Studies oncologie

Studies oncologie

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University Clinical Research Center Antwerp (UNICCRA)

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 

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

  • Preferred: NSCLC, melanoma, H&N, urothelial cancer or MSI-H/dMMR tumors with PD-L1 >=1%, that already received previous anti-PD-L1 (no slots)
<=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

MATTERS: A mono-centric, first in-human (FIH), safety and preliminary efficacy study of (neo)adjuvant, model-based, whole-body hyperthermia (WBHT) treatment in advanced solid cancer patients or stage IV (TxNxM1) metastatic pancreatic adenocarcinoma patients

Solid - stage IV  All
  • Cohort A2: The highest whole-body hyperthermia duration with acceptable side effects from cohort A1 will be applied to three additional patients with advanced solid cancer, once a week and for 15 days in total
  • Cohort C: Three pancreatic cancer patients will be treated with 3 times 4 hours hyperthermia using the device (Q2W) and in combination with chemotherapy (GEMOX)
Open NCT04467593

EZH-1201: A Phase I, Open-label Multi-dose Pharmacokinetic and Safety Study of Oral Tazemetostat in Subjects with Moderate and Severe Hepatic Impairment with Advanced Malignancies.

All tumortypes with:

  • Moderate hepatic impairment -> slots
  • Severe hepatic impairment -> slots 
Prior SOC 
  • Moderate hepatic impairment: bilirubin from 1.5 to 3 x ULN
  • Severe hepatic impairment: bilirubin >= 3 x ULN
  • Oral tazemetostat
  • Intensive PK sampling
Slots

NCT04241835

TRIDENT-1: A Phase 1/2, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

  • Solid tumors with NTRK rearrangements
  • Solid: maximum 2 prior TKI’s, no limit on prior lines of chemotherapy/immune therapy
  • Oral repotrectinib = novel TKI
  • Different cohorts according to prior TKI and chemo/immune therapy
Open 

NCT03093116

TAPISTRY/BO41932: Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

  • Cohort A: solid tumors with ROS1 fusion, except NSCLC
  • Cohort B: solid tumors with NTRK1/2/3 fusion
  • Cohort C: solid tumors with ALK fusion, except NSCLC
  • Cohort A: prior SOC/none available, prior ROS1 inhibitor is exclusion
  • Cohort B: prior SOC/none available, prior NTRK inhibitor is exclusion
  • Cohort C: prior SOC/none available, prior ALK inhibitor is exclusion
  • Cohort A: entrectinib oral
  • Cohort B: entrectinib oral
  • Cohort C: alectinib oral
Open 

NCT04589845

MCLA-129: 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 tumors

  • Part 1 - Cohort 6: HNSCC, ESCC, GC/GEJ with EGFR amplification or c-MET amplification, NSCLC with EGFR mutations including TKI sensitizing mutation (e.g. 19del and L858R) and/or approved TKI-resistance mutations (e.g. T790M, C797S, L792, L798I, exon 20 insertion), or any activating c-MET mutation/amplification, or c-MET exon 14 exon skipping mutation (no slots)
  • Part 2 - Cohort B: NSCLC cMet exon 14 skipping mutation (screening paused)
  • Cohort 6: prior SOC (>1L) or ineligible/intolerant
  • Cohort B: ≥ 2L, capmatinib and tepotinib resistant or ≥ 2L, TKI naïve
  • MCLA-129 IV Q2W: biospecific monovalent EGFR x cMET antibody
  • Mandatory on-treatment biopsy
  • Intensive PK sampling with overnight hospital stay
  • Cohort B, 6: MCLA-129 monotherapy
Slots 

NCT04868877

GO42144: A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

KRAS G12C mutated
  • CRC
  • NSCLC
  • All other 
Prior SOC or intolerance
  • Oral study medication
  • Intensive PK sampling 
Slots 

NCT04449874

BT5528-100: A Phase I/II study of BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression

  • Urothelial cancer (no slots)
  • Ovarian cancer (no slots)
  • NSCLC (no slots)
  • H&N (no slots)
  • TNBC (no slots)
  • Gastric/upper GI (no slots)
  • Prior SOC 
  • No limit to number of prior treatment regimens
  • Prescreening for EphA2 expression is no longer needed
  • BT5528 IV QW or Q2W
  • Intensive PK sampling during first cycle
Slots

NCT04180371

AMG 20190135: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation

  • Subprotocol F, all cohorts: NSCLC
  • Subprotocol H: 
    • Cohort F: CRC
  • Subprotocol F: 
    • Cohort A1: 1st line (no prior platinum, no prior anti-PD(L)-1)
    • Cohort A2: prior anti-PD(L)-1 mono or prior platinum-based combination (waiting list)
  • Sobprotocol H:
    • Cohort F: no prior therapy
  • Subprotocol F:
    • Cohort A1 and A2: sotorasib + carboplatinum + pemetrexed
  • Subprotocol H:
    • Cohort F: sotorasib + panitumumab + FOLFIRI
  • Mandatory screening and on-treatment biopsy 
Slots NCT04185883

CL1-95012-001: A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors

Solid tumors
  • Prior SOC, no restriction on number
  • Prior anti-PD(L)-1 is allowed
  • PRS-344/S095012 IV Q2W
  • Intensive PK sampling during cycle 1 and 2
Slots NCT05159388

20210023 (AMG193): AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (MTAP) 

  • All solid tumors
  • MTAP-null and/or CDKN2A-null, or lost MTAP expression (local testing)
  • Prior SOC or ineligible
  • AMG193 oral
Slots NCT03564340

20210104 (AMG 552): A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors with FGFR2b Overexpression (FORTITUDE-301) 

  • Head and neck squamous cell carcinoma (cohort closed)
  • Lung adenocarcinoma (cohort closed)
  • Triple-negative breast cancer (cohort closed)
  • Intrahepatic cholangiocarcinoma (cohort closed)
  • Ovarian epithelial cancer (cohort closed)
  • Endometrial cancer (cohort closed)
  • Cervical cancer (cohort closed)
  • Other FGFR2b+ solid tumors (cohort closed)
 
  • TNBC: at least 2 lines
  • Lung adenocarcinoma: at least platinum-based chemotherapy, checkpoint inhibitor and targeted therapy if a targetable mutation is present
  • All other tumor types: at least 1 line
 
  • Bemarituzumab (AMG 552): a monoclonal antibody against FGFR2b, IV Q2W
  • Pre-screening for central IHC FGFR2b overexpression (tissue <10y)
Slots NCT05325866

WP43295: A phase 1a/b open-label study to evaluate safety, pharmacokinetics, and preliminary clinical activity of RO7276389 alone and in combination with cobimetinib in participants with BRAF-V600 mutation-positive advanced solid tumor or BRAF-V600 mutation-positive melanoma with central nervous system metastases

