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Studies oncologie

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Research unit

De research unit is een onderdeel van de oncologische afdeling binnen het UZA. Het doel van de research unit is nieuwe, betere en steeds meer doeltreffendere behandelingen vinden om kankerpatiënten te behandelen. Klinische studies zijn hiervoor de beste methode. Tijdens deze klinische studies kunnen onze onderzoekers bepalen welke behandelingen veiliger, effectiever en beter zijn dan huidige behandelingen. De research unit bestaat uit artsen, studie coördinatoren, logistieke medewerkers, studie verpleegkundigen, pathologen en administratieve medewerkers. 

Hoe kan ik de research unit bereiken?

Heb je vragen over de studies binnen de research unit? Neem gerust contact met ons op via 03 821 55 80, 03 821 53 07 of via research [dot] oncologie [at] uza [dot] be

Studies fase 1/basket oncologie 

Title Tumortype  Line of therapy Study information Status Register 
STARTRK-2: Basket study of Entrectinib for patients with tumors that harbor NTRK1/2/3, ROS1 or ALK gene rearrangements. Solid   All
  • Open cohorts: NTRK fusions (all tumor types) and ROS1 fusions (all tumors except NSCLC)
  • Entrectinib PO 600 mg daily
Open NCT02568267
TVEC: phase 1b/2 of Talimomgene Laherparepvec injected into liver tumors alone and in combination with Pembrolizumab
  • HCC
  • HR+ Breast cancer
  • TNBC
  • Cutaneous squamous cell carcinoma
  • Basal cell carcinoma
  • CRC
≥1L

 TVEC intrahepatic Q3W - Pembrolizumab Q3W IV 

Open NCT02509507
BP40234: Phase 2 with RO6874281, an immunocytokine consisting of IL-2V targeting Fibroblast Activation protein A (FAP) in combination with atezolizumab (anti-PDL1). Solid Multiple
  • COHORT J: squamous cervix CPI naïve Q3W schedule
  • COHORT N: squamous cervix CPI naïve QW/Q2W schedule 
Closed NCT03386721
alloSHRINK: Phase 1 of CYAD-101 (CAR-T cells) in combination with FOLFOX in mCRC CRC >1L
  • CAR-T cells will be administered with the first 3 cycles of FOLFOX. 
  • Hospitalization of 4 days after CAR-T administration required
Closed NCT03692429
Precision 2: phase 2 with afatinib in tumors with EGFR, HER2 or HER3 mutation followed by addition of paclitaxel to afatinib at disease progression Solid >1L
  • Exclusion: NSCLC with EGFR mutation
  • Afatinib 40mg/day with increase to 50 mg.
 Open  NCT03810872
BP29842: Phase 1a/1b with RO6874281, an immunocytokine consisting of IL-2V targeting Fibroblast Activation protein A (FAP) in combination with cetuximab  SSCHN All
  • Can have had standard or experimental treatment (excl. IL-2 compounds).
  • Previous treatment with cetuximab is allowed.
Open NCT02627274

AMG404: A Phase 1 study with AMG 404 (a PD-1 antibody) in patients with advanced solid tumors

  • Melanoma
  • SCLC
  • NSCLC PD-L1 +
  • HNSCC PD-L1 +
  • Urothelial PD-L1 +
  • Gastric/GEJ adone PD-L1 +
  • Esophageal, squamous, PD-L1 +
  • Cervical PD-L1 +
  • HCC
  • Merkel Cell Carcinoma
  • SCC of the skin
  • RCC, clear cell
  • Undifferentiated pleiomorphic/malignant fibrous histiocytoma
  • Poorly differentiated and/or dedifferentiated liposarcoma
  • Alveolar Soft Tissue Sarcoma
  • Angiosarcoma
  • Thymic carcinoma
  • Nasopharyngeal carcinoma, EBV positive
  • Mesothelioma
  • MSI-H or MMR-deficient tumors
All, no prior anti-PD-(L)1 or CTLA-4
  • AMG 404 IV Q4W

  • Archival tissue <1y old or fresh biopsy

Slots NCT03853109

 

CVPM087A2101: Phase Ib study of gevokizumab in combination with standard of care anti-cancer therapies in patients with metastatic colorectal cancer, gastroesophageal cancer and renal cell carcinoma

