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Clinical Trials

ivo.es Research Clinical Trials

What is a clinical trial?

A study to determine whether a new treatment, drug, device, or diagnostic or therapeutic technique will help prevent, detect or treat a disease by being applied to humans.

Clinical trials also help to find out whether or not these new treatments are safe and whether they are better than treatments that are currently available.

The entire process for the commercialisation of a new medicine takes about 10 years. During that time, the number of subjects/trials gradually increases.

Phases of a clinical trial

The development of new drugs goes through a process called clinical trials: research aimed at finding new drugs for the prevention and treatment of diseases, including cancer, as well as new diagnostic and surgical techniques.

After the pre-clinical phase (in order to obtain new chemical substances and experimenting with animals in the laboratory) and before marketing the drug, researchers test its efficacy, check its safety and analyse its results in comparison with those of previously available drugs.

Trials that compare the treatment under investigation with the established therapy are called “double-blind”. Neither the participants nor the researchers know who is receiving which treatment. This ensures objectivity.

Tolerance and safety

This is the first step in human drug research. It is usually done on healthy volunteers, or patients when it comes to anti-cancer drugs, i.e. drugs that prevent or slow down cell division and are used in the treatment of cancer. They give us preliminary information on the safety and tolerability of these drugs.

Comparison of efficacy and safety with standard treatments

The sample size is extended to thousands of patients. Numerous researchers are involved to assess the efficacy of the new medicine. Adverse effects are analysed. The new drug is compared with standard treatment to confirm evidence of efficacy. This phase takes place prior to the authorisation and marketing of a drug.

Marketing and new indications

The drug is already on the market. Testing is carried out to monitor the long-term safety of the medicine and to analyse the results on the disease itself. New indications or dosages of the product are studied and compared with other known medicines.

Clinical trials carried out by the IVO

Description of clinical trials by speciality and tumour.

Surgery

Title: Phase IV multicentric clinical trial to evaluate the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) with mytomicin-C after complete surgical cytoreduction in patients with colon cancer peritoneal metastases. Code: GECOP-MMC 

Oncology

Title: The BURAN study of buparlisib (AN2025) in combination with paclitaxel compared to paclitaxel alone, in patients with recurrent or metastatic head and neck squamous cell carcinoma. Code: AN2025H0301_ BURAN

Title: A phase III pivotal study of NBTXR3 activated by investigator’s choice of radiotherapy alone or radiotherapy in combination with cetuximab for platinum-based chemotherapy-ineligible elderly patients with locally advanced head and neck squamous cell carcinoma. Code: NANORAY-312 

Title: A phase 1, open-label, multicentre, dose-escalation study of ck-301 administered intravenously as a single agent to subjects with advanced cancers. Code: CK-301-101

Title: A randomized, placebo-controlled, double-blind study of adjuvant cemiplimab versus placebo after surgery and radiation therapy in patients with high risk cutaneous squamous cell carcinoma. Code: R2810-ONC-1788

Title: Phase II trial of Pembrolizumab and Olaparib in homologous-recombination deficient (HRD) advanced colorectal cancer (CRC). Code: PEMBROLA

Title: A randomized, open label, phase II trial of Anti-PD1, TSR-042, as maintenance therapy for patients with high-risk locally advanced cervical cancer after chemo-radiation. Code: GEICO 78-C (ATOMICC)

Title: A phase 3 randomized, open-label, active-comparator controlled clinical study of pembrolizumab versus platinum doublet chemotherapy in participants with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma in the first-line setting (KEYNOTE-C93/GOG-3064/ENGOT-en15). Code: MK-3475-C93/GOG-3064/ENGOT-en15. 

