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Studies oncologie

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. 

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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 
TVEC: phase 1b/2 of Talimomgene Laherparepvec injected into liver tumors alone and in combination with Pembrolizumab
  • TNBC
  • Basal cell carcinoma
≥1L

 TVEC intrahepatic Q3W - Pembrolizumab Q3W IV 

Open NCT02509507
Precision 2 afatinib: phase 2 with afatinib in tumors with EGFR, HER2 or HER3 mutation followed by addition of paclitaxel to afatinib at disease progression Solid >1L
  • Accepted mutations:
    • EGFR
    • HER2 --> Closed
    • HER3
  • Exclusion: NSCLC with EGFR mutation
  • Afatinib 40mg/day with increase to 50 mg.
Open  NCT03810872

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

  • NSCLC PD-L1 +, TPS >= 50
  • 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

  • NSCLC: no EGFR or ALK genomic aberrations, no prior systemic therapy for advanced disease

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

  • Esophageal
  • Esophageal: 2L
  • Esophageal: prior fluoropyrimidine and platinum. Study treatment: gevokizumab + paclitaxel + ramucirumab.
Open  NCT03798626 

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

NSCLC Multiple
  • KRAS p.G12C mutation
  • NSCLC: progression after anti-PD1/anti-PDL1 AND/OR platinum-based combination therapy AND targeted therapy. Not more than 3 prior lines of therapy.

Open

NCT03600883

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:
      •      Low-grade gliomas
      •      SCCHN
      •      Endometrial
      •      Cervix
      •      Ovarian
      •      squamous NSCLC
      •      Esophageal
      •      Gastric
      •      Breast: only HR+
      •      Pancreatic
      •      Colorectal
  • 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
  • Cohort 2c: 2L
  • Cohort 2b: prior neoadjuvant SOC
  • Cohort 2c: ongoing PR or SD after completion of 1st line SOC therapy (min. 6 months)
  • Cohort 2b: no PD on prior neoadjuvant SOC, m+ limited to liver, eligible for en block surgery with curative intent
  • 1 liver lesion amenable to repeated biopsy
  • ATP128: chimeric recombinant protein vaccine
  • BI754091: anti-PD1
Slots

 

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

  • Other solid tumors (except NSCLC): RET fusion
  • Other solid tumors (except NSCLC): previously treated with SOC therapy
  • Oral medication 
Open 

NCT03037385

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
Slots

NCT04235101

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

  • MSI-H/d MMR tumors
  • 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

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

  • Adenocarcinoma of the pancreas (≤ 60 years old at the time of diagnosis)
  • Cancer of unknown primary (CUP)
  • Breast (ER positive, HER2 negative, PIK3CA wild type or unknown)
  • Ovarian/Endometrium
  • Bladder/Renal
  • Cholangiocarcinoma (IDH/FGFR2 wild type or unknown)/Gall bladder
  • Stomach (HER2 negative)/Esophageal
  • Colon
  • Prostate (CRPC)
  • Any other solid tumor except non-castration resistant prostate cancer and central nervous system tumors
All 
  • Sponsor: Merus 
  • Whole genome sequencing of RNA/DNA (200 genes) 
  • Locally advanced/metastatic
  • Has been or is currently being treated with SOC
  • No known mutations: ALK, BRAF, EGFR, KRAS, MET, NRAS, RET, ROS1 and absence of known mutations on actionable genes 
  • PS 0-2
  • In case of NRG1 fusion, possibility to enter Early Access Program examining the safety and efficacy of Zenocutuzumab (www.nrg1.com)
Open   

BOT112-02: Phase IIa open-label clinical study of intratumoural administration of BO-112 in combination with pembrolizumab in subjects with liver metastasis from colorectal cancer or gastric/gastro-oesophageal junction cancer.