  • Part 1: Metastatic or locally advanced solid tumors with BRAF-V600 mutation
  • Part 2: Cutaneous melanoma with asymptomatic brain metastases (not yet open)
Prior SOC
  • RO7276389: a potent RAF inhibitor targeting mutant BRAF V600E/K protein
  • Part 1a, part 2 cohorts 1 & 2: monotherapy RO7276389
  • Part 1b, part 2 cohorts 3 & 4: combination RO7276389 with cobimetinib
Slots ISRCTN13713551

61186372GIC2002 (ORIGAMI-1): A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants with Advanced or Metastatic Colorectal Cancer

CRC with KRAS/NRAS/BRAF/EGFR/HER2 wild type
  • Cohort D: left or right sided, no prior oxaliplatin or anti-EGFR therapy 
  • Cohort E: left or right sided, no prior irinotecan or anti-EGFR therapy (screening paused)
  • Cohort D, E: 2L
  • Amivantamab: an antibody directed against EGF and MET receptors
  • Cohort D: amivantamab + mFOLFOX6
  • Cohort E: amivantamab + FOLFIRI
  • Mandatory screening biopsy
Slots NCT05379595

20200469: A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects with Extensive Stage Small Cell Lung Cancer

  • SCLC
1L
  • Part 1, 2, 3: AMG757 (tarlatamab) + carboplatin/etoposide + atezolizumab
  • Part 5: AMG757 (tarlatamab) + atezolizumab 
Slots NCT05361395

MK6482-016: An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Multiple Solid Tumors

  • Cohort A: HCC (closed)
  • Cohort E: endometrium (closed)
  • Cohort F: ESCC (open)
  • Cohort A: 1L
  • Cohort E: 1L, non-MSI-H
  • Cohort F: 2L, IO naïve
  • Pembrolizumab Q6W + lenvatinib + belzutifan
  • Belzutifan: inhibitor of HIF-2α
  • Lenvatinib: inhibitor of VEGFR1-3
Slots NCT04976634

KBA1412-101: A Phase I, first-in-human, multicenter, open-label, dose escalation followed by an expansion phase clinical study of KBA1412 given as monotherapy or in combination with pembrolizumab in adults with advanced solid malignant tumors 

  • Part A: all solid tumors
  • Part B, C: melanoma, ovarian cancer, gastric cancer, CRC
  • Part A: All
  • Part B, C: Prior PD(-L)1 therapy, if this is SOC
  • Part A, B: KBA1412 monotherapy
  • Part C: KBA1412 + pembrolizumab
  • KBA1412: anti-CD9 human monoclonal antibody, IV
Slots NCT05501821

DAY101-102: A Phase 1b/2, Open Label Study of DAY101 Monotherapy or Combination with Other Therapies for Patients with Recurrent, Progressive, or Refractory Solid Tumors Harboring MAPK Pathway Aberrations

All solid tumors with:
  • BRAF fusion with intact kinase domain except SEPT3-BRAF
  • CRAF/RAF1 fusion
  • CRAF/RAF1 amplification
Prior SOC or intolerant
  • DAY101 monotherapy
  • DAY101: oral type II pan-RAF kinase inhibitor
  • Archival tissue <1y old
Slots NCT04985604

DO2.22.01: A Phase 1 Study to Determine the Safety, and Pharmacokinetics of the Selective MET kinase Inhibitor, DO-2 in Patients With Advanced or Refractory Solid Tumours

All solid tumors with:
  • MET activating mutation
  • MET amplification >10 GCN
  • Hereditary renal papillary cancer
  • Treatment naive with no current options
  • Prior SOC (prior MET inhibitor without PD is allowed)
  • Intolerance
  • DO-2: Oral MET kinase inhibitor
Slots  

1403-0011 (Brightline-2): A Phase IIa/IIb, open-label, single-arm, multi-centre trial of BI 907828 for treatment of patients with locally advanced/metastatic, MDM2 amplified, TP53 wild-type biliary tract adenocarcinoma, pancreatic ductal adenocarcinoma, or other selected solid tumours

MDM2 amplified, TP53 wild-type solid tumours:
  • Cohort 1: biliary tract adenocarcinoma (screening paused) 
  • Cohort 2: pancreatic ductal adenocarcinoma (closed)
  • Cohort 3: lung adenocarcinoma
  • Cohort 4: urothelial bladder cancer
  • Cohort 1: prior SOC or ineligible
  • Cohort 2-4: prior SOC
  • BI 907828 monotherapy
  • BI 907828: oral MDM2-p53 antagonist, Q3W, 45 mg 
  • MDM2 amplification and TP53 wild type on local testing
Open NCT05512377

INCA 32459-101: A Phase 1, Open-Label, Multicenter Study of INCA32459 in Participants With Select Advanced Malignancies

Part 1: dose escalation
  • Melanoma
  • NSCLC
  • Malignant pleural mesothelioma
  • HPV–positive SCCHN, anal carcinoma, or cervical cancer
  • Hepatocellular carcinoma (HCC)
  • Esophageal carcinoma
  • Renal cell carcinoma
  • Hormone receptor–positive/HER-2 negative breast cancer
  • Triple-negative breast cancer (TNBC)
  • Select B-cell lymphomas, including: DLBCL, PMBCL
  • MSI-high/dMMR solid tumors
  • Small cell lung cancer (SCLC)
  • Urothelial carcinoma
  • Nasopharyngeal carcinoma
  • DNA polymerase epsilon mutated solid tumors (P286R and V411L)
  • Clear cell ovarian or endometrial carcinoma
  • Other tumor types with medical monitor approval
 
Part 2: dose expansion
  • Melanoma (excluded: uveal melanoma)
  • SCCHN (CPS >= 1) (excluded: salivary gland, nasopharynx)

Part 1: prior SOC

Part 2: <= 2L

  • INCA32459 monotherapy
  • INCA32459: LAG-3 x PD-1 bispecific antibody, IV, Q3W
  • Part 2: mandatory fresh biopsy at screening and on treatment
Slots NCT05577182

1456-0001: Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with ezabenlimab in patients with advanced or metastatic solid tumors

All solid tumors with accessible tumor lesions
Prior SOC or ineligible
  • BI 1831169 monotherapy
  • BI 1831169: virus immunotherapy
  • Arm A: Intratumoral administration
  • Arm B: Intravenous administration (not yet open)
  • Arm C: IT + IV (not yet open)
  • Very limited slots
Slots NCT05155332

GO43860: A Phase IA/IB, open label, multicenter, dose-escalation study to evaluate the safety, pharmacokinetics, and activity of RO7502175 as a single agent and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors

Selected solid tumors with PD-L1 >=1% (>=10% for esophageal)

Phase 1A: monotherapy

  • Cohort A: NSCLC, HNSCC, cutaneous melanoma (on hold)
  • Cohort B: triple negative breast cancer (TNBC), urothelial cancer, esophageal, gastric, gastro-esophageal junction, cervical, clear cell renal cell carcinoma, HCC (not yet open)
Phase 1B: combination therapy
  • Phase 1B: CPI-experienced NSCLC (no slots)
  • Phase 1B: CPI-experienced HNSCC
Prior SOC
  • Phase 1A: RO7502175 monotherapy
  • Phase 1B: RO7502175 + atezolizumab
  • RO7502175: Anti-CCR8 monoclonal antibody, IV, Q3W 
  • Mandatory serial biopsy
Slots NCT05581004

PYX-201-101: A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Participants with Advanced Solid Tumors

 

  • Part 1 dose escalation: NSCLC, HNSCC, ovarian, breast cancer, thyroid, pancreatic ductal adenocarcinoma (PDAC), soft tissue sarcoma, HCC, kidney cancer (waiting list)

 

Prior SOC
  • PYX-201: Ab-drug conjugate (anti-EDB+fibronection linked to auristatin), IV, Q3W
  • Mandatory on-treatment biopsy + archival tissue <3y old
Slots NCT05720117

IMC-F106C-101: A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers

HLA-A*02:01-positive and PRAME-positive solid tumors
 
Currently enrolling:
  • Cutaneous melanoma (CM)
  • Uterine/endometrium carcinoma (EC)
  • NSCLC
Pre-screening only allowed for: 
  • cutaneous melanoma (CM)
  • Uterine/endometrium carcinoma (EC)
  • NSCLC
  • Serous ovarian carcinoma (SOC)
  • Urothelial carcinoma
  • Merkel cell carcinoma
  • TNBC
  • SCLC
 
Will be eligible with new amendment:
  • Serous ovarian carcinoma (SOC)
  • TNBC (Triple negative breast cancer)
  • SCLC
  • Urothelial carcinoma (platinum ineligible)
  • Merkel cell carcinoma
  • Myxoid liposarcoma
  • Synovial sarcoma
  • Round cell liposarcoma
  • Germ cell tumor (seminoma, spermatocytic tumor, choriocarcinoma)
  • Salivary gland adenoid cystic carcinoma
  • Basal cell skin carcinoma
  • Thymic carcinoma
  • Peripheral nerve sheet tumor
  • Skin neuroendocrine carcinoma
  • Uveal melanoma
  • Mucosal melanoma
Prior SOC or intolerant/ineligible
  • IMC-F106C: monoclonal T cell receptor fused to an antibody against CD3
  • Arm A: IMC-F106C monotherapy
  • Arm B: IMC-F106C + pembrolizumab
  • Arm C: IMC-F106C + chemo (PLD)
  • IMC-F106C: IV, QW, intrapatient dose escalation
  • Pre-screening for HLA: mandatory for all tumor types
  • Pre-screening for PRAME: not mandatory for CM, EC, NSCLC, SCLC, SOC, TNBC and UM, only retrospective testing requested. Mandatory PRAME pre-screening for all other tumor types. 
Open NCT04262466

XB002-101 (JEWEL101): A dose-escalation and expansion study of the safety and pharmacokinetics of XB002 as single-agent and combination therapy in subjects with inoperable locally advanced or metastatic solid tumors

All cohorts temporarily on hold
  • ESCC
  • Urothelial cancer
  • NSCLC (waiting list)
  • mCR prostate cancer (waiting list)
  • TNBC (triple negative breast cancer) (waiting list)
  • Epithelial ovarian carcinoma
  • HNSCC
  • Pancreatic cancer (waiting list)
  • Cervical cancer
  • HR+ breast cancer
  • ESCC: <= 2L
  • Urothelial cancer: <= 3L
  • NSCLC: <= 3L
  • mCR prostate cancer: min 1 novel hormonal therapy
  • TNBC: >1L and <= 3L
  • Epithelial ovarian carcinoma: <= 3L
  • HNSCC: <= 3L
  • Pancreatic cancer: >1L and <= 2L
  • Cervical cancer: <= 2L
  • HR+ breast cancer: >1L and <= 2L (no limit on endocrine therapy)
  • XB002: Ab-drug conjugate (anti-TF antibody linked to a novel N-acyl sulfonamide auristatin), IV, Q3W
  • XB002 monotherapy
  • TF expression test on archival tissue in local lab, only required for the other solid tumors cohort
  • Archival tissue <2y (otherwise fresh biopsy can be used)
On hold NCT04925284

JK08.1.01: A Phase 1/2, Multicenter, Open Label, Dose Escalation & Dose Expansion Study of JK08, an IL-15 Antibody Fusion Protein Targeting CTLA-4, in Patients with Unresectable Locally Advanced or Metastatic Cancer

Dose escalation (currently open):
  • Non-small cell lung cancer (NSCLC)
  • Small cell lung cancer (SCLC)
  • Cutaneous melanoma
  • Clear cell or papillary renal cell carcinoma (RCC)
  • Urothelial cancer (UC)
  • Head and neck squamous cell cancer (HNSCC)
  • Luminal B (ER+, PR-, any HER2 status) or triple-negative breast cancer (TNBC)
  • Gastric or gastro-esophageal adenocarcinoma (GC/GEJ)
  • Esophageal squamous cell cancer (ESCC)
  • Skin squamous cell carcinoma (SCC)
  • Pancreatic adenocarcinoma
  • Hepatocellular carcinoma (HCC) (Childs-Pugh A or B7 only)
  • Colorectal adenocarcinoma (CRC)
  • Epithelial ovarian cancer
  • Cervical cancer
  • Endometrial adenocarcinoma
  • Thyroid cancer (follicular or papillary)
Prior SOC or intolerant/ineligible
  • JK08: an IL-15 antibody fusion protein targeting CTLA-4, SC, QW
  • JK08 monotherapy
  • Pre- and on treatment biopsy for backfill patients
Slots NCT05620134

GCT1047-01: First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1047 in subjects with malignant solid tumors

 
  • PROC (platinum resistant ovarian cancer) (on hold)
  • TNBC (triple negative breast cancer) (waiting list)
  • EC (endometrium cancer)
  • PROC (1-3 prior lines of systemic therapy)
  • TNBC (2-4 prior lines of chemotherapy, IO will not be counted)
  • EC (max 2 prior lines)
  • GEN1047: bispecific antibody for B7H4 + CD3
  • GEN1047, IV, QW in C1-4, Q3W from cycle 5
  • Mandatory fresh biopsy (except when not medically feasible)
Open NCT05180474