CRC 1L/2L
  • 1L: 2 weeks gevokizumab monotherapy followed by gevokizumab + mFOLFOX6 + bevacizumab
  • 2L: 2 weeks gevokizumab monotherapy followed by gevokizumab + FOLFIRI + bevacizumab
  • CRP ≥ 10mg/L 
Closed  NCT03798626 

MS200647-0024: Phase Ib/II study of M7824 in combination with chemotherapy in participants with stage IV NSCLC

NSCLC 1L/2L
  • Cohort A: 1L non-squamous NSCLC: Cisplatinum/Carboplatinum + Pemetrexed + M7824 Q3W
  • Cohort B: 1L squamous or non-squamous NSCLC: Carboplatinum + nab-paclitaxel/paclitaxel + M7824 Q3W
  • Cohort D: 2L squamous or non-squamous NSCLC: Docetaxel + M7824 Q3W --> Closed
Open  NCT03840915 

MiMe-A: Multiorgan Metabolic imaging response assessment of Abemaciclib

Solid All
  • Esophageal adenocarcinoma --> limited slots
  • Esophageal squamous cell carcinoma --> limited slots
  • Cholangiocarcinoma --> Closed
  • Urothelial cancer
  • Endometrial cancer --> Closed
Hold NCT03339843 

D419NC00001 (Medimmune): A phase ½ of Durvalumab and Monalizumab in adult subjects with select advanced solid tumors

CRC 3L
  • RAS/BRAF WT MSS
  • No prior anti-EGFR therapy 
  • Randomization 
    - cohort 2A: monalizumab Q2W + Durvalumab Q4W + Cetuximab Q2W
    - cohort 2B: monalizumab Q2W + Cetuximab Q2W 
Closed  NCT02671435

AMG510: Phase 1/2 open label study with AMG510 monotherapy in subjects with advanced solid tumors with KRAS p.G12C mutation

Solid Multiple
  • KRAS p.G12C mutation (central confirmation)
  • CRC: progression after 5-FU, oxaliplatin and irinotecan --> Closed
  • NSCLC: progression after anti-PD1/anti-PDL1 AND/OR platinum-based combination therapy AND targeted therapy. Not more than 3 prior lines of therapy. --> Closed
  • Solid: progression after 1st line or ineligible for 1st line treatment --> Open

Open

NCT03600883

CV202-103: A Phase 1b/2 study of BMS-813160 in combination with chemotherapy or Nivolumab in patients with advanced solid tumors

CRC and Pancreas CRC: 2L and Pancreas: 1L
  • CRC: previous treated with one line of oxaliplatin-based systemic therapy in metastatic setting or progression on or within 6 months of adjuvant oxaliplatin based chemotherapy
  • Pancreas: adenocarcinoma previously untreated or recurring systemically after surgery or >6 months post adjuvant therapy. Local recurrence alone not allowed.
  • Able to swallow tablets
  • Mandatory pre- and on-treatment biopsies
Closed 

 

NCT03184870

BP41054: A Phase IB Study To Evaluate Safety And Therapeutic Activity Of RO6874281, An Immunocytokine, Consisting Of Interleukin-2 Variant Targeting Fibroblast Activation Protein-Α, In Combination With Pembrolizumab (Anti-Pd-1), In Participants With Advanced And/Or Metastatic Melanoma 

CPI experienced melanoma All, prior anti-PD-(L)1 as last line
 
  • Cutaneous unresectable stage III or stage IV melanoma. 
  • Prior adjuvant anti-PD(L)1 or anti-CTLA-4 is permitted if relapse occurred during or < 6 months after completion.
Open

 

NCT03875079

RAGNAR: A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and Selected FGFR Gene Alterations

Solid Tumors >1L
  • FGFR mutations and FGFR fusions (NO amplifications!)
  • Central testing allowed for:
      •      Glioblastoma
      •      Gliomas
      •      SCCHN
      •      Sarcoma
      •      Cholangio
      •      Endometrial
      •      Cervix
      •      Ovarian
      •      NSCLC
      •      RCC
      •      Esophageal
      •      Gastric
      •      Breast: only HR+
      •      HCC
      •      Pancreatic
  • Oral medication

 

Open

NCT04083976

KISIMA-01: Phase Ib Study to evaluate the safety, tolerability and anti-tumor activity of ATP128, with or without BI 754091 in patients with stage IV CRC

CRC 2L
  • Ongoing PR or SD after completion of 1st line SOC therapy (min. 6 months) 
  • 1 liver lesion amenable to repeated biopsy
  • ATP128: chimeric recombinant protein vaccine
  • BI754091: anti-PD1
Hold