  • Arm A: CRC
  • Arm B: GC/GEJ
  • ARM A: >= 3L
  • Arm B: >=2L 
  • Pembrolizumab IV Q3W + BO-112 intrahepatic Q3W
  • Primarily liver disease
  • At least 1 liver m+ of >=20mm suitable for percutaneaous, intra-tumoral injection
  • Mandatory on-study biopsy 
  • anti-PD(L)-1 naive 
Hold  NCT04508140

Precision-2 olaparib: Efficacy of Olaparib in advanced cancers occurring in patients with germline mutations or somatic tumor mutations in homologous recombination genes.

  • HRD mutated tumor 
  • except ovarian and BRCA1/2 mutated breast
prior SOC
  • Olaparib 300mg BID
  • Accepted mutations:
    • BRCA1
    • BRCA2
    • ATM --> Closed
    • BARD1
    • BRIP1
    • CHEK1
    • CHEK2 --> Hold
    • MRE11A
    • NBN
    • PALB2
    • RAD50/51B/51C/51D/54L
    • FAM175A
    • CDK12
    • FANCL
    • p53 (germline)
    • PPP2R2A
Open  NCT03967938

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 A1: Three patients with advanced solid cancer will be subjected to repetitive hyperthermia starting with 2 hours (day 1), 4 hours (day 8) and 6 hours (day 15)
  • 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 B1: Three pancreatic cancer patients will be subjected to repetitive hyperthermia starting with 2 hours (day 1), 4 hours (day 8) and 6 hours (day 15) using the device and in combination with the standard of care chemotherapy (FOLFIRINOX, FOLFOX, gemcitabine/nab-paclitaxel or gemcitabine alone).
  • Cohort B2: The highest whole-body hyperthermia duration with acceptable side effects from cohort B1 will be applied in combination with chemotherapy (FOLFIRINOX, FOLFOX, gemcitabine/nabpaclitaxel or gemcitabine alone) to three additional pancreatic cancer patients, once a week and for 15 days in total
Open NCT04467593

INCB99280-112: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors

  • MSI-high or MMR-deficient tumors (all types except brain)
  • Cutaneaous squamous cell carcinoma
  • HCC
  • DL-1 positive esophageal squamous cell carcinoma
  • Merkel cell carcinoma
  • SCLC
  • PDL-1 positive mesothelioma
  • Any PDL-1 amplified tumor (9p24.1)
  • Urothelial carcinoma with CPS >= 10%
  • 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 regimens, but maximum 1 line of immune therapy
  • Prior anti-PD-L1 is exclusion
  • Oral anti-PD-L1
  • Mandatory screening + on treatment biopsy
Slots NCT04242199

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 -> hold 
  • 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

BP42169: An Open-Label Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7293583, A TYRP1-Targeting CD3 T-Cell Engager, in Participants With Metastatic Melanoma

TYRP-positive melanoma

  • Progressed after SOC or intolerant/ineligible for SOC
  • No limit to number of prior treatment regimens
  • TYRP-prescreening on archival/fresh tissue mandatory
  • RO7293583 IV Q3W with hospitalization after 1st administration
  • Mandatory screening + on treatment biopsy
Open

NCT04551352

ARRAY 818-103: An Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered With Encorafenib and Binimetinib in Patients With BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors

BRAF V600E/V600K mutated solid tumors

  • Progressed after SOC or intolerant/ineligible for SOC
  • No limit to number of prior treatment regimens
  • Prior BRAF/MEK inhibitor is permitted, except as last line
  • Arm 1: CYP probe cocktail (oral) + encorafenib and binimetinib
  • Arm 3: modafinil (oral) + encorafenib and binimetinib --> Hold
  • After drug-drug interaction period (first 28 days), patient proceeds with encorafenib and binimetinib
Open 

NCT03864042

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

  • NSCLC with ROS1 rearrangements
  • Solid tumors with NTRK rearrangements
  • NSCLC: maximum 2 prior TKI’s, maximum 1 prior line of chemotherapy/immune therapy
  • 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

JZLA/EMBER: A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With ER+ Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers

  • Part A: ER+/HER2- mBC
  • Part B: ER+/HER2- mBC
  • Part C: ER+/HER2+ mBC
  • Part D: ER+ endometroid endometrial cancer
  • Part A: no prior CDK4/6i, max. 1 prior line for advanced disease
  • Part B: prior CDK4/5i, max. 2 prior lines for advanced disease with only 1 prior HT
  • Part C: min. 2 prior HER2 directed regimens for advanced disease, prior trastuzumab & pertuzumab & TDM-1, no prior CDK4/6i, no prior fulvestrant
  • Part D: progression on platinum-based SOC, no prior AI, no prior fulvestrant
  • LY3484356 (oral) monotherapy or in combination with other drugs
  • Part A: LY3484356 + abemaciclib +/- AI
  • Part B: LY3484356 monotherapy
  • Part C: LY3484356 + trastuzumab +/- abemaciclib
  • Part D: LY3484356 +/- abemaciclib
Slots

NCT04188548

FIDES-03: Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma

  • Gastric adenocarcinoma
  • HER2 negative
  • FGFR2 fusion/amplification or FGFR1-3 mutation as per central testing (liquid biopsy) 
  • No prior treatment with FGFR inhibitors 
  • Substudy 1: 2/3L
  • Substudy 2: 2L
  • Mandatory prescreening on liquid biopsy 
  • Substudy 1: derazantinib (oral)
  • Substudy 2: derazantinib (oral) + paclitaxel (IV QW) + ramucirumab (IV Q2W) 
  • Intensive PK sampling 
Open 

NCT04604132

A study to examine the value of broad agnostic NGS panel testing versus reimbursed organ-directed NGS: a Belgian Precision study of the BSMO in collaboration with the Cancer Centre – GeNeo

 
  • All (early lines are preferred)
  • Sponsor: BSMO
  • Patients with advanced/metastatic solid tumors that are candidates for systemic therapy
  • 3 clinical scenarios:

1. Patients eligible for locas NGS (reimbursed or local pracitce)

2. Patients not eligible for reimbursed or local NGS testing

3. Patients with no sufficient archival tissue -> liquid biopsy (limited number) 

  • Patients should also enter the Precision1 trial (registration on clinical and NGS data) 
Open   

BAYER21136: A Multi-indication, Open-label Phase 2 Study of Regorafenib and Nivolumab in Combination in Patients with Recurrent or Metastatic Solid Tumors

  • HNSCC IO treated
  • ESCC
  • PDAC (Closed)
  • BTC
  • GMB grade IV / AA grade II  (Closed)
  • HNSCC IO treated: 2-4L with 1 prior anti-PD(L)1 for which progression
  • ESCC: 2L after platinum and/or fluoropyrimidine, no prior taxane or immune therapy
  • PDAC: 2-3L after gemcitabine or fluoropyrimidine, no prior immune therapy --> Closed
  • BTC: 2-3L after gemcitabine or fluoropyrimidine or platinum or combination, no prior immune therapy
  • GMB grade IV / AA grade II: 1st progression after surgery, RT and temozolomide, no prior immune therapy  --> Closed
  • Regorafenib PO + nivolumab IV Q4W 
Slots 

NCT03406871

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 D: solid tumors with TMB >= 16
  • Cohort E: solid tumors with AKT1/2/3 point mutation
  • Cohort F: solid tumors with HER2 point mutation, except primary CNS (Hold)
  • Cohort H: solid tumors with >= 2 PIK3CA point mutations
  • 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 D: prior SOC/none available, prior CF137 agonist or checkpoint inhibitor are exclusions
  • Cohort E: prior SOC/none available, prior AKT inhibitor is exclusion
  • Cohort F: prior SOC/none available, prior doxorubicin > 500mg/m2 and prior trastuzumab emtansine are exclusions --> Hold
  • Cohort H: prior SOC/none available, prior PIK3 inhibitor is exclusion
  • Cohort A: entrectinib oral
  • Cohort B: entrectinib oral
  • Cohort C: alectinib oral
  • Cohort D: atzeolizumab IV
  • Cohort E: ipatasertib oral, specific mutations
  • Cohort F: kadcyla IV, specific, specific mutations --> Hold
  • Cohort H: inavolisib oral, specific mutations
Open 

