 Край: 11.03.2027 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +8 GlaxoSmithKline NCT07217184

Активно (без набиране) Фаза 1

A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma

This Phase Ib, multicenter, open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cevostamab monotherapy, cevostamab plus pomalidomide and dexamethasone (Pd) or cevostamab plus daratumumab and dexamethasone (Dd) which will be administered to participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.

Начало: 26.07.2021 Край: 10.12.2029 Възраст: от 18 г. Лечение

Australia, Canada, Czechia +10 Genentech, Inc. NCT04910568

Активно (без набиране) Фаза 3

Phase 3 Study to Evaluate Intravenous Trappsol(R) Cyclo(TM) in Pediatric and Adult Patients With Niemann-Pick Disease Type C1

Niemann-Pick Disease, Type C1

A prospective, randomized, double-blind, placebo controlled, multi-center therapeutic study for patients age 3 and older with confirmed diagnosis of Niemann Pick disease type C1 (NPC1). The objective of this study is to evaluate the safety, tolerability and efficacy of 2000 mg/kg dose of Trappsol Cyclo (hydroxypropyl betacyclodextrin) administered intravenously compared to standard of care. An open-label sub-study in countries following European Medicines Agency (EMA) guidance will enroll asymptomatic or symptomatic patients from infancy up to age 3 to evaluate safety in that population.

Начало: 20.07.2021 Край: 01.06.2026 Възраст: от 3 г. Лечение

Argentina, Australia, Brazil +10 Cyclo Therapeutics, Inc. NCT04860960

Активно (без набиране) Фаза 3

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

Psoriatic Arthritis

The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy information.

Начало: 15.07.2021 Край: 12.11.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +15 Bristol-Myers Squibb NCT04908189

Активно (без набиране) Фаза 3

A Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome)

Neovascular Age-related Macular Degeneration (nAMD)

Study WR42221 is a Phase IIIb, global, multicenter, randomized, visual assessor-masked study designed to assess the efficacy, safety, and pharmacokinetics of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 36 weeks (Q36W) compared with every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD).

Начало: 14.07.2021 Край: 07.01.2027 Възраст: от 50 г. Лечение

Argentina, Australia, Belgium +12 Hoffmann-La Roche NCT04657289

Активно (без набиране)

Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

Symptomatic Severe Aortic Stenosis

Evaluation of TAVR using the NAVITOR valve in a Global Investigation.

Начало: 13.07.2021 Край: 28.02.2036 Възраст: 18–100 г. Лечение

Australia, Denmark, France +6 Abbott Medical Devices NCT04788888

Активно (без набиране) Фаза 2

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

Lupus Erythematosus, Discoid Lupus Erythematosus, Subacute Cutaneous

The purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will also assess if deucravacitinib is biologically active and potentially effective in the treatment of participants with moderate to severe DLE/SCLE with or without systemic lupus erythematosus (SLE) that is not well controlled with standard of care therapy.

Начало: 12.07.2021 Край: 28.02.2028 Възраст: 18–75 г. Лечение

Argentina, Australia, France +5 Bristol-Myers Squibb NCT04857034

Активно (без набиране) Фаза 3

Efficacy Study of 4CMenB (Bexsero®) to Prevent Gonorrhoea Infection in Gay and Bisexual Men

Neisseria Gonorrheae Infection

This is a Phase 3, double-blinded, randomised placebo-controlled, multi-centred trial evaluating the efficacy of the four-component meningococcal B vaccine, 4CMenB (Bexsero®), in the prevention of Neisseria gonorrhoeae infection.The targeted population is 18-50 years-old men (cis and trans), trans women and non-binary people who have sex with men (hereafter referred to as Gay Bisexual Men+ \[GBM+\], either HIV-negative and taking pre-exposure prophylaxis \[PrEP\], or HIV-positive with undetectable viral load \350 cells/cmm) who have high N. gonorrhoeae incidence and are recommended by Australian guidelines to have regular, comprehensive sexual health screening. 730 participants will be enrolled and randomised 1:1 and stratified by clinical sites to receive two doses of 4CMenB vaccine or a matching placebo at 0 and 3 months by intramuscular injection. Recruitment is for 12 months and all participants will be follow-up 3-monthly for a period of 2 years. The trial aims to evaluate the efficacy of 4CMenB in the prevention of N. gonorrhoeae infection.

Начало: 08.07.2021 Край: 30.10.2025 Възраст: 18–50 г. Превенция

Australia Kirby Institute NCT04415424

Активно (без набиране) Фаза 3

Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma

Malignant Melanoma Stage III

This is an international (Australia, Europe, and USA) open-label two-arm randomized phase 3 trial including 420 stage III (≤3 resectable in-transit metastases allowed) cutaneous or unknown primary melanoma patients. Patients will be randomized 1:1 to receive either 2 cycles of neoadjuvant ipilimumab 80 mg + nivolumab 240 mg every 3 weeks followed by a total lymph node dissection (TLND) and, if applicable, resection of in-transit metastases (arm A) versus standard upfront TLND +/- resection of in-transit metastases followed by 12 cycles adjuvant nivolumab 480 mg every 4 weeks (arm B). Patients with a pathologic partial or non-response in arm A will also receive adjuvant nivolumab 480 mg every 4 weeks for 46 weeks (11 cycles). In case of BRAF V600E/K mutation-positivity, patients from arm A with a pathologic partial or non-response (\>10% viable tumor) will be treated with adjuvant dabrafenib plus trametinib for 46 weeks. Patients will be treated in the study in both arms until melanoma progression to irresectable stage III or stage IV disease, disease recurrence, unacceptable toxicity, subject withdrawal of consent or until end of study treatment. An interim analysis will be performed after 60 events have occurred. The data safety monitory board (DSMB) will be ad hoc consulted when unexpected toxicities are reported. Patients will be followed by 12 weekly CT scans until end of year 3 and then until year 5 according to the institute's standards.

