Editing Trials (Helsinki University Hospital Comprehensive Cancer Center)

'''NCTID''': NCT04657991
 '''Title''': A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma
 '''Study Summary''': The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that:  * is advanced or metastatic (spread to other parts of the body); * has a certain type of abnormal gene called "BRAF"; and * has not received prior treatment.  All participants in this study will receive pembrolizumab at the study clinic once every 3 weeks as an intravenous (IV) infusion (given directly into a vein). In addition, half of the participants will take encorafenib and binimetinib orally (by mouth) at home every day.  Participants may receive pembrolizumab for up to two years. Those participants taking encorafenib and binimetinib can continue until their melanoma is no longer responding. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
 '''Sponsor''': Pfizer
 '''Intervention''': Encorafenib
 '''Start Date''': 2021-01-15
 '''Last Updated''': 2023-11-07
 '''Number of Patients''': 624
 '''Recruitment Status''': RECRUITING
 '''Condition''': Melanoma
'''NCTID''': NCT05813808
 '''Title''': Low-dose Computer Tomography in Follow-up of Soft Tissue Sarcomas
 '''Study Summary''': The goal of this interventional study is to compare sensitivity of regular chest x-ray to ultra-low-dose computed tomography to find pulmonary relapse in follow-up of soft tissue sarcoma. The main question\[s\] it aims to answer are:  * Is ultra-low-dose computed tomography more sensitive than regular chest x-ray to find pulmonary relapse? * Does ultra-low-dose computed tomography detect the most fast-growing pulmonary metastases earlier than regular chest x-ray?  Participants will have seven ultra-low-dose computed tomography imagings in addition to simultaneous routine protocol of chest x-rays. Participants therefore work as their own controls.
 '''Sponsor''': Helsinki University Central Hospital
 '''Intervention''': ultra-low-dose computed tomography
 '''Start Date''': 2017-06-01
 '''Last Updated''': 2023-04-19
 '''Number of Patients''': 50
 '''Recruitment Status''': COMPLETED
 '''Condition''': Sarcoma,Soft Tissue
'''NCTID''': NCT04821622
 '''Title''': Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC
 '''Study Summary''': The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.
 '''Sponsor''': Pfizer
 '''Intervention''': talazoparib plus enzalutamide
 '''Start Date''': 2021-05-12
 '''Last Updated''': 2023-11-22
 '''Number of Patients''': 599
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING
 '''Condition''': Prostate Cancer
'''NCTID''': NCT04332822
 '''Title''': A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma
 '''Study Summary''': This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy and Switzerland, in elderly patients with untreated diffuse large B-cell lymphoma. Elderly is defined as either ≥80 years of age, or ≥75 years and frail, according to a simplified Comprehensive Geriatric Assessment. Patients will be randomized 1:1 to either the standard treatment for this population, R-miniCHOP, or an experimental regimen, R-pola-miniCHP, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin. The duration of the screening period is up to 4 weeks. The duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment. Start of enrollment is planned in Q1 2020, and the last visit of the last patient included (end of trial) is estimated in Q1 2026.
 '''Sponsor''': Nordic Lymphoma Group
 '''Intervention''': R-pola-mini-CHP
 '''Start Date''': 2020-08-19
 '''Last Updated''': 2021-07-09
 '''Number of Patients''': 200
 '''Recruitment Status''': RECRUITING
 '''Condition''': DLBCL
'''NCTID''': NCT05214183
 '''Title''': Acalabrutinib and Rituximab in Elderly Patients With Untreated Mantle Cell Lymphoma
 '''Study Summary''': This is a phase II trial, with the aim of developing a chemotherapy-free regimen for untreated patients with mantle cell lymphoma (MCL).  Acalabrutinib (ACP-196) is a next generation bruton tyrosine kinase (BTK) inhibitor, more selective than ibrutinib, and without in vitro antagonism of anti-CD20 directed immunotherapies, indicating that its combination with rituximab may be more active than the combination of ibrutinib and rituximab.  In this trial proposal, we will also assess the activity of this combination in comparison to a historical control of ibrutinib + rituximab, consisting of the experimental arm of ibrutinib + rituximab in the randomized ENRICH trial (EudraCT number 2015-000832-13), and data from our previous trial with R-bendamustine-lenalidomide (NLG-MCL4).  The duration of treatment will be a minimum of 12 months. Patients in molecular remission in blood and bone marrow and in complete remission according to CT, will then stop acalabrutinib, but continue on rituximab for a maximum of 36 months. Patients that are minimal residual disease positive (MRD+) will be evaluated again every 6 months and continue on acalabrutinib for a maximum of 36 months.  Patients without a molecular marker, that cannot be followed with MRD, will stop treatment if in CR with PET at 12 months, and be followed by PET-CT every 6 months for a maximum of 36 months.  Patients who convert back to MRD positive after stopping acalabrutinib are reinstalled on acalabrutinib until progression.  Patients with TP53 aberrations and/or blastoid histology, will monitor MRD but continue with treatment until progression regardless of MRD results.  A planned interim analysis will be performed when 40 patients have undergone response assessment after 6 months, for futility and efficacy.  If less than 16 of 40 patients obtain a CR, the trial will be stopped due to futility.
