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Clinica Radiotherapy Center Cluj este autorizata pentru desfasurarea studiilor clinice cu beneficiu terapeutic in cadrul specialitatilor de Oncologie Medicala si Radioterapie conform autorizatiilor.
1.MK-3475-992
A phase 3, randomized, double-blind, combination, placebo-controlled clinical trial to study the effi-cacy and safety of Pembrolizumab (MK-3475) in combination with chemotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC) (KEYNOTE-992)
2. MK-3475-975
A randomized, double-blind, placebo-controlled phase III study of Pembrolizumab (Mk-3475) versus placebo in patients with esophageal carcinoma receiving definitive concurrent chemoradiotherapy (KEYNOTE 975)
3. MK-7339-012
A phase 3 trial of Pembrolizumab (MK-3475) in combination with concurrent chemotherapy followed by Pembrolizumab with or without Olaparib versus concurrent chemotherapy followed by Durval-umab in participants with locally advanced stage III non-small cell lung cancer (NSCLC).
4. WO42633 ASTEFANIA
A phase III, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of adjuvant therapy with Atezolizumab or Placebo and Trastuzumab Emtansine in HER2-Positive breast cancer at high risk of recurrence after preoperative therapy.
5. FLORA-5 (QPT-ORE-005)
Phase III, double-blind, placebo-controlled study compares chemotherapy immunotherapy (Paclitax-el-Carboplatin-Oregovomab) versus chemotherapy (Paclitaxel-Carboplatin-Placebo) for patients with advanced epithelial ovarian, fallopian tube or peritoneal carcinoma.
6. MO41552 (ROCHE)
Phase III, randomized, open-label, multicentre study evaluating ENTRECTINIB versus CRIZOTINIB in patients with non-small cell bronchopulmonary neoplasm presenting with ROSI gene rearrange-ments, locally advanced or metastatic, with or without central nervous system metastases.
7. MS202359-0002
A randomized, double-blind, placebo-controlled trial. Two-arm Phase III study to evaluate the effica-cy and safety of xevinapant and radiotherapy versus placebo and radiotherapy for demonstrating, im-proving, disease-free survival in participants with resected squamous cell carcinoma of the head and neck who are at high risk for relapse and are not eligible for high-dose cisplatin.
8. JDQ443 – CJDQ443B12301
A randomized, controlled, open, phase III trial evaluating the efficacy and safety of JDQ443 versus docetaxel in previously treated subjects with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer.
9. LATIFY D533BC00001
A multicentre, open-label, randomized phase III trial of Ceralasertib plus Durvalumab versus Docet-axel in patients with advanced or metastatic non-small cell lung cancer without actionable genomic changes and whose disease progressed on or after prior anti-PD-L 1 therapy and platinum-based chemotherapy: LATIFY.
10. ASTEFANIA-WO42633
A study evaluating the efficacy, safety and pharmacokinetics of Atezolizumab when administered in combination with T-DM1 versus placebo plus T-DMI in HER2+ breast cancer patients with residual disease after neoadjuvant taxane-based therapy and HER2-targeted therapy.
11. MK-3475-D46
An open-label, multicentre, phase 3, randomized, active comparator-controlled clinical trial of Pem-brolizumab (MK-3475) in combination with Sacituzumab Govitecan versus MK-3475 monotherapy as first-line treatment in participants with PD L1 TPS greater than or equal to 50% metastatic non-small cell lung cancer.
12. MK-7902-014
A phase III, randomized trial to evaluate the safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/Mk-7901) + Chemotherapy compared to standard of care for participants with metastatic esophageal carcinoma.
13. MK-6482-011
A multicentre, double-blind, randomized phase 3 trial to compare the efficacy and safety of Belzuti-fan (MK-6482) plus Pembrolizumab (MK3475) versus Placebo plus Pembrolizumab in the adjuvant treatment of post nephrectomy clear cell renal cell carcinoma (ccRCC) (MK-6481-022).
14. MK-7684A-006
Phase 3 open-label study of MK-7684A (Vibostolimab co-formulation with Pembrolizumab) in com-bination with concurrent chemoradiotherapy followed by MK-764A versus concurrent chemoradio-therapy followed by Durvalumab in patients with unresectable, locally advanced, stage III NSCLC.