Title: A multicentre, phase 3, double-blind, placebo-controlled study comparing chemo-immunotherapy (paclitaxel-carboplatin- oregovomab) vs chemotherapy (paclitaxel-carboplatin- placebo) in patients with advanced epithelial ovarian, fallopian tube or peritoneal carcinoma. Code: QPT-ORE-005 (FLORA-5)

Title: A phase 2 open-label randomized study of farletuzumab ecteribulin (MORAb-202), a folate receptor alpha-targeting antibody-drug conjugate, versus investigator’s choice chemotherapy in women with platinum-resistant high-grade serous (HGS) ovarian, primary peritoneal, or fallopian tube cancer. Code: CA116001 / MORAB-202-G000-205

Title: A phase III, open-label, multicentre, randomized trial of adjuvant palbociclib in combination with endocrine therapy versus endocrine therapy alone for patients with hormone receptor positive / HER2-negative resected isolated locoregional recurrence of breast cancer (POLAR). Code: IBCSG 59-19 / BIG 18-02 (POLAR)

Title: A phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of inavolisib plus palbociclib and fulvestrant, versus placebo plus palbociclib and fulvestrant in patients with PIK3CA-mutant, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer. Code: WO41554

Title: IPATHER: A phase Ib study of ipatasertib, an AKT inhibitor, in combination with pertuzumab plus trastuzumab in patients with PI3KCA-mutant, HER2-positive locally advanced or metastatic breast. Code: SOLTI-1507 (IPATHER)

Title: Phase III postneoadjuvant study evaluating Sacituzumab Govitecan, an antibody drug conjugate in primary HER2-negative breast cancer patients with high relapse risk after standard neoadjuvant treatment – SASCIA. Code: SASCIA _ GBG 102

Title: Chemotherapy-free pCR-guided strategy with subcutaneous trastuzumab-pertuzumab and T-DM1 in HER2-positive early breast cancer (PHERGAIN-2). Code: MedOPP293_PHERGAIN-2

Title: A randomized phase II study to evaluate the incidence of discontinuations due to diarrhoea at 3 cycles in patients with early-stage HER2-positive (HER2+), hormone receptor-positive (HR+) breast cancer treated with neratinib plus loperamide prophylaxis, versus neratinib with initial dose escalation plus PRN loperamide prophylaxis, versus neratinib plus loperamide plus colesevelam prophylaxis (DIANER Study). Code: GEICAM/2018-06_DIANER

Title: A randomized, double-blind, phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for metastatic HER2+ breast cancer (HER2CLIMB-05). Code: SGNTUC-028

Title: A phase III, randomized, open-label, multicentre study evaluating the efficacy and safety of adjuvant Giredestrant compared with physician’s choice of adjuvant endocrine monotherapy in patients with oestrogen receptor-positive, HER2-negative early breast cancer. Code: GO42784 (lidERA)

Title: Multicentre open-label, phase II trial, to evaluate the efficacy and safety of nal-IRI for progressing brain metastases in patients with HER2-negative breast cancer. Code: MedOPP107-

Title: HER2-PREDICT: Translational study of tumour samples from the DS8201-A-U301 and DS8201-A-U302 trials. Code: SOLTI-1804 (Her2Predict)

Title: A phase 3, multicentre, randomized, open-label, active-controlled study of trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in participants with high-risk HER2-positive primary breast cancer who have residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy. Code: DS8201-A-U305 (DESTINY-Breast05)

Title: A randomized, non-comparative, open-label, phase 1b/2 study of nadunolimab in combination with gemcitabine plus carboplatin in patients with advanced triple negative breast cancer (TRIFOUR Study). Code: CAN04CLIN005

Title: Neoadjuvant and adjuvant ribociclib and endocrine therapy for clinically high-risk oestrogen receptor-positive (ER+) and HER2-negative (HER2-) breast cancer. Code: SOLTI-1911 (RIBOLARIS)

Title: A phase III, multicentre, open-label study of ribociclib versus palbociclib in patients with advanced hormone receptor-positive/HER2-negative/HER2-enriched breast cancer (HARMONIA trial). Code: SOLTI-2101_HARMONIA