 

NCT04046445

BLU-667: A Phase 1/2 study of the highly-selective RET inhibitor, BLU-667, in patients with thyroid cancer, NSCLC and other advanced solid tumors

  • NSCLC: RET fusion
  • Other solid tumors: RET fusion
  • NSCLC: no prior platinum-based therapy
  • Other solid tumors: previously treated with SOC therapy
  • Oral medication 
Open 

NCT03037385

MIV-818: A Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of MIV-818 in Patients with Liver Cancer Manifestations

HCC, iCCA, colon, rectum and gastrid cancer

All 
  • Oral medication 
  • Mandatory on-treatment liver biopsy 
  • Child-Pugh A score 
Open 

 

NCT03781934

MCLA-145-CL01: A Phase 1, Open-label, Dose-escalation study of MCLA-145 in participants with advanced or metastatic malignancies 

All solid tumors 

<=4L
  • Dual CD137 + Anti-PD-L1 antibody 
  • Prior anti-PD-1 is allowed (max 1 line)
  • Mandatory pre- and on-treatment biopsy
  • Specific inclusion criteria for TNBC, melanoma, HNSCC and urothelial carcinoma
Slots

 

NCT03922204

SYD985.004:A Phase 1 study with the antibody-drug conjugate SYD985 in combination with Niraparib in patients with HER2-expressing locally advanced or metastatic solid tumors 

All solid tumors 

All
  • SYD985 IV Q3W + Niraparib oral 
  • HER2 tumor status at least 1+ assessed by IHC
Open 

NCT04235101

GO40987: A phase I, multicenter, open-label, preoperative, short-term window study of GDC-9545 in postmenopausal women with Stage I-III operable, estrogen receptor-positive breast cancer.

Breast

1L
  • ER+/Her2-negative unilateral breast cancer eligible for primary surgery
  • Primary tumor >= 1.5 cm
  • Postmenopausal women 
  • Oral medication QD for 15d prior to surgery 
Open 

 

NCT03916744

INCB86550-102: A Phase 1 study with INCB086550 in patients with advanced solid tumors

  • MSI-H/d MMR tumors
  • Cutaneaous squamous cell carcinoma
  • HCC
  • PDL-1 positive esophageal squamous cell carcinoma
  • Merkel cell carcinoma
  • SCLC
  • PDL-1 positive mesothelioma
  • Any PDL-1 amplified tumor (9p24.1)
  • Nasopharyngeal carcinoma
  • Cyclin-dependent kinase 12 mutated tumors (loss of function, not amplification)
  • Basal cell carcinoma (unresectable or metastatic)
  • RCC with sarcomatoid features
  • Clear cell ovarian or endometrial carcinoma
  • DNA polymerase epsilon mutated tumors (P286R and V411L)

Other tumor types with approval of Medical Monitor

 
  • Progressed after SOC or intolerant/ineligible for SOC
  • No limit to number of prior treatment regims 
  • Oral anti-PDL-1
  • Mandatory screening + on treatment biopsy 
Open 

NCT03762447

Full molecular testing by RNA/DNA next generation sequencing to detect RNA/DNA alterations (including NRG1 fusions) 

Locally advanced/metastatic pancreatic adenocarcinoma All 
  • Whole genome sequencing of RNA/DNA (200 genes) 
  • ≤ 60 years old at time of diagnosis
  • KRAS mutated NOT eligible 
   

Studies borstkanker 

Title Tumortype Line of therapy Study information Status Register
NATALEE: A Phase 3, Randomized, Open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with HR positive, HER2-negative, early breast cancer. HER2-, HR+ Adjuvant
  • Stage III
  • max. 12 months on adjuvant HT
  • ARM A: Ribociclib 400 mg + Letrozole (+/- Goserelin)
  • ARM B: Letrozole (+/- Goserelin)
Hold NCT03701334
The AURORA PROGRAM: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer All 1-2L
  • Molecular study, no study treatment
  • Blood samples every 6 months and at progression
  • Biopsy after first or second progression and prior to next line of therapy
Open NCT02102165
AMALEE: A phase II, randomized, open-label study to evaluate the safety and efficacy of 400 mg of ribociclib in combination with NSAI for the treatment of pre- and postmenopausal women with HR+, HER2- advanced breast cancer who received no prior therapy for advanced disease. HER2-/ER+ 1L
  • No prior therapy in advanced setting
  • Measurable disease per RECIST 1.1
  • Arm 1: Ribociclib 400 mg + NSAI
  • Arm 2: Ribociclib 600 mg + NSAI
Open NCT03822468
CAPitello291: Phase II study of Capivasertib + Fulvestrant vs Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer HER2-/ER+ 1-3L
  • Recurrence/PD on or within 12m of end of adjuvant AI or PD while on AI for aBC/mBC.
  • max. 2 prior ET for aBC/mBC
  • max. 1 prior chemotherapy for aBC/mBC
  • No prior Fulvestrant, SERDs, AKT, PI3K, and/or mTOR inhibitors
  • prior CDK4/6 inhibitors allowed (max. 50% of target)
  • Measurable disease per RECIST 1.1 or lytic bone only disease
  • FFPE tumour sample available
   