15. ELI-LYLY JPEG
A phase III, randomized, double-blind, placebo-controlled trial of abemaciclib in combination with abiraterone plus prednisone in men with high-risk hormone-sensitive metastatic prostate cancer.
16. REGENERON R3763-ONC-2011
A phase III protocol to FIANLIMAB (REGN3767, ANTI-LAG-3) + CEMIPLIMAB versus PEM-BROLIZUMAB in patients with previously untreated avascular or metastatic local melanoma.
17. BYL719 – CBYL719C2303
EPIK-B5: Phase III, randomized, double-blind. The study is a placebo-controlled trial of alpelisib (BYL719) in combination with fulvestrant for postmenopausal men and women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation that has progressed on or after aro-matase inhibitor and a CDK4/6 inhibitor.
1. MK-3475-671
Phase III, randomized, double-blind, platinum-doublet chemotherapy +/- Pembrolizumab (MK-3475) trial as neoadjuvant/adjuvant therapy for participants with resectable IIB or IIIA non-small cell lung cancer (NSCLC) (KEYNOTE-671).
2. ACZ885/Canakinumab
A Phase III, multicentre, randomized, double-blind, placebo-controlled, randomized trial evaluating the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with AJCC/UICC v. 8 stages II-IIIA and IIIB (T> 5cmN2) completely resected (R0) small cell lung cancer (NSCLC)
3. CA045-001
Phase III, randomized, open-label study of NKTR-214 in combination with Nivolumab versus Nivolumab in subjects with previously untreated inoperable or metastatic melanoma.
4. ASTELLAS 8951-CL-0302
Phase III, global, multi-centre, double-blind, randomized, efficacy study of Zolbetuximab (IMAB362) Plus CAPOX compared to CAPOX Placebo Plus as first-line treatment of subjects with claudin (CLDN) 18.2-positive, HER2-negative, unresectable or locally advanced metastatic gastric or gas-troesophageal adenocarcinoma (GEJ).
5. MK-7339-008
A phase III trial of Pembrolizumab in combination with Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) followed by Pembrolizumab with or without maintenance Olaparib in the first-line treat-ment of metastatic non-small cell lung cancer (NSCLC)
6. MM-398-01-03-04 IPSEN
A phase III, randomized, open-label, chemotherapy trial of Irinotecan (ONIVYDE) versus Topotecan in patients with small cell lung cancer who have progressed after or during first-line platinum-based therapy.
7. CA209-77T
A phase 3, randomized, double-blind trial of neoadjuvant chemotherapy plus Nivolumab versus neo-adjuvant chemotherapy plus placebo followed by surgical resection and adjuvant treatment with Nivolumab or Placebo for participants with resectable stage II-IIIB non-small cell lung cancer.
8. CA20973L
Phase III, randomized, open label study comparing Nivolumab plus concurrent chemoradiotherapy (CCRT) followed by Nivolumab plus Ipilimumab or Nivolumab plus CCRT followed by Nivolumab vs CCRT followed by Durvalumab in subjects with previously untreated locally advanced non-small cell lung cancer ( LA NSCLC).
9. CA209-7FL
Phase III, randomized, multicentre, double-blind, placebo-controlled study. Nivolumab versus place-bo in combination with neoadjuvant chemotherapy and adjuvant endocrine therapy in patients with high-risk epidermal growth factor receptor-positive (ER+), receptor-negative 2-negative (HER2-) primary breast cancer
10. GSK-209227
A randomized, double-blind, adaptive, phase II/III trial of GSK3359609 in combination with Pem-brolizumab and 5FU-Platinum chemotherapy versus placebo in combination with Pembrolizumab plus 5FU-Platinum chemotherapy for the first-line treatment of recurrent or metastatic squamous cell head and neck cancer.