Bayer 21820: First-in-human dose-escalation and expansion study to evaluate the safety, tolerability, and pharmacokinetics of the anti-CCR8 antibody BAY 3375968 as monotherapy and in combination with pembrolizumab in participants with selected advanced solid tumors

Dose escalation (currently open):
  • Arm 1A: NSCLC, TNBC, HNSCC, melanoma, other types of skin cancer
  • Arm 1B: all solid tumors, except for primary CNS tumors
Prior SOC
  • BAY3375968: Anti-CCR8 antibody, IV, QW
  • Arm 1A: BAY3375968 monotherapy 
  • Arm 1B: BAY3375968 + pembrolizumab, Q3W, IV
  • Arm 1A: mandatory biopsy
  • Arm 1B: no mandatory biopsy
Slots NCT05537740

OPTIMIZE-1: An open-label phase 1b/2 study assessing the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma

Pancreatic ductal adenocarcinoma (PDAC)
1L
  • mFOLFIRINOX Q2W IV + mitazalimab Q2W IV 
  • Mitazalimab: anti-CD40 antibody
  • Archival tissue <28d old or fresh biopsy
Slots NCT04888312

Studies borstkanker 

Title Tumortype Line of therapy Study information Status Register
CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy with Camizestrant (AZD9833) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients with ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence HER2- / HR+  Adjuvant
  • AZD9833 vs standard mono ET
  • Min 2 years on adjuvant ET, max. 5 years (+/- CDK4/6 inhibitor)
  • Bilateral en multifocal/centric allowed if all lesions are HER2- and ER/PR+
  • Tumor tissue required (wait for receipt, but not results)
Open NCT05774951
TROPION-Breast03: Randomized, Open-label Phase 3 study of Datopotamab Deruxtecan with or without Durvalumab vs Investigator's Choice therapy in patients with stage I-III TNBC TNBC (no BRCA1 or BRCA2 mutation) Adjuvant
  • Dato-DXd + Durva vs Dato-DXd vs Investigator Choice
  • If post-operative radiation: interval <6weeks between end date radiation and randomisation
  • If no radiation: interval <16weeks between date breast surgery and randomisation
  • Patient must have residual invasive disease and/or axillary lymph nodes after surgery
Open NCT05629585

TACTIVE-U/C4891024: An interventional safety and efficacy Phase 1b/2, open-label umbrella study to investigate tolerability, PK, and antitumor activity of ARV-471 (PF-07850327), an oral Proteolysis Targeting Chimera, in combination with other anticancer treatments in participants aged 18 years and over with ER+ advanced or metastatic breast cancer.

HER2-/ER+ 1-3L
  • Max. 2 prior lines in m+ setting:
  • <= 1 prior chemo
  • <= 2 prior ET
  • 1 prior CDK4/6 required (adjuvant allowed)
  • No prior experimental ET (SERD, pROTAC, CERAN, SERCA) or elacestrant
Open NCT05548127

ELECTRA/ELA-0121: An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination with Abemaciclib in Women and Men with Brain Metastasis from ER Positive, HER-2 Negative Breast Cancer

HER2-/ER+ 2-3L
  • prior therapy in the m+ setting :
    • min. 1 ET
    • max. 2 chemo regimens
    • max. 2 prior prior CDK 4/6 inhibitors, not abemaciclib
Open NCT05386108

C4891001 / Veritac-2: A Phase 3, Randomized, Open-Label, Multicenter Trial Of Arv-471 (Pf-07850327) Vs Fulvestrant In Participants With Estrogen Receptor-Positive, Her2-Negative Advanced Breast Cancer Whose Disease Progressed After Prior Endocrine Based Treatment For Advanced Disease.

 

HER2-/ER+ 2-3L
  • 1 prior line of CDK4/6 + ET in m+ setting
  • Max. 1L of ET in m+ setting in addition to CDK4/6 regimen.
  • Last ET must have been given for ≥ 6 months without PD.
  • A neoadjuvant/adjuvant treatment is counted as a line for m+ setting if PD on or within 12 months after last dose.
  • No prior chemotherapy for advanced/metastatic disease.
Open NCT05654623

VIKTORIA-1/CELC-G-301: A Phase 3, Open-Label, Randomized, Three-Arm Study of Gedatolisib Plus Palbociclib plus Fulvestrant and Gedatolisib Plus Fulvestrant in HR-Positive, HER2-Negative Advanced or Metastatic Breast Cancer Patients Previously Treated with a CDK4/6 Inhibitor

HER2-/ER+ 2-3L
  • Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidal aromatase inhibitor
  • No prior treatment with fulvestrant, PI3K inhibitor, AKT inhibitor, mTOR inhibitor
  • No prior chemotherapy for advanced disease
  • Max. 2 prior lines of ET
Open NCT05501886

INAVO121/WO43919: a Phase III, multicenter, randomized, open-label, global study designed to compare the efficacy and safety of inavolisib plus fulvestrant versus alpelisib plus fulvestrant in patients with HR +/HER2 - , PIK3CA-mutated LA/mBC, who progressed during or after CDK4/6i-plus endocrine therapy.

HER2-/HR+ 2-3L
  • PIK3CA mutation (can be centrally tested on blood, see protocol for specifications)
  • PD during or after CDK4/6 + ET
  • Max. 2 prior systemic therapies in m+ setting (1L chemo allowed)
  • No prior treatment with: PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the  PI3K/-AKT/-mTOR pathway
Open NCT05646862

AIPAC-003: A randomized, double-blind, placebo-controlled Phase 3 trial testing eftilagimod alpha (soluble LAG-3) in HER2-neg/low metastatic breast cancer patients receiving paclitaxel, following an open-label dose optimization

TNBC and HER2-/HR+  1L chemo
  • Paclitaxel + eftilagimod alpha
  • HR+ patients must be ET resistant
  • Number of ET does not matter
  • TNBC must not be eligible to anti-PD-1 based therapy 
  • No prior chemo for MBC 
Open NCT05747794

Studies gynaecologische oncologie 

Title Tumortype Line of therapy Study information Status Register

R4018-ONC-1721: Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer 

Ovarian carcinoma of epithelial origin
  • At least 1 prior platinum line for which progression
  • REGN4018 IV QW as monotherapy OR REGN4018 IV QW + cemiplimab IV Q3W
  • Mandatory screening biopsy
  • Very intensive study with mandatory hospitalization after the first 3-6 REGN4018 administrations (depending on cohort)
  • Very intensive PK sampling
Slots NCT03564340

MK4830-002: Randomized, Phase 2 Study of Pembrolizumab And Chemotherapy With or Without MK-4830 as Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer

Ovarian: stage III or IV HGSOC
  • New diagnosis
  • No prior therapy
  • Neoadj: 3 cycles of carbo/paclitaxel + pembro (+ MK4830)
  • Interval debulking
  • Adj: 3 cycles of carbo/paclitaxel + pembro (+ MK4830)
Open NCT05446870

(IN)CIP-S25470: Cancer in Pregnancy 

Cancer during pregnancy
and in first 5 years after delivery
  • All 
  • All patients with cancer diagnosis/cancer treatment during pregnancy
  • Gather pregnancy-, malignancy- and placenta-related data
  • Multiple study (sub)parts
 
Open NCT00330447

GE-CIP-S62388: Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy

Cancer during pregnancy (any type and stage)
  • All
  • Extension of CIP-study (S25470) 
  • Patients with histological proven cancer during pregnancy and ongoing pregnancy 
  • Collection cord blood, meconium and neonatal buccal cells at birth
 
Open NCT04125446

Studies digestieve oncologie 

Title  Tumortype Line of therapy Study information Status Register

Neoadjuvant Regorafenib in Combination With Nivolumab and Short-course Radiotherapy in Intermediate-risk, Stage II-III Rectal Cancer 

REGINA

Rectal cancer Neo-adjuvant
  • Regorafenib + nivolumab + short-course radiotherapy
  • Intermediate-risk stage II-III 
On hold

NCT04503694

Phase 3 study of perioperative Dostarlimab in participants with untreated T4N0 or stage III dMMR/MSI-H resectable colon cancer.

219606 / AZUR-2

colon cancer Neo-adj/adj
  • Dostarlimab Q3W -IV- 4 cycle > surgery > Dostarlimab Q6W – 6 cycli > FU
  • Vs Surgery > SOC capox or folfox > FU
  • Randomization 2:1
  • Untreated T4N0 or stage III dMMR/MSI-H colon cancer
Expected  

A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected Pancreatic Ductal Adenocarcinoma 

GO44479 - IMCODE003

resectable PDAC Neo-adj/adj
  • Arm A: Autogene cevumeran IV + atezolizumab IV Q4W + mFolfirinox
  • Arm B: mFolfirinox 
  • Randomization 1:1
  • Screening occurs in 2 parts:
  • Part A before surgery to collect blood and tissue – at least 5 neoepitopes must be identified
  • Part B: Main ICF and further screening within 28 and 14 days of enrolment
  • Histological confirmed diagnosis of PDAC
  • pTNM:  T1-T3, N0-N2, M0 per AJCC 8th ed
  • R0 or R1 resection of PDAC
  • Absence of spleen; distal pancreatectomy with splenectomy is exclusionary
Expected  

A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer

AT148006

ASPEN-06

 
Advanced gastric or gastroesophageal junction 2L-3L
  • phase 2: ALX 148 + Trastuzumab + Ramicirumab+ Paclitaxel vs Trastuzumab  +Ramicirumab + Paclitaxel 
  • phase 3:  ALX 148 + Trastuzumab + Ramicirumab+ Paclitaxel vs Ramicirumab + Paclitaxel
  • HER2 positive tumor
  • Progression on or after prior HER2 directed agent + 5FU or platinum containing regimen
Closed

NCT05002127

Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression 

AMGEN 20210096 FORTITUDE-101

Advanced gastric or gastroesophageal junction  1L
  • Bemarituzumab versus placebo +chemotherapy  (folfox 6)
  • FGRF2b central testing by IHC
  • HER2 positive tumor is exclusion if known
Open 

NCT05052801

Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen 

DS8201-A-U306

DESTINY-gastric-04

 
Advanced gastric or gastroesophageal junction 2L
  • Trastuzumab Deruxtecan versus Ramicirumab+Paclitaxel
  • Centrally confirmed HER2- positive tumor (IHC3+ or IHC 2+)
  • Progression on or after first line Trastuzumab-containing regimen
Open

NCT04704934

Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation 

MRTX849 

KRYSTAL-10

 
Advanced colorectal cancer  2L
  • MRTX 849 + cetuximab versus chemotherapy
  • KRAS G12C mutation
  • Disease progression on 1st line
Closed

NCT04793958

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer

AMGEN 20210098 - FORTITUDE-102

Unresectable (locally advanced or metastatic) gastric of GEJ adenocarcinoma 1st line 
  • Bemarituzumab + mFOLOFOX6 + Nivolumab Versus Placebo + mFOLFOX6 + Nivolumab
  • No prior treatment for metastatic or unresectable disease except for a maximum of 1 dose of mFOLFOX6 with or without nivolumab. 
  • FGFR2b overexpression positive as determined by centrally performed immunohistochemistry (IHC) testing
  • Prior treatment with (FGF—FGFR pathway is exclusion
Open

NCT05111626

FOLICOLOR Trial: Following therapy response through Liquid Biopsy in metastatic colorectal cancer patients

(unresectable) Metastatic colorectal Cancer 1L
(2-3L if recurrence)
  • Randomized trial: Therapy response CT-scan VS. Liquid Biopsy
  • Starting FOLFOX/FOLFIRI +/- EGFR OR +/- VEGF
  • Starting Pembrolizumab (MSI high)
  • RAS/BRAF mutant/WT or MSI high
  • ECOG 0-2
  • > 18 years
Open NCT04735900

NALPAC:

A non-comparative randomized phase 2 study, evaluating the efficacy of 5-FU + Naliri and 5-FU + Nalirinox for metastatic pandreatic ductal adenocarcinoma

 
Metastatic PDAC 2L
  • Randomized trial 1:1: 
  • Arm A (standard of care arm): nal-IRI + 5-FU/LV (NALIRI)
  • Arm B (experimental arm): nal-IRI + 5-FU/LV + OxaliplatinECOG 0-2
  • Progression After 1L gemcitabine mono OR gemcitabine/abraxane
Open  NCT05472259

Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, Combined with Chemotherapy, in Patients with advanced cancers.

ACTUATE  1801

Metastatic PDAC 1L
  • nab-Paclitaxel + gemcitabine IV d1,8,15/28d cycle + 9-ING-41 QW IV vs nab-Paclitaxel + gemcitabine alone
  • Open-label
  • Randomized 2:1
  • Measurable disease per Recist 1.1
  • Pathological or cytological confirmed metastatic pancreatic cancer
Closed NCT03678883

COLIPAN: 

Collection of Liquid Biopsies in Pancancer patients

 
Colon adenoCa, Rectum adenoCa, Pancreas adenoCa, Hepatocellulair Ca, slokdarm plaveiselcel 1L
 
  • Liquid Biopsy collection new diagnoses 
  • No NET-tumours
Open   

A Randomised, double–blind, placebo-controlled Trial of Aspirin to prevent Recurrence

 

ASPIRIN

 
Colon Cancer Adjuvant
  • Aspirin versus placebo
  • R0 resection
  • >45year
  • Stage II-III
Closed for randomization NCT03464305

Open-label, phase 2 trial of Botensilimab as monotherapy and in combination with Balstilimab or investigator’s choice SOC (regorafenib or trifluridine and tipiracil) for refractory metatstatic colorectal cancer.