FORTRESS: Phase III, open-label trial comparing Balixafortide in combination with Eribulin vs Eribulin alone in patients with HER2 negative, locally recurrent or metastatic breast cancer. HER2- 3-5L
  • Min. 2 prior lines of chemotherapy in advanced/m+ setting
  • Prior AC and Taxane
  • Arm 1: Balixafortide (CXCR4 therapy)+ Eribulin
  • Arm 2: Eribulin
Open NCT03786094
CONTESSA TRIO: Phase II study of Tesetaxel + Three Differend PD-(L)1 Inhibitors in Patients with Triple-Negative, Locally Advanced or Metastatic Breast Cancer and Tesetaxel Monotherapy in Elderly Patients with HER2 Negative, Locally Advanced or Metastatic Breast Cancer. HER2- 1L
  • 1L chemo
  • Cohort 1: TNBC (nivolumab/pembroluzimab/atezoluzimab + tesetaxel)
  • Cohort 2: >= 65 years HR+ (tesetaxel)
  • Tesetaxel = oral taxane therapy
  • Archival tumor tissue available
Open NCT03952325
APTneo: Atezolizumab, Pertuzumab and Trastuzumab with chemotherapy as neoadjuvant treatment of HER2 positive early high-risk and locally advanced breast cancer. HER2+ Neo-adjuvant, adjuvant
  • unilateral, (T1cN1; T2N1; T3N0) or locally advanced non inflammatory (T3N1; T4; any T and N2-3) or inflammatory (T4d any N)
  • mandatory biopsy before Cycle 2
  • baseline LVEF > 55%
  • ARM A: neo-adj. chemotherapy + trastuzumab + pertuzumab; adjuvant trastuzumab + pertuzumab
  • ARM B: neo-adj. chemotherapy + trastuzumab + pertuzumab + atezolizumab; adjuvant trastuzumab + pertuzumab + atezolizumab
Open   NCT03595592

Studies gynaecologische oncologie 

Title Tumortype Line of therapy Study information Status Register
DENOSUMAB/DICER: A neoadjuvant phase II study assessing the therapeutic potential of RANK/L signaling inhibition in patients with primary and recurrent squamous carcinoma of the uterine cervix CERVIX new diagnosis or central recurrent invasive
  • new diagnosis of FIGO IB-IVB or central recurrent invasive
  • amenable for biopsy
  • Ca/VitD supplements +/- denosumab 
Open   

EORTC 62113-55115: A phase II study evaluating the role of maintenance therapy with cabozantinib in High Grade Undifferentiated Uterine Sarcoma (HGUS) after stabilization or response to doxorubicin +/- ifosfamide following surgery or in metastatic first line treatment

UTERUS after surgery or local treatment
  • locally advanced HGUS (FIGO III or IV) or residual disease after primary surgery or metastatic HGUS with relapse after local treatment
  • ARM A: doxorubicin +/- ifosfamide with Carbozantinib
  • ARM B: doxorubicin +/- ifosfamide with placebo
Open   NCT01979393

FUCHSIA: An open-label, single arm, prospective, multi-center, tandem two stage designed, phase II study to evaluate the efficacy of Fulvestrant in women with recurrent/metastatic estrogen receptor positive gynecological malignancies

UTERUS, ENDOMETRIUM & OVARIUM 2-3 line hormonal therapy
  • Recurrent or metastatic low grade uterine sarcomas, low grade endometrial carcinomas, sex cord tumors and low grade serous ovarian cancer
  • Estrogen-receptor (ER) positive
  • Hormonal therapy must have lasted for at least 3 months
  • Fulvestrant treatment 
Open  NCT03926936