 '''Sponsor''': Nordic Lymphoma Group
 '''Intervention''': Acalabrutinib-rituximab in patients with untreated mantle cell lymphoma
 '''Start Date''': 2021-12-15
 '''Last Updated''': 2022-02-14
 '''Number of Patients''': 80
 '''Recruitment Status''': RECRUITING
 '''Condition''': MCL
'''NCTID''': NCT05514054
 '''Title''': A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
 '''Study Summary''': The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.
 '''Sponsor''': Eli Lilly and Company
 '''Intervention''': Imlunestrant
 '''Start Date''': 2022-10-04
 '''Last Updated''': 2023-10-24
 '''Number of Patients''': 6000
 '''Recruitment Status''': RECRUITING
 '''Condition''': Breast Neoplasms
'''NCTID''': NCT01796171
 '''Title''': A Phase I/II Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma
 '''Study Summary''': This study is a phase I/II open-label study in patients with relapsed indolent NHL (Part A) or relapsed/refractory FL (Part B). Part A of the study assessed the safety and preliminary efficacy. This seamless design study now has four parts: 1) Part A, Ph I - dose escalation, 2) Part A, Ph II - dose expansion, 3) Part B, Ph II randomized - refinement of dose, and 4) Part B and C, Phase II, single-arm. As of August 7, 2020, patients are enrolling in the fourth part of the study.
 '''Sponsor''': Nordic Nanovector
 '''Intervention''': Betalutin
 '''Start Date''': 2012-12
 '''Last Updated''': 2022-09-14
 '''Number of Patients''': 191
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING
 '''Condition''': Non-Hodgkin Lymphoma
'''NCTID''': NCT05317416
 '''Title''': Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant
 '''Study Summary''': The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years
 '''Sponsor''': Pfizer
 '''Intervention''': Elranatamab
 '''Start Date''': 2022-03-25
 '''Last Updated''': 2023-11-03
 '''Number of Patients''': 760
 '''Recruitment Status''': RECRUITING
 '''Condition''': Multiple Myeloma
'''NCTID''': NCT05159245
 '''Title''': The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs
 '''Study Summary''': This is a prospective non-randomized national clinical phase 2 trial that aims to determine the efficacy and toxicity of targeted anticancer drugs or combinations that are approved or under review by EMA, FDA or PMDA and are used for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic, RNA-molecular or protein expression test.
 '''Sponsor''': Helsinki University Central Hospital
 '''Intervention''': Alectinib
 '''Start Date''': 2021-12-10
 '''Last Updated''': 2023-09-22
 '''Number of Patients''': 250
 '''Recruitment Status''': RECRUITING
 '''Condition''': Advanced Cancer
'''NCTID''': NCT03850795
 '''Title''': HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
 '''Study Summary''': This study is a multinational Phase 3, randomized, double-blind, non-inferiority, efficacy and safety study of oral HC-1119 (80 mg/day) versus enzalutamide (160 mg/day) in asymptomatic or mildly symptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC).  The following assessment of prostate cancer status will be collected during the course of the trial: soft tissue disease on computed tomography (CT) scan or on magnetic resonance imaging (MRI), bone disease on radionuclide bone scans, FACT-P and EQ-5D, Brief Fatigue Inventory, and PSA.  Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs and physical examinations, safety laboratory evaluations, and 12-lead electrocardiograms (ECGs). Blood samples for population pharmacokinetics for HC-1119 and enzalutamide and related metabolites will be collected.