NCT04589845

Destiny-PanTumor01: A Phase 2 Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for the Treatment of Unresectable and/or Metastatic Solid Tumors Harboring HER2 Activating Mutations Regardless of Tumor Histology

  • All solid tumors with specific HER2 activating mutations
  • Prior SOC or no SOC available
  • Prior HER2 targeting therapy is allowed
  • Trastuzumab Deruxtecan (T-DXd) IV Q3W
Open 

NCT04639219

BI1472-0001: A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation

  • All solid tumors with KRAS G12C mutation
  • Prior SOC or no SOC available
  • Prior RAS, MAPK or SOS1 targeted therapy is not allowed
  • Oral study medication
  • Intensive PK sampling with overnight hospital stays
Slots

NCT04973163

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

  • NSCLC with EGFR mutation or activating cMET mutation/amplification
  • GC/GEJ adenocarcinoma with EGFR amplification or cMET amplification
  • HNSCC
  • ESCC
  • Prior SOC or intolerance
  • MCLA-129 IV Q2W: biospecific monovalent EGFR x cMET antibody
  • Mandatory on-treatment biopsy
  • Intensive PK sampling with overnight hospital stay
Slots 

NCT04868877

OPTIMIZE-1: A 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
  • 1st line (previously untreated)
  • Mitazalimab (CD40 agonist) IV Q2W + mFOLFIRINOX Q2W
  • Mandatory pre- and on- study biopsies
Sltos

NCT04888312

Destiny-Lung03: Phase Ib Study of the Safety of T-DXd and Durvalumab With Chemotherapy in Advanced or Metastatic HER2+ Non-squamous NSCLC

  • Non-squamous mNSCLC
  • Her2+ (IHC 2+/3+)
  • 2-3L
  • After targeted therapy (if applicable)
  • Her2 activating mutations NOT allowed
  • T-DXd Q3W + durvalumab Q3W + cisplatinum or carboplatinum
  • Intensive PK sampling during first cycle
Slots 

NCT04686305

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

A study to examine the clinical value of comprehensive genomic profiling performed by Belgian NGS laboratories: a Belgian Precision study of the BSMO in collaboration with the Cancer Centre – BALLETT

All solid tumors
  • All (early lines are preferred)
  • Sponsor: BSMO
  • Patients with advanced/metastatic solid tumors that are candidates for systemic therapy
  • Life expectancy < 12 weeks
  • ECOG ≤ 2
  • Tumor tissue < 2 years old
  • Patients should also enter the Precision-1 trial (Health Data database - Sciensano)
  • National ‘Molecular Tumor Board’ provides therapy recommendation based on CGP results
Open 

NCT05058937

Studies borstkanker 

Title Tumortype Line of therapy Study information Status Register
DESTINY-06: A Phase 3, Randomized, Open-Label Study of Trastuzumab Deruxtecan (T-DXd) vs. Investigatior's Choice Chemotherapy in HER2-low, Hormone Receptor Positive Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy in the Metastatic Setting.

HR + and HER2 low or - :