Начало: 08.07.2021 Край: 19.12.2028 Възраст: от 16 г. Лечение

Australia, Netherlands, United States The Netherlands Cancer Institute NCT04949113

Активно (без набиране)

The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing

DCIS

This is a prospective cohort study for patients diagnosed with ductal carcinoma in situ (DCIS) of the breast. The primary objective of the study is to create a de-identified database of patients, test results, treatment decisions and outcomes that can be queried to determine the utility of the DCISionRT™ test in the diagnosis and treatment of ductal carcinoma in situ of the breast.

Начало: 02.07.2021 Край: 01.12.2035 Възраст: от 26 г.

Australia PreludeDx NCT04916808

Активно (без набиране) Фаза 1

Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)

Neoplasm Metastasis Non-Small Cell Lung Cancer

The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene. The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink. In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day. The participants are in the study for as long as they benefit from and can tolerate treatment. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.

Начало: 02.07.2021 Край: 30.08.2028 Възраст: от 18 г. Лечение

Australia, Belgium, China +14 Boehringer Ingelheim NCT04886804

Активно (без набиране) Фаза 1/2

A Multicentre, Parallel Arm, Open-label Trial of Frontline R-CHOP/Pola-RCHP and Glofitamab in Younger, Higher Risk Patients With Diffuse Large B Cell Lymphoma (DLBCL)

Diffuse Large B Cell Lymphoma High-grade B-cell Lymphoma

This is an open label, multi-centre, phase Ib/II, parallel arm study evaluating the safety and tolerability of glofitamab in addition to backbone chemotherapy consisting of R-CHOP or polatuzumab vedotin-RCHP for younger patients with higher-risk Diffuse Large B-cell Lymphoma or High Grade B-Cell Lymphoma.

Начало: 29.06.2021 Край: 01.07.2025 Възраст: 18–65 г. Лечение

Australia Peter MacCallum Cancer Centre, Australia NCT04914741

Активно (без набиране)

Advanced Techniques for Single-fraction Palliative Radiotherapy Versus ASPIRE-single

Palliative Radiotherapy Radiotherapy, Intensity-Modulated

One third of patients treated in the radiation oncology departments are treated with palliative intent. These patients can be unwell due to their advanced disease and suffering from pain and other symptoms related to metastases. Radiation therapy (RT) has an important role in the symptomatic relief and improvement in the quality of life (QoL) for these patients.The aim of the study is to determine if escalated single fraction palliative radiotherapy using intensity-modulated techniques results in a prolonged duration of benefit for patients otherwise suitable for standard single fraction radiotherapy.

Начало: 29.06.2021 Край: 31.12.2026 Лечение

Australia Royal North Shore Hospital NCT04658537

Активно (без набиране) Фаза 3

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

Pre-Exposure Prophylaxis of HIV Infection

The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV-1 infection. The primary objective of this study is to evaluate the efficacy of LEN for HIV-1 PrEP in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth at risk of HIV-1 infection.

Начало: 28.06.2021 Край: 01.08.2028 Възраст: от 16 г. Превенция

Argentina, Brazil, Mexico +5 Gilead Sciences NCT04925752

Активно (без набиране) Фаза 3

Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

Neoplasms, Breast

This study will assess the efficacy and safety of Niraparib in participants with either tumor mutation in the BRCA gene (tBRCAmut) HER2- breast cancer (Independent of hormone receptor \[HR\] status, including HR positive \[+\] and TNBC) or tumor BRCA wild type (tBRCAwt) TNBC with molecular disease based on the presence of circulating tumor Deoxyribonucleic acid (ctDNA) following surgery or completion of adjuvant therapy.

Начало: 28.06.2021 Край: 31.12.2025 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +22 GlaxoSmithKline NCT04915755

Активно (без набиране)

Determining the Effectiveness of Working Out Dads to Reduce Mental Health Difficulties in Fathers of Young Children

Mental Health Issue

This is an individually randomised trial, where Working Out Dads (WOD) will be delivered as a group intervention. Participants will be randomised to one of two groups: either WOD or usual care.The trial aims to test the effectiveness and cost-effectiveness of WOD, a 6-week week group-based peer support intervention, in reducing fathers' mental health difficulties in early parenthood.

Начало: 24.06.2021 Край: 30.11.2026 Възраст: от 18 г. Лечение

Australia Murdoch Childrens Research Institute NCT04813042

Активно (без набиране) Фаза 3

Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)

Advanced Colorectal Cancer Metastatic Colorectal Cancer

Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.

Начало: 24.06.2021 Край: 30.01.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +26 Mirati Therapeutics Inc. NCT04793958

Активно (без набиране) Фаза 3

A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer

Breast Cancer

This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).

Начало: 22.06.2021 Край: 26.05.2026 Възраст: 18–130 г. Лечение

Australia, Belgium, Canada +12 AstraZeneca NCT04739761

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