 

PROTOCOL C-800-25

Agenus 

Metastatic Colorectal Cancer >2L
  • Arm A + B: Botensilimab (IV) + balstilimab (IV)
  • Arm C + D: Botensilimab (IV)
  • Arm E: regorafenib (PO) or trifluridine/tipiracil (PO) - PI choice
  • Progressed or intolerance on SOC
  • Measurable disease per RECIST 1.1
  • Tissue to be submitted

Exclusion:

  • MSI-H/dMMR tumor
  • Liver metastasis > unless definitively treated at least 6 months prior enrolment
  • prior treatment with regorafenib or trifluridine/tipiracil
  • Ascites requiring frequent paracenteses
Hold NCT05608044

A randomized Phase 2 Study of ompenaclid versus placebo in combination with FOLFIRI plus bevacizumab in patients with previously treated RAS mutant advanced or mCRC

RGX 202-002

Advanced or metastatic colorectal cancer 2L
  • Ompenaclid versus placebo (PO) BID + folfiri + bevacizumab (IV) Q2W
  • Randomization 1:1
  • RAS mutated 
  • Progression after receiving 1 oxaliplatin containing regimen
  • dMMR/MSI-H CRC must also have received prior pembrolizumab or an FDA/EU approved PD-1/PD-L1 inhibitor
  • Measurable disease per Recist 1.1
Open NCT05983367

Personalized multimodal treatment for resectable esophageal cancer by detecting minimal residual disease using circulating tumor DNA: a multicentric prospective study

New diagnosis of esophageal cancer, pathologically confirmed squamous cell carcinoma (ESCC) or adenocarcinoma (EAC)

Group 1: Patients undertaking primary resection (surgery or endoscopic) with no neoadjuvant chemotherapy or chemoradiation.

Group 2: Patients receiving neoadjuvant chemoradiotherapy, followed by resection and observation (no adjuvant immunotherapy). A subgroup of patients will undertake adjuvant immunotherapy and will constitute Group

Group 3: Patients undertaking neoadjuvant chemoradiotherapy, resection and adjuvant immunotherapy.

  • Sponsor UZ Leuven. Prospective collection of liquid biopsies (additional tubes at time of routine lab assessments), retrospective retrieval of leftover tissue samples, and collection of standard clinical data in an electronic database are study-related procedures.
Open  NCT05704530

SARTOX

Gastro-Intestinal Tumour

Not applicable

  • Association between sarcopenia and chemotoxicity in older patients with gastro-intestinal tumors
Open  

STEREOPAC

Pancreatic Adenocarcinoma (Borderline resectable)

Not applicable

  • Preoperative treatment with mFOLFIRINOX (or Gem-Nab-P) +/- isotoxic high-dose Stereotactic Body Radiation Therapy (iHD-SBRT) for borderline resectable pancreatic adenocarcinoma
  • Sponsor: Erasme University Hospital
Open NCT05083247

A study of Tucatinib + Trastuzimab + mFOLFOX6 versus standard of care treatment in 1ste line HER2+ mCRC.

 

SGNTUC-029 / MOUNTAINEER-03

 
mCRC

1st line

  • Tucatinib +Trastuzumab+mFOLFOX6
    vs
  • mFOLFOX6 +/- Bevacizumab or Cetuximab
  • Tissue available: max 35 days old prior start of study
  • HER2+ disease (IHC3+ or IHC2+/ISH+) > analyzed in a central lab 
  • RAS WT  > analyzed local or central
  • Measurable disease per RECIST1.1 criteria
  • Prior anti-HER2 therapy is exclusion
  • Adjuvant therapy is allowed if completed > 6 months prior enrollment
Open NCT05253651

A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic HCC.

IMbrave152 / CO44668

Advanced or metastatic HCC

1L

  • Arm A: Atezolizumab + bevacizumab + Tiragolumab - IV Q3W
  • Arm B: Atezolizumab + bevacizumab + placebo - IV Q3W
  • Randomization 1:1
  • Measurable disease per Recist 1.1
  • Child-Pugh A < 7 d of randomization
Open NCT05904886

Phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety Rego-Pembro versus TACE or TARE for the first-line treatment of HCC 

TRIO 041 / REPLACE studie

HCC

1ste line

  • Regorafenib PO + pembrolizumab IV Q6W vs TACE or TARE
  • Randomization 1:1
  • Intermediate-stage HCC/beyond up-to-seven criteria / Child-Pugh Class A
  • No contraindication to intra-arterial treatment
  • Measurable disease per Recist 1.1
  • No prior therapy for HCC
  • Fibrolamellar HCC, sarcomatoid HCC or mixed HCC / cholangiocarcinoma / clinically significant ascites are excluded
Expected  

A study of on-treatment ctDNA changes in chemo-refractory colorectal cancer patients

COPERNIC

 

Advanced colorectal cancer

>= 3L

  • Collection of blood samples at pre-defined time points for ctDNA testing.
  • Collection of archived tumour tissue to perform genomic characterisation
Open

NCT05487248

A Trial to Evaluate the Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma

BALLAD 

 

Stage I – III small bowel adenocarcinoma

1L

  • Group 1: adjuvant chemotherapy versus observation
  • Group 2: monotherapy (5-FU/FA or capecitabin) versus combined therapy (5FU/FA orcapecitabin +oxaliplatin)
Open

 

Efficacy and safety of SCRT versus TNT in older patients with locally advanced rectal cancer

SHAPERS

Rectal Cancer

1L

  • Stage III or high-risk stage II rectal cancer, ≥ 70 years
  • Randomisation (1:1) to short-course radiotherapy (SCRT) or total neoadjuvant therapy (TNT)
  • QOL-questionnaires
Open

NCT06052332

A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy versus Standard of Care in Participants with Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer 

AZUR-2
Untreated T4N0M0 or Stage III dMMR/MSI-H Resectable Colon Cancer

1L

  • Randomized trial with Dostarlimab mono VS adjuvant FOLFOX or CAPEOX or Watch and Wait
  • Dostarlimab 500mg Q3W for 4 cycles followed by surgery and additional 6 cycles of dostarlimab 1000mg Q6W

OR

  • Surgery followed by SOC (FOLFOX or CAPEOX or WATCH and Wait)
  • Tumor with dMMR or MSI-H
Open

NCT05855200

WT IL15 DC vaccination Trial: First-in-human interleukin-15-transpresenting Wilms’ tumor protein 1-targeting autologous dendritic cell vaccination in cancer patients