- IHC 2+/ISH-

- IHC 1+/ISH- or untested

- IHC 0/ISH- or untested

1 L chemo
  • HER2 central confirmation necessary
  • progressed on min. 2 prior lines ET for mBC
  • no prior chemotherapy for aBC/mBC
  • no history of (non-infectious) ILD/pneumonitis
Open NCT04494425
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
Hold NCT02102165
SERENA-4: A Randomised, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) plus Palbociclib vs Anastrozole plus Palbociclib for the Treatment of Patients with ER-Positive, HER2-Negative Advanced Breast Cancer  who Have Not Received Any Systemic Treatment for Advanced Disease HER2-/ER+ 1L
  • AZD9833/Placebo + Placebo/Anastrazole + Palbociclib
  • De novo m+ allowed
  • If adj. ET treatment: min 24 months AI or Tamoxifen
  • If adj. AI +/- CDK4/6 inhibitor: PD after min. 12 months completion of adj. therapy
Open  
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
 Closed NCT04305496
WO41554/INAVO120: Phase III, double-blind, placebo-controlled study evaluating the efficacy and safety of GDC-0077/Placebo plus Palbociclib and Fulvestrant in patients with PIK3CA-mutant, Hormone Receptor-Positive, Her2-Negative locally advanced or metastatic breast cancer. HER2-/HR+ 1L
  • PIK3CA mutant
  • PD on or within 12 months of completing adjuvant treatment
  • Measurable disease per RECIST 1.1
  • GDC-0077/Placebo + Fulvestrant + Palbociclib
Open NCT04191499
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

MK-3475-756/KEYNOTE-756: A randomized, double-blind, phase 3 study of Pembrolizumab vs Placebo in combination with neoadjuvant chemotherapy and adjuvant endocrine therapy for the treatment of high-risk early-stage ER+/HER2– breast cancer.

ER+/HER2- Neo-adjuvant, adjuvant
  • T1c (>= 2cm) or T2 + cN1-N2, or T3-T4 + cN0-N2
  • Centrally confirmed ER+/HER2–, grade 3, ductal histology
  • Neoadjuvant: 
    • Cycle 1-4: Pembrolizumab/Placebo Q3W + paclitaxel QW; 
    • Cycle 5-8: Pembrolizumab/Placebo Q3W + AC Q2W.
  • Adjuvant: Pembrolizumab/Placebo Q3W + HT
Open  NCT03725059

SGNTUC-016: Randomized, double-blind, phase 3 study of tucatinib/placebo in combination with T-DM1 for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer who were previously treated with a taxane and trastuzumab in any setting, separately or in combination (HER2CLIMB-02).

HER2+ 1-2L
  • Progression after last systemic therapy or be intolerant of last systemic therapy;
  • HER2 central confirmation prior to randomization;
  • Prior treatment with a taxane and trastuzumab in any setting, separately or in combination. Prior pertuzumab is allowed, but not required;
  • Measureable or non-measurable disease per RECIST v1.1;
  • Patients with or without brain metastases;
  • No prior treatment with T-DM1, tucatinib, neratinib, afatinib, DS-8201a, or any other investigational anti-HER2, anti-EGFR, or HER2 TKI agent.
Open  NCT03975647

CA209-7FL: A randomized, multicenter, double-blind, placebo-controlled phase 3 study of nivolumab/placebo in combination with neoadjuvant chemotherapy and adjuvant ET in patients with high-risk, ER+, HER2- primary breast cancer (Checkmate-7FL).

ER+, HER2- Neo-adjuvant, adjuvant
  • T1c-T2 (≥ 2 cm) and N1-N2; or T3-T4 and N0-N2. Multifocal or inflammatory BC is allowed;
  • Centrally assessed: ER+ with or without PR expression;
  • Grade 2 with ER expression level 1-10% or Grade 3;
  • Neoadjuvant: 
    • cycle 1-4: nivolumab 360mg /placebo Q3W + paclitaxel QW
    • cycle 5-8: nivolumab 360mg/placebo Q3W + AC Q3W, or nivolumab/placebo 240mg Q2W + AC Q2W.
  • Adjuvant: 
    • nivolumab/placebo 480mg Q4W + ET.
Open  NCT04109066

DESTINY-05: A phase 3, multicenter, randomized, open-label, active-controlled study of trastuzumab deruxtecan (T-DXd) vs T-DM1 in subjects with high-risk HER2-positive primary breast cancer who have residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy.