Title: An open-label, randomized, non-comparative phase 2 study of ARV-471 or anastrozole in post-menopausal women with ER+/HER2- breast cancer in the neoadjuvant setting. Code: ARV-471-BC-201 (TRIO 48)

Title: A randomized, double-blind, placebo-controlled, phase 3 study of pembrolizumab plus chemotherapy, versus placebo plus chemotherapy for the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer (KEYNOTE-B49). Code: MK3475-B49

 

Title: A phase 3, randomized, double-blind study of encorafenib and binimetinib plus pembrolizumab, versus placebo plus pembrolizumab in participants with BRAF V600E/K mutation-positive metastatic or unresectable locally advanced melanoma. Code: C4221016 STARBOARD

Title: A phase 3 trial of fianlimab (REGN3767, ANTI-LAG-3) + cemiplimab versus pembrolizumab in patients with previously untreated unresectable locally advanced or metastatic melanoma. Code: R3767-ONC-2011

Title: A phase 4, randomized, open-label, multicentre efficacy and safety study of standard dose of radium-223 dichloride vs. standard doses of novel anti-hormonal therapy (NAH) in patients with bone domi-dominant metastatic castration-resistant prostate cancer progressing during/after a line of NAH. Code: BAY 88-8223 / 20510

Title: CYCLONE 3: A phase 3, randomized, double-blind, placebo-controlled study of abemaciclib in combination with abiraterone plus prednisone in men with high-risk metastatic hormone-sensitive prostate cancer. Code: I3Y-MC-JPEG

 

Title: A randomized, open-label, phase 3 study to evaluate Zimberelimab and Domvanalimab in combination with chemotherapy, versus pembrolizumab with chemotherapy for the first-line treatment of patients with metastatic non-small cell lung cancer with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumour aberrations. Code: GS-US-626-6216 _ STAR-121

Title: A phase 1b, open-label study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumour activity of MEDI5752 in combination with axitinib in subjects with advanced renal cell carcinoma. Code: D7980C00003 (MEDI5752)

Title: TiNivo-2: A phase 3, randomized, controlled, multicentre, open-label study to compare tivozanib in combination with nivolumab to tivozanib monotherapy in subjects with renal cell carcinoma who have progressed following one or two lines of therapy where one line has an immune checkpoint inhibitor. Code: AVEO AV-951-20-304

Title: A multicentre, double-blind, randomized, phase 3 study to compare the efficacy and safety of belzutifan (MK-6482) plus pembrolizumab (MK-3475) versus placebo plus pembrolizumab, in the adjuvant treatment of clear cell renal cell carcinoma (CRcc) post nephrectomy (MK-6482-022). Code: MK-6482-022

Title: Phase II multicentre trial of palbociclib in second line of advanced sarcomas with CDK4 overexpression. Code: GEIS 51

Title: A phase II study of durvalumab (MEDI4736) plus tremelimumab for the treatment of patients with progressive, refractory advanced thyroid carcinoma (The DUTHY Trial). Code: GETNE T1812 (DUTHY)

Title: A phase 1 dose escalation and cohort expansion study of TSR-042, an anti-PD-1 monoclonal antibody, in patients with advanced solid tumours. Code: 4010-01-001 (TSR-042) GARNET

Title: Phase 1/2 multicentre study of the safety, pharmacokinetics, and preliminary efficacy of APL-101 in subjects with non-small cell lung cancer with c-Met EXON 14 skip mutations and c-Met dysregulation advanced solid tumours. Code: Apollomics (APL-101-01)

Title: A phase 1/2, open-label, multicentre, first-in-human study of the safety, tolerability, pharmacokinetics, and anti-tumour activity of TPX-0005 in patients with advanced solid tumours harbouring ALK, ROS1, or NTRK1-3 rearrangements (TRIDENT-1). Code: TPX-0005-01 (TRIDENT-1)

