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Активно (без набиране) Фаза 1

A Phase I Study of IAG933 in Patients With Advanced Mesothelioma and Other Solid Tumors

Mesothelioma

The purpose of this study is to characterize the safety and tolerability of IAG933 in patients with mesothelioma, NF2/LATS1/LATS2 mutated tumors and tumors with functional YAP/TAZ fusions and to identify the maximum tolerated dose and/or recommended dose.

Начало: 21.10.2021 Край: 04.09.2026 Възраст: 18–120 г. Лечение

Australia, Canada, France +8 Novartis Pharmaceuticals NCT04857372

Активно (без набиране) Фаза 2/3

Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Pain

Osteoarthritis, Knee

The purpose of this study is to measure the change in pain and function with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with subcutaneous injections of placebo in participants with knee osteoarthritis pain. Study details include: * The study duration will be up to 31 weeks per participant * The treatment duration will be 6 weeks. * The visit frequency will be twice weekly during treatment. * The visit frequency will be every 4 weeks during the follow-up period.

Начало: 19.10.2021 Край: 06.01.2025 Възраст: от 18 г. Лечение

Australia, United States Paradigm Biopharmaceuticals USA (INC) NCT04809376

Активно (без набиране) Фаза 1

A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer

Neoplasms

This study is open to adults with advanced cancer (solid tumors) and people with advanced head and neck cancer. The study has 2 parts. The purpose of Part 1 of this study is to find the highest dose of a medicine called BI 765179 that people with solid tumors can tolerate when taken alone or together with a medicine called ezabenlimab. The goal of Part 2 is to find out whether BI 765179 in combination with a medicine called pembrolizumab helps people with advanced head and neck cancer. In Part 1, each participant is put into 1 of 2 groups. Participants get BI 765179 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks. In Part 2, participants are also divided into 2 groups. 1 group gets a low dose of BI 765179 in combination with pembrolizumab and the other group gets a high dose of BI 765179 in combination with pembrolizumab. Participants receive the study treatment as infusions into a vein. BI 765179, ezabenlimab, and pembrolizumab are antibodies that may help the immune system fight cancer. In this study, BI 765179 is given to people for the first time. Participants can stay in the study up to 2 years if they benefit from treatment and can tolerate it. The doctors regularly check the participants' health and note any health problems that could have been caused by the study treatment.

Начало: 18.10.2021 Край: 17.02.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +12 Boehringer Ingelheim NCT04958239

Активно (без набиране) Фаза 3

Study of Vimseltinib for Tenosynovial Giant Cell Tumor

Tenosynovial Giant Cell Tumor Pigmented Villonodular Synovitis Giant Cell Tumor of Tendon Sheath Tenosynovial Giant Cell Tumor, Diffuse +1

This is a multicenter Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumor (TGCT) in cases where surgical removal of the tumor is not an option. The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either vimseltinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Participants assigned to placebo in Part 1 will have the option to receive vimseltinib for Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label vimseltinib.

Начало: 14.10.2021 Край: 01.07.2028 Възраст: от 18 г. Лечение

Australia, Canada, France +10 Deciphera Pharmaceuticals, LLC NCT05059262

Активно (без набиране) Фаза 1

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab

Non-Small Cell Lung Cancer Advanced Solid Tumors Gastroesophageal Adenocarcinoma Colorectal Cancer

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose and combination with bevacizumab. Approximately 500 adult participants with NSCLC, gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) and colorectal cancer (CRC) or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 85-95 sites in the Dose Expansion phase worldwide. Dose escalation arms, participants will receive intravenous (IV) escalating doses of ABBV-400 monotherapy. Dose expansion arms, participants in the following advanced solid tumor indications: non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) \[Part 2i\] or mutated EGFR-expression (mutEGFR NSCLC) \[Part 2ii\], squamous NSCLC \[Part 2iii\], GEA \[Part 3\] will receive intravenous (IV) ABBV-400 monotherapy, participants CRC will receive IV ABBV-400 monotherapy in expansion \[Part 4\], participants MET amplification will receive IV ABBV-400 monotherapy in expansion \[Part 5\], participants MET mutation will receive IV ABBV-400 monotherapy in expansion \[Part 6\], participants CRC safety lead in will receive escalating doses of IV ABBV-400 in combination with IV bevacizumab \[Part 7a\], and participants CRC dose optimization in will the low or high dose of IV ABBV-400 determined in Part 7a in combination with IV bevacizumab or oral trifluridine/tipiracil (TAS-102) tablets \[Part 7b\]. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Начало: 13.10.2021 Край: 01.11.2027 Възраст: от 18 г. Лечение

Australia, France, Israel +7 AbbVie NCT05029882

Активно (без набиране) Фаза 2

A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.

Начало: 11.10.2021 Край: 22.04.2029 Възраст: 18–70 г. Лечение

Argentina, Australia, Brazil +16 Bristol-Myers Squibb NCT04895696

Активно (без набиране) Фаза 2

A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

Ovarian Cancer

This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.