 '''Sponsor''': Hinova Pharmaceuticals USA, Inc.
 '''Intervention''': HC-1119
 '''Start Date''': 2021-03-15
 '''Last Updated''': 2023-09-22
 '''Number of Patients''': 104
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING
 '''Condition''': Prostate Cancer Metastatic
'''NCTID''': NCT03315546
 '''Title''': Radiotherapy Delivery in Deep Inspiration for Pediatric Patients
 '''Study Summary''': TEDDI is a non-randomised phase II trial in Scandinavia. All pediatric patients, referred for radiotherapy in the thorax or abdomen and irrespective of diagnosis, are eligible.  Deep inspiration breath-hold (DIBH) is a simple radiotherapy technique, which could have a dramatic impact on the risk of late effects in children. In DIBH, the radiotherapy is delivered while the patient holds his/her breath (4-6 sequential breath-holds). The anatomy is changed and imaging artifacts from respiratory movement are diminished. DIBH is widely used in adult patients with breast cancer and mediastinal lymphoma to minimize the risk of radiation-induced late effects due to a reduced dose to the healthy organs. Also, the technique is simple and cost-efficient.  For pediatric patients, the investigators aim to:  * Estimate the dosimetric benefit of radiotherapy using DIBH compared to free-breathing * Establish the compliance of DIBH * Determine if DIBH is an accurate and reproducible strategy * Optimize treatment planning considering the risk from loss of tumour control as well as the risk of late effects.
 '''Sponsor''': Rigshospitalet, Denmark
 '''Intervention''': radiotherapy delivery in deep-inspiration
 '''Start Date''': 2017-01-01
 '''Last Updated''': 2020-10-09
 '''Number of Patients''': 25
 '''Recruitment Status''': RECRUITING
 '''Condition''': Pediatric Cancer
'''NCTID''': NCT05173987
 '''Title''': Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)
 '''Study Summary''': The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy.  The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).
 '''Sponsor''': Merck Sharp & Dohme LLC
 '''Intervention''': pembrolizumab
 '''Start Date''': 2022-02-03
 '''Last Updated''': 2023-11-09
 '''Number of Patients''': 280
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING
 '''Condition''': Endometrial Neoplasms
'''NCTID''': NCT02678299
 '''Title''': Phase 1/2 Study of the Combination of Pixantrone, Etoposide, Bendamustine and, in CD20 Positive Tumors, Rituximab in Patients With Relapsed Aggressive Non-Hodgkin Lymphomas of B- or T-cell Phenotype - the P[R]EBEN Study
 '''Study Summary''': This is a phase 1/2 open label study to assess the safety and efficacy of pixantrone in combination with bendamustine, etoposide and , for CD20 positive B-cell lymphomas, rituximab (P\[R\]EBEN), in patients with relapsed aNHL of B- or T-cell phenotype.
 '''Sponsor''': University of Aarhus
 '''Intervention''': PREBEN
 '''Start Date''': 2016-02
 '''Last Updated''': 2022-08-04
 '''Number of Patients''': 60
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING
 '''Condition''': Malignant Lymphoma
'''NCTID''': NCT06044623
 '''Title''': Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients
 '''Study Summary''': IMPORTANT study is a multicenter, open-label, prospective, randomized-controlled, non-inferiority trial with a pragmatic approach involving older patients (≥ 70 years old) with advanced hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer, not amenable for curative treatment and without prior therapy for advanced disease, who are suitable to receive CDK 4/6-inhibitors plus endocrine therapy as first line therapy. The study implements two approaches with high level of evidence, namely the use of comprehensive geriatric assessment (CGA) approach in treatment decision making and the use of CDK 4/6-inhibitors as the initial treatment of choice, to investigate whether a common clinical practice (starting dose reduction of CDK 4/6-inhibitors in older patients) with evidence of low certainty can be standardized using a more individualized-based approach.  On the basis of baseline CGA assessment, patients will either receive full dose of CDK 4/6-inhibitors plus endocrine therapy (if patients are fit according to CGA) or be randomized to full dose vs. reduced initial dose of CDK 4/6-inhibitors (if vulnerable or frail according to CGA). The study hypothesis is that adjusting the dose according to vulnerability will allow patients to tolerate treatment better without jeopardizing the treatment efficacy.  This project has received funding from the European Union's HORIZON 2022 research and innovation actions supporting the implementation of the Mission on Cancer under grant agreement No 101104589.