11. NBTXR3
Phase 2/3, multicentre, randomized study to compare the efficacy of NBTXR3, implanted as intra-tumoral injection and activated by radiotherapy, versus radiotherapy administered as monotherapy in patients with locally advanced extremity and trunk wall soft tissue sarcoma
12. ELISSAR – MO39874
A multicentre, open label, phase IIIB, single arm, ATEZOLIZUMAB (TECENTRIK) and NAB-PACLITAXEL safety trial in the treatment of locally advanced unresectable or metastatic triple nega-tive breast cancer.
13. SANOFI EFC15858 CARMEN-LC03
A randomized, open label, phase III, combination trial of SAR408701 versus DOCETAXEL as first-line treatment in non-squamous, non-small cell metastatic lung cancer in patients with CEACAM5-positive mutation.
14. GSK 213403 (NON SMALL)
A randomized, phase II, double-blind trial evaluating the efficacy of DOSTARLIMAB plus CHEMO-THERAPY versus PEMBROLIZUMAB plus CHEMOTHERAPY in non-squamous, non-small cell metastatic lung cancer.
15. PEACE 1
A prospective, randomized, phase III trial of androgen deprivation therapy, with or without local radi-otherapy, with or without abiraterone acetate and prednisone in patients presenting with hormone-naive metastatic prostate cancer.
16. PCR3003
A randomized, double-blind, placebo-controlled trial of a GNRH Agonist versus GNRH Agonist plus placebo in subjects with high-risk localized or locally advanced prostate cancer treated with primary radiotherapy.
17. ASTELLAS 9785-CL-0335
A multinational, phase III, randomized, double-blind, placebo-controlled, efficacy and safety study of enzalutamide androgen deprivation therapy versus placebo plus ADT in patients with metastatic hor-mone-sensitive prostate cancer.
18. SAMSUNG SB8
Phase III, randomized, double-blind, multicentre study to compare efficacy, safety, pharmacokinetics and immunogenicity between SB8 and Avastin in subjects with metastatic or recurrent NSCLC.
19. EMR 100070-005
Phase III, open-label, multicentre trial of avelumab versus platinum doublet as first-line treatment of recurrent or stage IV PD-L1+ small cell lung cancer.
20. ASTELLAS 8273-CL-0302
Open-label, phase III trial of ASP8273 versus Erlotinib or Gefitinib in the first-line treatment of pa-tients with stage IIIB/IV non-small cell lung cancer tumours with activating EGFR mutations
21. CA209-227
Open-label, randomized, phase III trial of Nivolumab, or Nivolumab plus Ipilimumab, versus plati-num-doubled chemotherapy in subjects with chemotherapy-naive stage IV or recurrent small cell lung cancer.
22. B7391003
Phase III, randomized, double-blind study of PF-06439535 and paclitaxel-Carboplatin versus Bevaci-zumab and Paclitaxel-Carboplatin in patients with line I NSCLC
23. FKB238-002
A randomized, parallel, double-blind trial to compare the efficacy and safety of FKB238 with Avas-tin® in the first-line treatment of patients with advanced/recurrent non-squamous lung cancer in combination with Paclitaxel and carboplatin
24. M14-361
Phase II, randomized, double-blind study of Veliparib in combination with Carboplatin and Etoposide as therapy for the treatment of naive disease in extensive stage small cell lung cancer.
25. CASPIAN
A phase III, randomized, multicentre, open-label, comparative study to determine the efficacy of Dur-valumab or Durvalumab and Tremelimumab in combination with platinum-based chemotherapy for first-line treatment in patients with extensive disease (stage IV) in small cell lung cancer (SCLC)
26. SOLAR-1
Randomized, double-blind, placebo-controlled, phase III trial in combination with fulvestrant for men and postmenopausal women with HER2-negative, advanced HER2-positive breast cancer that pro-gressed during or after aromatase inhibitor (AI) treatment
27. EMR 100070-008
Phase III, open-label, multicentre study of avelumab in subjects previously treated as third-line thera-py for recurrent, metastatic gastric adenocarcinoma
28. EMR 100070-007
Phase III, open-label, multicentre study of avelumab maintenance therapy versus continuation of first-line chemotherapy in subjects with unresectable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.