Title: A phase 1/2, multicentre, open-label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of anti-tumour activity of JAB-21822 monotherapy and combination therapy in adult patients with advanced solid tumors harbouring KRAS G12C mutation. Code: JAB-21822-1001

Title: A first-in-human study of mutant-selective PI3Kα inhibitor, RLY-2608, as a single agent in advanced solid tumour patients and in combination with fulvestrant in patients with advanced breast cancer. Code: RLY-2608-101

Title: A single-arm, open-label, multicentre phase 2 study to evaluate the efficacy and safety of taletrectinib in patients with advanced or metastatic ros1 positive NSCLC and other solid tumours. Code: AB-106-G208

Title: Phase 1/2 dose escalation and expansion study evaluating MCLA-129, a human anti-EGFR and anti-c-MET bispecific antibody, in patients with advanced NSCLC and other solid tumours. Code: MCLA-129-CL01

Title: A phase III, double-blind, multicentre, randomized study of atezolizumab (Anti-PDL1 antibody) versus placebo as adjuvant therapy in patients with high-risk muscle-invasive bladder cancer who are ctDNA positive following cystectomy. Code: BO42843 (IMVigor011)

Title: A randomized phase II study comparing 3 vs 6 cycles of platinum-based chemotherapy prior to maintenance avelumab in advanced urothelial cancer. Code: DISCUS

Title: A phase 3, randomized, open-label study to evaluate perioperative enfortumab vedotin plus pembrolizumab (MK-3475) versus neoadjuvant gemcitabine and cisplatin in cisplatin-eligible participants with muscle-invasive bladder cancer (KEYNOTE-B15 / EV-304). Code: MK-3475-B15

Title: A multicentre, randomized, double-blind, parallel-group, placebo-controlled, phase 2 study to assess the efficacy and safety of ATX01 (topical amitriptyline hydrochloride 10% and 15% w/w) in comparison to placebo, in cancer survivor adult patients with chemotherapy-induced peripheral neuropathy (CIPN). Code: ATX01-22-01-CIPN

Title: A multicentre, open-label, phase 3 study to evaluate the long-term safety and efficacy in participants who are currently on treatment or in follow-up in studies that include pembrolizumab. Code: MK3475-587

Urology

Title: Multicentre clinical trial with a healthcare product associated with a drug in authorised therapeutic use for the treatment of NMIBC evaluating the efficacy and tolerability of adjuvant treatment with EMDA-MMC versus standard BCG, and the efficacy of the urinary biomarker MCM5 ADXBLADDER® in the detection of tumour recurrence in patients with High Grade NMIBC. Code: CUETO 1801

Title: A double-blind randomized phase III trial evaluating the efficacy of ADT +/- darolutamide in de novo metastatic prostate cancer patients with vulnerable functional ability and not elected for docetaxel or androgen receptor targeted agents. Code: PEACE 6 – Vulnerable

Dermatology

Title: A phase 4, multi-centre, randomized, evaluator-blinded, active-controlled study to determine the incidence of squamous cell carcinoma and evaluate the long-term safety of tirbanibulin 10 mg/g ointment and diclofenac sodium 3% gel for the treatment of adult patients with actinic keratosis on the face or scalp. Code: M-14789-41. AKTIVE STUDY (ALM 1061)

Title: Open phase IV study to assess the impact of tirbanibulin on the wellbeing of patients with actinic keratoses (TIRBASKIN). Code: M-14789-42 (TIRBASKIN)

How to participate

Patients always sign an informed consent form stating that they agree to participate in the trial and that they have been given all the relevant information.

Patients are free to decide whether or not to participate in a clinical trial; they may only join one and they can leave at any time if they wish.

Clinical trials are regulated by law and require the approval of both the hospital’s Board and the Ethics Committee.

Scientific studies

These are research projects that aim to evaluate a certain aspect or factor of a drug that affects the treatment of a group of patients.

The aim of these studies is to answer questions after observing the effects of authorised drugs or standard treatments in patients, taking into account their genetic characteristics.