Начало: 07.10.2021 Край: 30.05.2028 Възраст: от 18 г. Лечение

Australia, Canada, Czechia +10 Hoffmann-La Roche NCT04931342

Активно (без набиране) Фаза 3

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive

The study is designed to compare the efficacy of asciminib 80 mg QD versus Investigator selected Tyrosine Kinase Inhibitor (TKI) for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP. The Investigator selected TKI will be one of the following treatment options for first-line treatment of CML-CP - imatinib 400 mg QD or nilotinib 300 mg BID or dasatinib 100 mg QD or bosutinib 400 mg QD. This study has three periods: 1. Treatment period for all randomized participants, 2. Optional Treatment-Free Remission (TFR) period only for participants meeting TFR eligibility criteria and 3. Treatment Re-Initiation (TRI) period only for participants who relapsed after TFR attempt.

Начало: 06.10.2021 Край: 18.01.2031 Възраст: 18–100 г. Лечение

Australia, Belgium, Bulgaria +23 Novartis Pharmaceuticals NCT04971226

Активно (без набиране) Фаза 3

Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma

Primary Mediastinal Large B-Cell Lymphoma

This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.

Начало: 05.10.2021 Край: 31.12.2026 Възраст: от 2 г. Лечение

Australia, Canada, Puerto Rico +1 National Cancer Institute (NCI) NCT04759586

Активно (без набиране) Фаза 3

Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis

Multiple Sclerosis (MS)

Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis

Начало: 05.10.2021 Край: 06.03.2031 Възраст: 10–17 г. Лечение

Argentina, Australia, Belgium +20 Novartis Pharmaceuticals NCT04926818

Активно (без набиране) Фаза 3

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

Breast Neoplasms Neoplasm Metastasis

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.

Начало: 04.10.2021 Край: 01.08.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +18 Eli Lilly and Company NCT04975308

Активно (без набиране) Фаза 2

Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis

Osteoarthritis, Knee

Evaluation of safety, tolerability and efficacy of a single intra-articular (IA) injection of PTP-001, an allogeneic placental tissue particulate, in individuals with knee osteoarthritis (OA).

Начало: 30.09.2021 Край: 30.11.2022 Възраст: 40–80 г. Лечение

Australia, Canada, Denmark Bioventus LLC NCT05100225

Активно (без набиране) Фаза 3

Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing

Advanced Malignancies NSCLC Ovarian Cancer Urothelial Cancer +1

This Master Protocol for Avelumab Continuation Sub-Studies is to provide continued treatment access, safety follow-up, and when applicable, overall survival follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer-sponsored Avelumab parent studies.

Начало: 29.09.2021 Край: 30.09.2026 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +16 Pfizer NCT05059522

Активно (без набиране) Фаза 3

Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent

Arthritis, Psoriatic

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.

Начало: 28.09.2021 Край: 16.07.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Bulgaria +11 Janssen Research & Development, LLC NCT04936308

Активно (без набиране) Фаза 2

Study of INBRX-109 in Conventional Chondrosarcoma

Conventional Chondrosarcoma

Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.

Начало: 23.09.2021 Край: 01.12.2026 Възраст: 18–85 г. Лечение

Australia, France, Germany +6 Inhibrx Biosciences, Inc NCT04950075

Активно (без набиране) Фаза 3

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.

Начало: 23.09.2021 Край: 01.10.2027 Възраст: от 18 г. Лечение

Australia, Brazil, Bulgaria +15 Loxo Oncology, Inc. NCT05023980

Активно (без набиране) Фаза 1

A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

Multiple Myeloma

The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.

Начало: 22.09.2021 Край: 07.04.2027 Възраст: от 18 г. Лечение

Australia, Belgium, France +3 Janssen Research & Development, LLC NCT05050097

Активно (без набиране) Фаза 3

A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

Начало: 20.09.2021 Край: 01.10.2027 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +18 Loxo Oncology, Inc. NCT04965493

Активно (без набиране)

A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera SCS System with HomeStream Remote Management

Chronic Low-back Pain Chronic Leg Pain

The BENEFIT-03 Clinical Study is a first in human, prospective, multi-center, single-arm, interventional feasibility study to be conducted in Australia. The purpose of the BENEFIT-03 study is to collect initial safety and effectiveness data on the BIOTRONIK Prosper SCS (Spinal Cord Stimulation) System with HomeStream Remote Management. Enrolled participants will complete a SCS trial period per the standard of care utilizing the BIOTRONIK Resilience percutaneous SCS trial leads and the BIOTRONIK Prospera External Pulse Generator (EPG). Following a successful trial period, participants will be implanted with a permanent BIOTRONIK Prospera Implantable Pulse Generator (IPG). Implanted participants will be followed for 24 months post-implant with in-office visits and remote management visits.

Начало: 20.09.2021 Край: 01.01.2027 Възраст: 18–79 г. Лечение

Australia Biotronik, Inc. NCT04683718

Активно (без набиране) Фаза 3

Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)

HIV-1 Infection

The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (100mg) and islatravir (0.75mg) \[DOR/ISL 100 mg/0.75 mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.

Начало: 15.09.2021 Край: 29.05.2029 Възраст: от 18 г. Лечение

Australia, Canada, Chile +13 Merck Sharp & Dohme LLC NCT04776252

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