29. CA209-577
Phase III, randomized, double-blind, multicentre, investigational clinical trial of adjuvant treatment with nivolumab or placebo in subjects with resected esophageal or esogastric junction cancer
30. CA209-274
Phase III, randomized, double-blind, multicentre study of adjuvant Nivolumab versus placebo in sub-jects with highly invasive urothelial carcinoma
31. BBI608-336
Phase III, randomized, double-blind, placebo-controlled trial comparing BBI608 plus weekly paclitaxel to placebo plus weekly paclitaxel in adult patients with previously treated advanced stage gastric and esogastric junction adenocarcinoma (JEG)
32. SAUL MO29983
Open-label, single-arm, multicentre, safety study of Atezolizumab in locally advanced or metastatic urothelial or metastatic carcinoma of the urinary tract
33. PALO 15-17
Phase III study of a new 5-HT3 antagonist – Palonosetron for patients with high emetogenic risk chemotherapy administered in two different modalities: bolus 30 sec or IV infusion 30 min
34. MK-7339-002
This is a phase II study of Olaparib monotherapy in participants with previously mutated cancer, ho-mologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD), advanced cancer positive
35. CO-338-087 ATHENA
A multicentre, randomized, double-blind, placebo-controlled phase 3 trial in patients with ovarian cancer evaluating Rucaparib and Nivolumab as maintenance treatment after response to platinum-based chemotherapy in the frontline.
36. BGB-A317-306
Phase III, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of Tislelizumab (BGB-A-317) in combination with chemotherapy as first-line treatment in patients with recurrent or metastatic, unresectable, locally advanced esophageal squamous cell carcinoma.
37. MK-7339-006
A phase III trial of Pembrolizumab in combination with Pemetrexed/Platinum (Carboplatin or Cispla-tin) followed by Pembrolizumab and Maintenance Olaparib vs. Maintenance Pemetrexed in the first-line treatment of participants with metastatic Nonsquamous Non-Cell-Small Cell Lung Cancer
38. GlaxoSmithKline-209229
Phase II/III, randomized, double-blind, adaptive design, trial evaluating GSK3359609 or placebo in combination with Pembrolizumab for the first-line treatment of patients with relapsed/metastasized, PD-L1 positive head and neck squamous cell carcinoma.
39. BCD-100-3/DOMAJOR
A multicentre, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of BCD-100 in combination with Pemetrexed+Cisplatin/Carboplatin compared with Placebo in com-bination with Pemetrexed+Cisplatin/ Carboplatin as first-line treatment of subjects with Nonsqua-mous Non-Small Cell Lung Cancer (NSCLC)
40. D081RC00001 DUO-O
A randomized, double-blind, placebo-controlled, multicentre Phase III trial of Durvalumab in combi-nation with chemotherapy and Bevacizumab followed by maintenance Durvalumab, Bevacizumab, and Olaparib in newly diagnosed ovarian cancer patients (DUO-O)
Coordinating doctors
• Prof. Dr. Kacso Gabriel, primary physician radiotherapy, primary physician medical oncology – gabriel.kacso@amethyst-radiotherapy.com
• Dr. Zahu Renata, primary physician radiotherapy – renata.zahu@amethyst-radiotherapy.com
• Dr. Bodale Carmen, primary medical oncologist – carmen.bodale@amethyst-radiotherapy.com
• Dr. Manolescu Vlad, primary medical oncologist – vlad.manolescu@amethyst-radiotherapy.com
• Dr. Ungureanu Andrei, primary medical oncologist – andrei.ungureanu@amethyst-radiotherapy.com
Amethyst Clinic Cluj
Contact persons:
Monica Pop
Phone: 0724.326.348
Martis Ionela
Phone: 0723.398.133
Email address: studii.clinice@amethyst-radiotherapy.com
Phone: 021.9368
Address: no 42, Drumul Odăi, Otopeni
Phone: 021.9368
Address: no 486G, Răzoare Street, Florești
Phone: 021.9368
Address: no 12, Bela Bartok Street, Dumbrăvița, Timiș County
Phone: 021.9368
Address: no 10, Louis Pasteur Street, Alba-Iulia, Alba County