GCT1015-05/ENGOT-cx8: A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin Monotherapy and in Combination with Other Agents in Subjects with Recurrent or Stage IVB Cervical Cancer

CERVIX depending on cohort: first to 3rd line 
  • Squamous, adenosquamous or adenocarcinoma
  • Arm D (1st line): Tisotumab vedotin + carboplatinum AUC 5 (Q3W)
  • Arm E (1st line): Tisotumab vedotin + pembrolizumab (Q3W)
  • Arm G (2-3rd line): Tisotumab vedotin monotherapy (QW) 
Open

NCT03786081

Studies digestieve oncologie 

Title  Tumortype Line of therapy Study information Status Register
 ASPIRIN: A Randomised, double–blind, placebo-controlled Trial of Aspirin to prevent Recurrence   Colon Cancer  Adjuvant
  • Aspirin versus placebo
  • Ro resection
  • >45year
  • stage II-III
 Open   NCT03464305

SPOTLIGHT: A Double-Blind, Randomized, efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6

Gastric cancer + GEJ 1
  • Claudin 18.2-Positive on central lab
  • HER2-Negative
  • Locally Advanced Unresectable or Metastatic Adenocarcinoma
Open  NCT03504397

CAIRO 5: Treatment Strategies in Colorectal Cancer Patients With Initially Unresectable Liver-only Metastases

Colon cancer + Liver metastasis 1
  • Available KRAS/BRAF status mutation prior randomisation
  • RAS WT: Folfox/folfiri + beva versus pani 
  • RAS MUTANT: Folfox/folfiri versus folfoxiri + beva Liver expert panel will evaluate resectability status
Open  NCT02162563

TOPGEAR: Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma

Resectable Gastric cancer + GEJ Neo-adjuvant
  • Randomisation between preoperative chemo alone versus chemoradiation
  • Chemo: ECF or ECX or EOX or FLOT
  • Pre-op CRT: 5FU or capecitabine 
Open  NCT01924819

DZB-CS-301: A pivotal study of derazantinib in patients with inoperable or advanced intrahepatic cholangiocarcinoma

 

Intrahepatic CholangioCA

2
  • Pre-screening on FGFR2 gene fusions or FGFR2 gene mutations or amplifications who received at least one prior regimen of systemic therapy
Open NCT03230318

BGB-A317-306: Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination with Chemotherapy as First-Line Treatment

Esophageal squamous cell carcinoma

1
  • Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma
  • A treatment-free interval of at least 6 months after definitive treatment
  • Exclusion: unintentional weight loss >5%, uncontrolled diabetes
  • Arm A : Tislelizumab + chemo doublet. Chemo doublet: platinum and 5FU or platinum and paclitaxel
  • Arm B: placebo + chemo doublet. Chemo doublet: platinum and 5FU or platinum and paclitaxel
Open  NCT03783442

TIGeR-PaC: Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab-Paclitaxel following Induction with sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy. 

Unresectable Locally Advanced Pancreatic Cancer

induction
  • Histologically or Cytopathology confirmed pancreatic adenocarcinoma
  • Anatomy suitable for IA delivery of gemcitabine to the intended tumor site
  • Locally advanced, unresectable disease at screening and prior to randomization, as defined by NCCN criteria
  • initial diagnosis within 6 weeks of consent
Open  NCT03257033

Studies hoofd- en halsoncologie

Title Tumortype Line of therapy Study information Status Register
EORTC1206: A randomized phase II study to evaluate the efficacy and safety of chemotherapy (CT) vs. androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic, androgen receptor (AR) expressing, salivary gland cancer (SGCs) Salivary gland  Treatment naïve and pretreated
  • Historical or fresh biopsy required 
  • ARM A treatment naïve triptorelin + bicalutamide or standar chemotherapy
  • ARM B pretreated: triptorelin + bicalutamide
  • Cross-over from Arm A SOC to Arm B possible
Open  NCT01969578
UPSTREAM: A pilot study of personalized biomarker-based treatment strategy or immunotherapy in patients with recurrent/metastatic squamous cell carcinoma of the head and neck

SCCHN: 