HER2+ Adjuvant
  • HER2+ centrally confirmed prior to randomization.
  • Operable at presentation: cT1-3,N0-1,M0, with axillary node positive disease (ypN1-3) following neoadjuvant therapy.
  • Inoperable at presentation: cT4,N0-3,M0 or T1-3,N2-3,M0. 
  • At least 6 cycles of neoadjuvant chemotherapy (min 16 weeks in total), including min. 9 weeks of trastuzumab + min. 9 weeks of taxane based chemotherapy.
  • No prior treatment with T-DXd, T-DM1 or other anti-HER2 antibody-drug conjugate.
Open  NCT04622319

JPCW: A randomized, double blind, placebo-controlled phase 3 study of Abemaciclib plus standard adjuvant endocrine therapy in participants with high-risk, node-positive, HR+, HER2+ early breast cancer who have completed adjuvant Her2 targeted therapy

HER2+ Adjuvant
  • After SOC adjuvant HER2 therapy
  • Node positive on surgical specimen
  • Randomized within 12 weeks of completion of adjuvant HER2 therapy
  • ET + Abemaciclib/Placebo
Open NCT04752332

Studies gynaecologische oncologie 

Title Tumortype Line of therapy Study information Status Register

HPV001/APOLLO: A Phase 1b/2, Randomised, Placebo-controlled, Dose-ranging Study to Evaluate Safety, Tolerability and Immunogenicity of a Chimpanzee Adenovirus (ChAdOx1)-vectored Multigenotype High Risk Human Papillomavirus (hrHPV) Vaccine and Modified Vaccinia Ankara (MVA)-vectored Multigenotype hrHPV Vaccine in Women with Low-grade HPV-related Cervical Lesions

  • Persistent high-risk HPV infection
  • With cevical LSIL: CIN1 or HPV-related change only
  • >= 25y and <= 55y old
Not applicable 
  • Randomized trial: vaccination vs placebo
  • injection on D0 and D25 with in-clinic visits in between and afterwards 
Slots  NCT04607850

MK-3475-A18/ENGOT-cx11: Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer 

Cervix: locally advanced  1st line
  • Locally advanced is defined as: FIGO IB2-IIB with positive pelvic or para-aortic lymph nodes or FIGO III-IVa
  • 1:1 randomisation: chemoradiation (cisplatin QW) + pembrolizumab Q3W or placebo Q3W
  • Carboplatin is not allowed in the study
Open  NCT04221945

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 --> Closed
Open  NCT02162563

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 (closed) or FGFR2 gene mutations or amplifications who received at least one prior regimen of systemic therapy
Open NCT03230318

LEAD-IN FOLICOLOR Trial: Detection of progressive disease in metastatic colorectal cancer patients by NPY methylation in liquid biopsies.

Unresectable metastatic colorectal cancer 

1
  • Wild-type RAS tymor status
  • Wild-type BRAF tumor status
  • Unresectable mCRC
  • First-line treatment: FOLFOX/FOLFIRI + panitumumab
  • ECOG performance status of 0 or 1
  • Man or Woman >= 18 years of age
Open  

PROMETCO

Metastatic colorectal cancer

3
  • Non-interventional observational prospective study to collect data on patient with mCRC after 2 disease progressions since first diagnosis.

Open  NCT03935763

YO42137

 Unresectable locally advanced esophageal squamous cell carcinoma   1
  • Arm A: Tiragolumab + atezolizumab
  • Arm B: Tiragolumab + placebo 
  • Arm C: placebo + placebo 
  • Randomized (1:1:1), double-blind, phase III study 
  • Stage II-IVA esophageal squamous cell (8th edition) 
  • Received at least 2 cycles platinum-based chemo and radiation consistent with definitive treatment without evidence of disease progression 
  • Randomization must occur with 1-63 days after last dose definitive concurrent chemo radiotherapy  
 Open  NCT04543617