 '''Sponsor''': Region Örebro County
 '''Intervention''': CDK 4/6 inhibitors
 '''Start Date''': 2023-11
 '''Last Updated''': 2023-10-27
 '''Number of Patients''': 495
 '''Recruitment Status''': NOT_YET_RECRUITING
 '''Condition''': Metastatic Breast Cancer
'''NCTID''': NCT05239728
 '''Title''': A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)
 '''Study Summary''': The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy.  The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS).
 '''Sponsor''': Merck Sharp & Dohme LLC
 '''Intervention''': Belzutifan
 '''Start Date''': 2022-03-15
 '''Last Updated''': 2023-11-18
 '''Number of Patients''': 1800
 '''Recruitment Status''': RECRUITING
 '''Condition''': Carcinoma, Renal Cell
'''NCTID''': NCT05020236
 '''Title''': MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
 '''Study Summary''': The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Part 3 of the study will evaluate an alternative dosing schedule of elranatamab in combination with daratumumab. Participants in all parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.
 '''Sponsor''': Pfizer
 '''Intervention''': Elranatamab
 '''Start Date''': 2021-10-04
 '''Last Updated''': 2023-08-24
 '''Number of Patients''': 854
 '''Recruitment Status''': RECRUITING
 '''Condition''': Multiple Myeloma
'''NCTID''': NCT02993523
 '''Title''': A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy
 '''Study Summary''': Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the participant has, and the age of the participant when diagnosed.  Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to azacitidine works better than azacitidine on its own.  This is a Phase 3, randomized, double-blind (treatment is unknown to participants and doctors), placebo controlled study in patients with AML who are \>= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for standard induction therapy (usual starting treatment). AbbVie is funding this study which will take place at approximately 180 hospitals globally and enroll approximately 400 participants.  In this study, 2/3 of participants will receive venetoclax every day with azacitidine and the remaining 1/3 will receive placebo (dummy) tablets with azacitidine.  Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.
 '''Sponsor''': AbbVie
 '''Intervention''': Azacitidine
 '''Start Date''': 2017-02-02
 '''Last Updated''': 2023-07-03
 '''Number of Patients''': 443
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING
 '''Condition''': Acute Myeloid Leukemia (AML)
'''NCTID''': NCT04603001
 '''Title''': Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations
 '''Study Summary''': This is an open-label, multi-center Phase 1 study of LY3410738, an oral, covalent isocitrate dehydrogenase (IDH) inhibitor, in patients with IDH1 and/or IDH2-mutant advanced hematologic malignancies who may have received standard therapy
 '''Sponsor''': Eli Lilly and Company
 '''Intervention''': LY3410738
 '''Start Date''': 2020-12-01
 '''Last Updated''': 2023-09-01
 '''Number of Patients''': 260
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING
 '''Condition''': Acute Myeloid Leukemia (AML)
'''NCTID''': NCT03505944
 '''Title''': Venetoclax, Lenalidomide and Rituximab in Patients With Relapsed/Refractory Mantle Cell Lymphoma
 '''Study Summary''': Phase I/II trial, with the aim of evaluating the efficacy of venetoclax to the backbone of rituximab-lenalidomide in patients with relapsed/refractory MCL.
 '''Sponsor''': Nordic Lymphoma Group
 '''Intervention''': Venetoclax
 '''Start Date''': 2018-07-01
 '''Last Updated''': 2021-10-13
 '''Number of Patients''': 59
 '''Recruitment Status''': UNKNOWN
 '''Condition''': Relapsed Non Hodgkin Lymphoma