Clinical studies

The goal of clinical studies is to evaluate and introduce new treatment of cancer. The clinical trial are conducted in the frame or under auspicies of international association, or as an EU funded projects, sponsored by pharmaceutical companies or are the results of our own knowledge.

Clinical studies recruiting patients

Breast cancer

Code	Research title	Principal Investigator	Consents informed
KATE3	A randomized, multicenter, double-blind, placebo-contolled phase III study of the efficacy and safety of trastumab emtasine in combination with atezolizumab or placebo in patients with HER2 positive locally advanced or metastatic breast cancer who have received trastuzumab-(+/- pertuzmab) and taxane-based therapy	Domen Ribnikar	KATE3.pdf
EPIK-B3	EPIK-B3: A Phase III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with nab-paclitaxel in patients with advanced triple negative breast cancer with either phosphoinositide-3-kinase catalytic subunit alpha (PIK3CA) mutation or phosphatase and tensin homolog protein (PTEN) loss without PIK3CA mutation	Simona Borstnar
IMMUNOBREAST	THE USE OF AUTOLOGOUS IMMUNOHYBRIDOMAS IN TREATMENT OF PATIENTS WITH STAGE II AND III TRIPLE NEGATIVE BREAST CANCER	Simona Borstnar
LIDERA	A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF ADJUVANT GIREDESTRANT COMPARED WITH PHYSICIAN'S CHOICE OF ADJUVANT ENDOCRINE MONOTHERAPY IN PATIENTS WITH ESTROGEN RECEPTOR−POSITIVE, HER2-NEGATIVE EARLY BREAST CANCER	Simona Borstnar
PALMIRA	INTERNATIONAL, MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE II CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF CONTINUATION OF PALBOCICLIB IN COMBINATION WITH SECOND-LINE ENDOCRINE THERAPY IN HORMONE RECEPTOR-POSITIVE/HER2-NEGATIVE ADVANCED BREAST CANCER PATIENTS WHO HAVE ACHIEVED CLINICAL BENEFIT DURING FIRST-LINE PALBOCICLIB-BASED TREATMENT	Erika Matos
EUROPA	Exclusive endocrine therapy or radiation therapy for women aged ≥70 years with luminal A-like early stage breast cancer (EUROPA): a randomised phase 3 trial	Ivica Ratosa	5._EUROPA_INFORMED_CONSENT_FORM_ITA_V_3.0_20220315__002__en-GB.pdf

Respiratory cancers

Code	Research title	Principal Investigator	Consents informed
AGILI	Cisplatin with either alimta or gemcitabine in long infusion for mesothelioma: a randomised phase II trial	Viljem Kovač
APPLE	Feasibility and activity AZD9291 (osimertinib) treatment on Positive Plasma T790M in EGFR mutant NSCLC patients	Mojca Unk
IMreal	A non-interventional, multicenter, multiple cohort study investigating the outcomes and safety of Atezolizumab under real-world conditions in patients treated in routine clinical practice (MO40653)	Nina Turnšek
TRacKING	Real world European registry of NTRK fusions and other rare actionable fusions	Mojca Unk
ASTRES	A phase II, single-arm study of atezolizumab in patients with locally advanced, unresectable stage III non[1]small cell lung cancer who have not progressed after platinum-based concurrent chemoradiation	Martina Vrankar	informed_form_Master_ICF_v.1_MAIN_adapted_for_SVN_23Sep2021_FINAL.pdf informed_form__ICF_v.1_MAIN_adapted_for_SVN_23Sep2021_FINAL.pdf biosample_repository_RBR_adapted_for_SVN_23Sep2021_FINAL.pdf BIOPSY_adapted_for_SVN_23Sep2021_FINAL.pdf TISSUE_ICF_v.1_adapted_for_SVN_20Sep21_FINAL.pdf

Gastrointestinal cancer

Code	Research title	Principal Investigator	Consents informed
PREPARE	PREemptive Pharmacogenomic testing for Preventing Adverse drug REactions	Danijela Štrbac
PROMETCO	A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective	Janja Ocvirk

Skin cancers

Code	Research title	Principal Investigator	Consents informed
MINITUB	Prospective registry of Sentinel Node (SN) positive melanoma patients with minimal SN tumor burden who undergo Completion Lymph Node Dissection (CLND) or Nodal Observation.	Marko Hočevar
MelMarT	Melanoma Margins Trial (MelMarT) Phase III, multi-centre, multi-national randomised control trial investigating 1 cm v 2 cm wide excision margins for primary cutaneous melanoma	Barbara Peric

Urinary tract cancer

Code	Research title	Principal Investigator	Consents informed
	Treatment of radiation induced side effects with hyperbaric oxygen therapy	Helena Barbara Zobec Logar	Treatment of radiation induced side effects with hyperbaric oxygen therapy

Gynecological cancer

Code	Research title	Principal Investigator	Consents informed
	The role of citopathology to define morphologic, antigen and molecular characteristics of epithelial ovarian cancer for determining diagnosis, treatment options and evaluation of immune response	Erik Škof
	Individual approach in gynecological cancer brachytherapy	Helena Barbara Zobec Logar	Individual approach in gynecological cancer brachytherapy
EKT-gineko	Use of electrochemotherapy in women with vulvar cancer	Gregor Vivod

Head and neck cancers

Code	Research title	Principal Investigator	Consents informed
SmartGene	Treatment of head and neck skin cancers with interleukin 12 gene electrotransfer	Gregor Sersa, Primoz Strojan

Institute of Oncology

Sectors

For Patients

Clinical studies

Clinical studies recruiting patients

Breast cancer

Respiratory cancers

Gastrointestinal cancer

Skin cancers

Urinary tract cancer

Gynecological cancer

Head and neck cancers

Institute of Oncology Ljubljana

Sectors

For Patients

Institute of Oncology

Sectors

For Patients