  • oral cavity 
  • oropharynx
  • hypopharynx
  • larynx 
>1L, platinum failed 
  • Fresh tumor core biospy, centrally assessed
  • Cohort I2: Pretreated with prior PD(L)1
  • Cohort B1: p16 negative and EGFR amplification/mutation or PTEN high or HER2 amplification/mutation
  • Cohort B2: p16 negative and cetuximab naïve
  • Cohort B3: p16 negative and CCND1 amplification
  • Cohort B4: p16 negative and ‘platinum-sensitive’
  • Cohort B5: p16 positive oropharyngeal cancer
  • Cohort B6: FGFR1/2/3 mRNA overexpression
  • Cohort I2: monalizumab + durvalumab vs. physician's choice
  • Cohort B1 + B2: afatinib vs. physician's choice
  • Cohort B3: palbociclib vs. physician's choice
  • Cohort B4 + B5: Niraparib
  • Cohort B6: rogaratinib
Open  NCT03088059
OpcemISA: A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study of Cemiplimab vs. the Combination of Cemiplimab With ISA101b in the Treatment of Subjects With HPV16-Positive Platin-Resistant Oropharyngeal Cancer (OPC)

SCCHN Oropharynx HPV16+

1-2 L
  • 1st line: tumors express PD-L1
  • 2nd line: progression on or after platinum
  • fresh biopsy, if possible
  • no prior anti-PD(L)1
Open  NCT03669718
COSMIC-311: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy

Thyroid (papillary or follicular)

>1L
  • Up to two prior VEGFR-targeting TKI agents are allowed
  • Previously treated with or deemed ineligible for Iodine-131
  • QTcF < 500 ms
Open  NCT03690388
The AIM-HN: A 2 Cohort, Non-comparative, Pivotal Study Evaluating the Efficacy of Tipifarnib in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS Mutations (AIM-HN)

SCCHN 

  • oral cavity
  • pharynx
  • larynx
  • sinonasal
  • nasopharyngeal
  • unknown primary
>1L
AIM-HN:
  • missense HRAS mutation VAF > 20%
  • platinum failed
  • no curative setting
Open NCT03719690

HN9: Randomized Phase II study of Cisplatin + Radiotherapy vs Durvalumab + Radiotherapy followed by Adjuvant Durvalumab vs Durvalumab + Radiotherapy followed by Adjuvant Tremelimumab and Durvalumab in Intermediate Risk HPV-Positive Locoregionally Advanced Oropharyngeal Squamous Cell Cancer

SCCHN Oropharynx p16+

1L
  • No induction chemotherapy allowed
  • Intermediate risk:
    • - T1-2 N1 (smoking ≥ 10 pack years) 
    • - T3 N0-N1 (smoking ≥ 10 pack years)
    • - T1-3 N2 (any smoking hx) 
  • - Arm A: Cisplatin + RT
  • - Arm B: Durvalumab + RT + adjuvant Durvalumab
  • - Arm C: Durvalumab + RT + adjuvant Durvalumab-Tremelimumab --> closed
Open  NCT03410615

Studies musculoskeletale oncologie (tumoren van de weke delen) 

Title Tumor Type Line of therapy Study information Status Register
rEECur: International Randomised Controlled Trial of Chemotherapy for the Treatment of Recurrent and Primary Refractory Ewing Sarcoma Ewing Sarcoom >1 L
  • Topotecan and Cyclophosphamide (TC)
  • High dose Ifosfamide (IFOS)
Open   

Studies hersenkanker 

Title  Tumor Type Line of therapy Study information Status Register
ADDIT-GLIO: Adjuvant dendritic-cell immunotherapy plus temozolomide following surgery and chemoradiation in patients with newly diagnosed glioblastoma Glioblastoma Adjuvant
  • Estimated to start with chemoradiation ≥ 28 days and ≤ 49 days following surgical resection
  • No Prior radiation or chemotherapy
  • Total or subtotal resection
  • No corticosteroid treatment ≤ 1 week before
  • WT1 mRNA-loaded DC vaccination + CRT (temozolomide)
Open  NCT02649582
ROAM: Radiation versus Observation following surgical resection of Atypical Meningioma: a randomised controlled trial  solitary atypical meningioma Adjuvant
  • Complete resection done
  • Commence radiotherapy between within 12 weeks of surgery
Open   