Solid tumors - pancreas preferred

>= 2L; PD on last therapy not needed

  • Vaccination with 6 IL-15-Transpresenting WT1-targeted DC vaccines after leukapheresis
With waiting list

NCT05964361

 

Studies neuro-endocriene tumoren (NET) 

Title Tumor Type Line of therapy Study information Status Register

A Trial to Assess Efficacy and Safety of Octreotide (CAM2029) Subcutaneous Depot in Patients With GEP-NET                                                                                                       

 HS-19-657 SORENTO

GEP-NET                          

2L                                     

  • CAM2029 versus octreotide LAR or lanreotide ATG
  • Well-differentiated NET of GEP progession during treatment (including SSAs)                                                             

Closed   

         

 NCT05050942
 Liquid-NET 2.0: A prospective, multicentric, proof-of-concept study to evaluate the value of circulating tumour DNA in follow-up of patients with an advanced gastroenteropancreatic or lung neuroendocrine tumour under everolimus ± somatostatin analogues  Metastasized neuroendocrine tumor of gastrointestinal, pancreatic or lung origin  >=2L
  •  Everolimus naive patients who start treatment with everolimus +- somatostatin analogues
  • Inclusion is possible after proven progressive disease on scans
  • Blood sampling

  

 
Open 

 

Quali-NET: Patient-reported outcomes in neuroendocrine neoplasms: a prospective quality of life and quality of care study within NETwerk All neuroendocrine neoplasms All
  • QoL Questionnaires twice a yea
Open   NCT05268783 
Collect-NET 2.0 by BE-FORCE: Collection of liquid biopsy samples of patients with neuroendocrine neoplasms All neuroendocrine neoplasms All
  • Blood sampling
Open  NA
DNET registry: a Belgian prospective, national, web-based registry of digestive neuroendocrine tumors All gastrointestinal neuroendocrine neoplasmsNENs All
  • Data collection
Open NA
SAUNA trial: Continuing Somatostatin Analogues Upon progression in Neuroendocrine tumour pAtients GEP NET 2L
  • Patients with grade 1‒2 GEP NET with disease progression on 1L SSA
  • Randomised: continuation or withdrawal from SSA at start of 2L therapy (PRRT or targeted therapy
  • Questionnaires
Open NCT05701241

 

Studies hoofd- en halsoncologie

Title Tumortype Line of therapy Study information Status Register

JZJB/LIBRETTO-531: A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Cabozantinib or Vandetanib in Patients with Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer 

Thyroid

1L
  • Crossover possible
  • Patients from 12 yo
On hold NCT04211337 

ELEVATE: A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

SCCHN:

  • oropharynx
  • oral cavity
  • hypopharynx
  • larynx
1L
  • metastatic or unresectable, locally recurrent
  • Phase 2 cohort 1: 1L
    • arm A: magrolimab + pembrolizumab + platinum + 5-FU
    • arm B: pembrolizumab + platinum + 5-FU
    • arm C: magrolimab + zimberelimab + platinum + 5-FU
On hold NCT04854499

COLIPAN: collection of Liquid Biopsies in Pancancer patients

H&N plaveiselcelCa

1L
  • Liquid Biopsy collection new diagnoses 
  • NO NET-tumours
Open   

MS202359_002 XRay Vision: A randomized, double-blind, placebo-controlled, 2-arm Phase III study to assess efficacy and safety of xevinapant and radiotherapy compared to placebo and radiotherapy

Resected LA SCCHN, high risk, cisplatin-ineligible participants

1L
  • Start of treatment within 4-8 weeks after surgery, no residual disease and no metastasis for cisplatinum ineligible patients
  • HPV negative needs to have pIII or pIV OR HPV positive = smoker > 25PJ and pT3N2 or pT4N2
  • Combination of RT and Xevinapant/placebo 200mg
  • RT will be given for 5 days in 7 for 6,5 weeks in 33 fractions
  • Xevinapant/placebo will be given during 2 weeks of a 3-week-cycle
Open NCT05386550

Hyperlynx: A Single Arm, Open label, Phase 1b Study of Xevinapant in Combination With Weekly Cisplatin and Intensity-modulated Radiotherapy to Assess Safety and Tolerability in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy

Patients with unresected LA SCCHN (stage III, IVA or IVB) 

1L
  • For OPC patients, primary tumors must be HPV-negative as determined by p16 expression using immunohistochemistry
  • Weekly cisplatine for 7 weeks
  • Radiotherapy 5 days per week for 7 weeks
  • Xevinapant 14 days per cycle of 21days for 6 cycles in total
Open NCT06056310

Studies musculoskeletale oncologie (tumoren van de weke delen) 

Title Tumor Type Line of therapy Study information Status Register

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

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
KEYNOTE-676: A Phase 3, Randomized, Comparator-controlled Clinical Trials to study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Bacillus Calmette-Guerin (BCG) in Participants with High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) that is Persistent or Recurrent Following BCG Induction. Non-muscle invasive bladder carcinoma Persistent or recurrent following BCG induction
  • HR NMIBC: recurrent T1, high-grade Ta and/or CIS
  • Persistent: remains present within 3 months (-2 weeks) to 6 months (+4 weeks) after start of BCG induction (note: persistent T1 nog eligible)
  • Recurrent: reappearance of HR NMIBC after achieving a CR or tumor free state within 6 months after start of BCG induction. The recurrence must be within 24 months of last exposure to BCG (+56 days).
  • Prior cystoscopy/TURBT within 12 weeks prior to randomization.
  • For recurrent T1: restaging TURBT between 14-56 days prior to randomization.
 Open  NCT03711032
COLIPAN: collection of Liquid Biopsies in Pancancer patients Prostaat adenoCa 1L
  • Liquid Biopsy collection new diagnoses 
  • No NET-tumours 
Open   

Studies dermatologische oncologie (huidtumoren) 

Title  Tumor Type Line of therapy Study information Status Register
IFX-1-P2.8: Open label, multicenter Phase II study of the C5a-antibody IFX-1 alone or IFX-1 + pembrolizumab in patients with PD-1- or PD-L1-resistant/refractory locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC) Cutaneous squamous cell carcinoma
  • Prior SOC
  • Anti-PD-(L)1 as last line for which progression within 12 weeks from last dose
  • randomization between IFX-1 monotherapy (IV) or IFX-1 with pembrolizumab
  • mandatory baseline biopsy 
Closed NCT04812535


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 56 81 of via research [dot] oncologie [at] uza [dot] be.