QBGJ398-301/PROOF trial

 Advanced/metastatic or inoperable cholangioCA   1
  • Arm 1: Infigratinib (oral) 
  • Arm 2: Gemcitabine + Cisplatin 
  • Randomized (1:1), open label, phase III study 
  • FGFR2 gene fusion/translocation  
 Open  NCT03773302

MK7339-003

 

Unresectable or metastatic colorectal cancer without progression on 1ste line FOLFOX

 

1

  • Arm 1: Olaparib (oral) + Bevacizumab
  • Arm 2: Olaparib mono 
  • Arm 3: 5-FU + bevacizumab 
  • Randomized (1:1:1), open-label, phase III study 
  • Has not progressed after completing at least 6 prior induction cycles of FOLFOX + bevacizumab and can no longer tolerate oxaliplatin  
 Open  NCT04456699

FRESCO-2

Refractory metastatic colon cancer

>3

  • Arm 1: Fruquintinib (oral) + BSC 
  • Arm 2: placebo + BSC 
  • Randomized (2:1), double-blind study, phase III study 
  • Must have progressed on or been intolerant to treatment with TAS-102 and / or regorafenib, 5-FU, oxaliplatin, irinotecan, anti-VEGF, if RAS wild-type an anti-EGFR.
Open NCT04322539

MATTERHORN (D910GC00001)

Resectable gastric and gastroesophageal junction cancer Neo adjuvant + adjuvant
  • neo-adjuvant Durvalumab/placebo (D1) + FLOT (D1+D15) Q4W x 2 cycles
  • surgery 
  • adjuvant Durvalumab/placebo(D1) + FLOT (D1+D15) Q4W x 2 cycles
  • Double-blind phase 3 trial
  • Stage II or higher (per AJCC 8th edition)
  • Tumor tissue < 3 months prior enrollment must be available for central PD-L1 status
Open  NCT04592913

MS202202-0002

Advanced (locally or metastatic) left sided, RAS/BRAF wild-type CRC 2L
  • Tepotinib + cetuximab 
  • Phase 2 trial
  • Resistance to anti-EGFR antibody targeting therapy due to MET amplification
  • Anti-EGFR as most recent line before study treatment with PR or CR for at least 4 months or SD for at least 6 months prior progression
  • Less than 2 months between last administration anti-EGFR and first dose in this study
Open NCT04515394

BP42772 (TALIOS): A Study of RO7121661 and RO7247669 Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus

Squamous cell carcinoma of the esophagus (ESCC) 2L
  • If no prior radical resection: 1st L must have been fluoropyrimidine/taxane + platinum
  • If prior curative intent (chemoradiation or R0 resection + chemotherapy +/- RT) and recurrency > 24w: additional fluoropyrimidine/taxane + platinum needed
  • Randomized study: nivolumab IV Q2W or RO7121661 IV Q2W or RO7247669 IV Q2W
Open NCT04785820

DS8201-A-U207 (DESTINY COLON)

Unresctable or metastatic colorectal cancer with HER2 overexpressing After SOC 
  • Trastuzumab deruxtecan (IV) at a dose of 5.4 mg/kg or 6.4 mg/kg Q3W 
  • Prescreening: HER2 status (IHC 3+ or IHC 2+/ISH+)
Open  NCT04744831

ACT16444

Gastric or GEJ adenocarcinoma with CEACAM5 -positive tumors 2L
  • Tusamitamab ravtansine with ramicirumab
  • Expression of CEACAM5 – centrally assessed
  • Measurable disease
  • Progression during or after 1st line platinum and/or 5FU containing regimen and HER2 therapy is applicable
Open  

CNIS793B12301

Metastatic pancreatic cancer 1L
  • NIS793 versus placebo with gemcitabine and nab-paclitaxel
expected NCT04935359

FOENIX-CCA3 

(TAS-120-301)

 
Advanced cholangioCA with FGFR2 gene rearrangements 1L
  • Futibatinib versus gemcitabine- cisplatin
expected NCT04093362