Studies urologische oncologie 

Title Tumor Type Line of therapy Study information Status Register
PEACE III: A Randomized phase III trial comparing enzalutamide vs. a combination of Ra223 and enzalutamide in asymptomatic or mildly symptomatic castration resistant prostate cancer patients metastatic to bone. Prostate cancer >= 1L
  • ≥ 2 bone metastases
  • Ongoing androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist or antagonist or bilateral orchiectomy
  • Prior docetaxel is permitted under the following conditions: started within 2 months of ADT initiation, given for a maximum of 6 cycles and progression after 6 months of the last dose of docetaxel.
  • ARM A: Enzalutamide
  • ARM B: Ra223 + Enzalutamide
open NCT02194842
CASSIOPE: Prospective noninterventional study of cabozantinib tablets in adults with advanced renal cell carcinoma following prior VEGF targeted therapy Renal Cell Carcinoma >= 2L
  • No previous exposure to cabozantinib prior to inclusion 
Open NCT03419572
AURA: Avelumab as neoadjuvant therapy in subjects with urothelial muscle invasive bladder cancers  Muscle invasive urothelial carcinoma Neo-adjuvant
  • T2, T3 or T4a, Nx, N0, N1 or N2, M0
  • Cisplatin eligible: R1:1 MVAC+Avelumab or Cis-Gem+Avelumab
  • Cisplatin ineligible: R1:1 Paclitaxel-Gem+Avelumab or Avelumab
Open NCT03674424

Studies dermatologische oncologie (huidtumoren) 

Title  Tumor Type Line of therapy Study information Status Register
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. Melanoma 1L
  • Cutaneous melanoma
  • Metastases solely confined within the SN
  • CLND or serial nodal observation according to patient decision
Open  NCT01942603
POINTER: An observational study in patients receiving adjuvant nivolumab therapy for resected melanoma Melanoma Adjuvant
  • Primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection and have no evidence of disease
  • Retrospective and prospective
Open  NCT03771859

Thoraxoncologie 

De dienst thoraxoncologie is een onderdeel van het MOCA (Multidisciplinair Oncologisch Centrum Antwerpen) binnen het UZA. We behandelen patiënten met longkanker, longvlieskanker en thymustumoren. Naast standaard behandelingen bieden we ook behandelingen in studieverband aan. Het gaat hier om fase II en III klinische studies. Het doel van een klinische studie is om te onderzoeken of een nieuwe behandeling veiliger, effectiever en beter is dan huidige behandeling. Voor fase I klinische studies verwijzen we u naar de research unit.

Hoe kan ik de dienst thoraxoncologie bereiken? 

Heb je vragen over de studies binnen de dienst thoraxoncologie? Neem gerust contact met ons op via 03 821 31 07 of via thoraxoncologie [at] uza [dot] be.

Studies thoraxoncologie 

Title Tumor Type Line of therapy Study information Status Register
CheckMate 77T: A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy plus Nivolumab versus Neoadjuvant Chemotherapy plus Placebo, followed by Surgical Resection and Adjuvant Treatment with Nivolumab or Placebo for Participants with Resectable Stage II-IIIB NSCLC NSCLC stage II-IIIB Perioperative
  • Resectable stage IIA (≥ 4cm) to IIIB (T3N2)
  • Tissue to be submitted before randomization 
Open  NCT04025879
EORTC1205 Randomized Phase II Study of Pleurectomy/ Decortication (P/D) Preceded or Followed by Chemotherapy in Patients With Early Stage Malignant Pleural Mesothelioma mesothelioma 1L
  • all subtyes. 
  • cT1-3 N0-2 M0.
  • 1:1 randomisation to P/D followed by adjuvant 3 cycles platinum-pemetrexed versus neoadjuvant 3 cycles platinum-pemetrexed followed by P/D.
Open  NCT02436733
A Randomized, Open-Label Phase II/III Study With Dendritic Cells Loaded With Allogeneic Tumour Cell Lysate (PheraLys) in Subjects With Mesothelioma as Maintenance Treatment (MesoPher) After Chemotherapy (DENIM) mesothelioma 1L
  • early referal (at least during second cycle chemo) required.
  • all sybtypes.
  • 1:1 radomisation MesoPher plus BSC versus BSC alone.
  • no known allergy to shellfish.
  • no history of auto-immune diseases.
Open  NCT03610360
Nintedanib as Maintenance Treatment of Pleural Malignant Mesothelioma (NEMO): a Randomized Double Blinded Phase II Study of the EORTC Lung Cancer Group mesothelioma 1L
  • all subtypes.
  • no progression after 4-6 cycles platinum-based chemotherapy.
  • randomisation within 60 days from last dose of chemotherapy.              
  • nintedanib or placebo oral twice daily
Open  NCT02863055
Single-arm, Multicentre, Phase II Study of Immunotherapy in Patients With Type B3 Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy (NIVOTHYM) thymoma/thymus carcinoma >1L
  • at least one previous line of platinum-based chemotherapy.
  • no history of myasthenia or auto-immune disease.
  • nivolumab q2w.
Hold   NCT03134118
INSIGHT2: A Phase II two-arm study to investigate tepotinib combined with osimertinib in MET amplified, advanced or metastatic NSCLC harboring activating EGFR mutations and having acquired resistance to prior osimertinib therapy. NSCLC 2L
  • EGFR activating mutation