Studies thoraxoncologie 

Title Tumor Type Line of therapy Study information Status Register
DOLBY-LC01: Clinical verification study of epigenetic biomarker panels for the diagnosis of lung cancer (stage IV)

NSCLC stage IV and healty subjects

prior to 1L
 
  • Adeno and squamous
  • Healthy subjects:
    • never smoked or stopped >20y and no COPD
    • smoker >20 PY
  • Blood and urine collection
  • Tissue from patients only
  • Sample collection before start 1L
On Hold  
PACIFIC-8: A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab plus Domvanalimab in Participants with Locally Advanced (Stage III), Unresectable NSCLC Whose Disease has not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy

NSCLC stage III

1L maintenance
  • PD-L1 TC ≥ 1% assessed centrally during pre-screening while on cCRT
  • Must have not progressed following cCRT
  • Must have received at least 2 cycles of chemotherapy
  • Total dose of radiation of 60 Gy ± 10% 
Open NCT05211895
JZJX: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib following Definitive Locoregional Treatment in Participants with Stage IB-IIIA RET fusion-Positive NSCLC (LIBRETTO-432) 

NSCLC stage IB-IIIA, RET fusion

1L
  • RET fusion on PCR/NGS
  • Must have received definitive locoregional therapy
  • Max 10 weeks between local therapy and randomization if no chemo
  • Max 26 weeks between local therapy and randomization if adj chemo
  • Crossover possible
Open NCT04819100
KRYSTAL-7: A Phase 2 Trial of MRTX849 Monotherapy and in Combination with Pembrolizumab in Patients with Advanced NSCLC with KRAS G12C Mutation

NSCLC stage IIIB-IV, KRAS G12C

1L
  • KRAS G12C
  • Cohort 1: PD-L1 TPS <1%
  • Cohort 2: PD-L1 TPS ≥1% (CLOSED)
  • Unresectable or metastatic
  • Squamous or nonsquamous
On hold NCT04613596
PACIFIC-4: Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation

NSCLC stage I-II, EGFRm

1L
  • T1a to T3N0M0
  • Medically inoperable or surgery refusal
  • Central or peripheral lesions are eligible
  • (Meta)synchronous NSCLC tumors are allowed (max 2)
  • No durvalumab
  • Ex19del or L858R
Open NCT03833154
HiPeRMESO

Malignant Pleural Mesothelioma

1L, after induction chemotherapy and surgery
 
  • High-Dose RT, Lung-sparing multimodality therapy
  • R0-R1 resection
  • >18 years
  • WHO 0-2
  • DLCO > 40%
Open  
PRIMALung: PRophylactic cerebral Irradiation or active MAgnetic resonance imaging surveillance in small-cell Lung cancer patients

SCLC limited - extensive stage

after 1L
  • Stage I-IV
  • Randomization within 16 weeks after last chemo
  • Immunotherapy continuing adjuvant is allowed
  • No brain metastases and no prior brain RT
Open NCT04790253
COLIPAN: collection of liquid biopsies in pancancer patients 

NSCLC adenoCa,

NSCLC plaveiselcelCa

1L
  • Liquid Biopsy collection new diagnoses 
  • No NET tumors 
Open   
LUNG Platform: A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants with Previously Untreated, Locally Advanced/Metastatic, PD-L1-Selected NSCLC

NSCLC stage III-IV, PD-L1 high

1L
  • PD-L1-high (TC/TPS >=50%) by 22C3 or SP263
  • smoked >100 cigarettes in a lifetime (former/current)
  • squamous and non-squamous

Open cohorts:

  • Pembrolizumab monotherapy
  • Dostarlimab monotherapy
  • Substudy 1B: Dostarlimab + Belrestotug 400mg
  • Substudy 2A: Dostarlimab + Belrestotug 400 mg + GSK6097608 1400 mg
 Open NCT05565378
LAGOON: A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination with Irinotecan versus Investigator’s Choice (Topotecan or Irinotecan) in Relapsed SCLC Patients

SCLC limited - extensive stage

2L
  • prior platinum chemotherapy +/- anti-PD-(L)1 (>=70% of patients included must have been pretreated with anti-PD(L)1
  • last dose of platinum to PD >= 30 days
  • if CNS metastases: pretreated, stable and asymptomatic
  • limited-stage disease who are candidates for local/regional therapy, must have been offered that option and completed/refused it
Open NCT05153239
SAFFRON: A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Vs Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic NSCLC Who Have Progressed on Treatment With Osimertinib

NSCLC stage III-IV, EGFRm

2-3L
  • At least 1 sensitising EGFR mutation: exon19 deletion, L858R mutation and/or T790M
  • Osimertinib as most recent, in 1L or 2L
  • Chemotherapy and immunotherapy naïve in metastatic setting
  • No other prior third-generation EGFR-TKI
  • MET overexpression and/or amplification assessed in central lab
Open NCT05261399
LONG 20-06: development of a blood test for prediction of response and toxicity to immunotherapy in lung cancer

NSCLC

1L
  • Blood collection in inoperable/relapsed NSCLC starting ICI treatment 
  • 1st sample collection before start therapy
Open  /
TeliMET NSCLC-01: A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects with Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous NSCLC

NSCLC stage III-IV

>1L
  • 1 prior platinum chemotherapy + 1 checkpoint inhibitor (+ targeted therapy if indicated)
  • c-Met overexpression assessed centrally
  • No prior cMET therapy
  • Treated brain mets are eligible
Open NCT04928846
DDRiver NSCLC 322: An Open label, Multicenter, Phase 1b/2a Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of the ATR inhibitor M1774 in Combination with Cemiplimab in Participants with Non-Squamous NSCLC that has Progressed on Prior Anti-PD-(L)1 and Platinum-based Therapies

NSCLC stage III-IV

>1L
  • non-squamous
  • prior platinum chemo + anti-PD-(L)1 (+ targeted therapy if indicated, but no EGFR or ALK)
  • fresh biopsy
Open NCT05882734

 

Pijncentrum

Heb je vragen over de studies van het pijncentrum? Neem gerust contact met ons op via +32 3 436 81 65 (Eva Wauters) of via studies [dot] pijncentrum [at] uza [dot] be.

Studies pijncentrum

Title Tumor Type Line of therapy Study information Status Register

ATX01-22-01-CIPN: A multicenter, 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)

Adult cancer survivor patients with CIPN / polyneuropathy (hands and/or feet) (treated by taxanes or platins or any other neurotoxic chemotherapy)  Patients who stopped their chemotherapy treatment for >= 24 weeks at the time of screening visit
  • Randomly assigned in a 1:1:1 ratio to ATX01 10%, ATX01 15% and placebo groups
  • Study duration: 12 weeks
  • Patient with CIPN pain for >= 24 weeks
  • 18 years and older
  • With an estimated life expectancy of >= 6 months at study entry
Open  
Laatst aangepast: 16 april 2024
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