  • MET amplification in TBx, (central or local FISH), or in LBx (central)
  • Prior objective clinical benefit to previous osimertinib 
  • Radiologic disease progression to previous osimertinib
  • Tepotinib + osimertinib or Tepotinib monotherapy
Open NCT03940703
AcceleRET: A Randomized, Open-Label, Phase 3 Study of Pralsetinib vs SOC for First Line Treatment of RET fusion-positive, Metastatic NSCLC  NSCLC stage III-IV 1L
  • Arm A: Pralsetinib PO

  • Arm B: Carboplatin or cisplatin/pemetrexed; Pembrolizumab/carboplatin or cisplatin/pemetrexed; Carboplatin or cisplatin/gemcitabine 

  • Tissue to be submitted (archived/fresh)

  • Crossover possible after central confirmed PD

Open NCT04222972
CARMEN: Randomized, Open Label Phase 3 study of SAR408701 versus Docetaxel in Previously Treated metastatic nonsquamous NSCLC patients with CEACAM5 positive tumors NSCLC >1L
  • CEACAM5 >=2+ (centrally assessed)
  • prior platinum and immune checkpoint inhibitor
  • no previous corneal disorder
  • contact lenses are not permitted
Open NCT04154956
MS200647-0024: Phase Ib/II study of M7824 in combination with chemotherapy in participants with stage IV NSCLC NSCLC 1L/2L
  • Cohort A: 1L non-squamous NSCLC: Cisplatinum/Carboplatinum + Pemetrexed + M7824 Q3W
  • Cohort C: 1L squamous or non-squamous NSCLC: Cisplatinum/Carboplatinum + Gemcitabine + M7824 Q3W --> Closed
  • Cohort D: 2L squamous or non-squamous NSCLC: Docetaxel + M7824 Q3W --> Closed
Open  NCT03840915 
STARTRK-2: Basket study of Entrectinib for patients with tumors that harbor NTRK1/2/3, ROS1 or ALK gene rearrangements. Solid  All
  • Only cohort for NTRK fusions still open
  • Entrectinib PO 600 mg daily
Open NCT02568267
OMO-1: Treatment with OMO-1 alone or in combination with anti-cancer treatments in patients with locally advanced, unresectable or metastatic solid malignancies Solid All
  • Cohort 1: NSCLC exon 14 mutated --> Closed

  • Cohort 2: PD after anti-EGFR with an aquired MET amplification

Open NCT03138083
A phase 1 open-label, dose-escalation study of ABBV-181, as monotherapy and in combination with another anti-cancer therapy in subjects with advanced solid tumors NSCLC <=4L
  • Not more than 1 line containing PD-1 or PDL-1 targeting agent

  • ABBV-181 IV Q4W + Venetoclax PO daily 

Open 

NCT03000257

CodeBreak200: A Phase III, Randomized, Open Label, Active-controlled, Study of AMG510 vs Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC subjects with Mutated KRAS p.G12C

NSCLC

stage IIIb-IV

>=2L
  • KRAS p.G12C mutation centrally confirmed

  • Prior platinum-based doublet and checkpoint inhibitor for advanced or metastatic disease, either as one line or as individual lines

Open

NCT04303780

MCLA-145-CL01: A Phase 1, Open-label, Dose-escalation study of MCLA-145 in participants with advanced or metastatic malignancies 

All solid tumors 

<=4L
  • Dual CD137 + Anti-PD-L1 antibody
  • Prior anti-PD-1 is allowed (max 1 line) 
  • Mandatory pre- and on-treatment biopsy 
  • Specific inclusion criteria for TNBC, melanoma, HNSCC and urothelial carcinoma
Slots

 

NCT03922204