Studies hoofd- en halsoncologie

Title Tumortype Line of therapy Study information Status Register
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 --> Closed
  • 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 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
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
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

SCCHN 

  • oral cavity
  • pharynx
  • larynx
  • sinonasal
  • nasopharyngeal
  • unknown primary
>1L
  • 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

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
Open  NCT04211337 

INTERLINK-1: A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Patients With Recurrent or Metastatic HNSCC Previously Treated With an Immune Checkpoint Inhibitor

SCCHN: 

  • oral cavity 
  • oropharynx
  • hypopharynx
  • larynx
2-3L
  • prior PD-(L)1
  • prior platinum failed for R/M or locally advanced
  • provide recent tumor tissue
Open  NCT04590963 

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) --> Hold
  • Irinotecan and Temozolomide (IT) --> Closed
  • Gemcitabine and Docetaxel (GD) --> Closed
  • High dose Ifosfamide (IFOS)
  • >=4 years and <50 years
Hold   

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
CA045-009: A Phase 3, Randomized Study of Neoadjuvant and Adjuvant Nivolumab Plus NKTR-214 Vs Nivolumab Alone Vs Standard of Care in Participants with MIBC Who Are Cisplatin Ineligible. High-risk muscle invasive bladder carcinoma Neo-adjuvant + Adjuvant
  • cT2-T4aN0M0
  • cisplatin ineligible
  • TURBT within 12 weeks of randomization
  • PD-L1 IHC done centrally
  • no urothelial carcinoma of upper urinary tracts
  • Arm A: Nivo + NTRK214 - RC - Nivo + NTRK214
  • Arm B: Nivo - RC - Nivo
  • Arm C: RC only
Open  NCT04209114 
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

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
INITIUM: A Randomized Phase II, Open-label, Active-controlled, Multicenter Study Investigating the Efficacy and Safety of UV1 Vaccination in Combination with Nivolumab and Ipilimumab as First-line Treatment of Patients with Unresectable or Metastatic Melanoma Melanoma 1L
  • Unresectable stage IIIB-D or IV
  • No uveal or ocular melanoma 
Open NCT04382664 
IMCODE001: A Phase 2, Open-Label, Multicenter, Randomized Study of The Efficacy and Safety of RO7198457 in Combination With Pembrolizumab vs Pembrolizumab in Patients with Previously Untreated Advanced Melanoma  Melanoma 1L
  • Unresectable stage IIIC-D or IV
  • No mucosal, acral, uveal or ocular melanoma
  • Cross-over possible
Open NCT03815058 
POLARIS: A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain Metastasis Melanoma 1-2L
  • at least 1 parenchymal brain lesion ≥ 0.5 cm and ≤ 4 cm
  • brain metastasis must be asymptomatic
  • prior local therapy for brain metastases is allowed
  • may have received prior immunotherapy
  • no uveal or mucosal melanoma
Closed NCT03911869 
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 
Open  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 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
NIVOTHYM: Single-arm, Multicentre, Phase II Study of Immunotherapy in Patients With Type B3 Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy thymoma/thymus carcinoma >1L
  • at least one previous line of platinum-based chemotherapy.
  • nivolumab + ipilimumab
  • re-challenge possible after PD
Open   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
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
ANAM-17-21: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ANAMORELIN HCL FOR THE TREATMENT OF MALIGNANCY ASSOCIATED WEIGHT LOSS AND ANOREXIA IN ADULT PATIENTS WITH ADVANCED NSCLC

 

NSCLC stage III-IV

All
  • BMI < 20
  • weight loss of >2% within 6 prior months
  • problems with appetite/eating associated with cancer
  • no reversible cause of reduced food intake
  • on or off anti-cancer treatment
Open

NCT03743064 

LUMINOSITY: Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ NSCLC

NSCLC

2-3L
  • c-Met+ assessed by IHC (central)
  • prior chemotherapy and prior immune checkpoint (N/A if mutant) and prior TKI (sequential lines count as 1)
  • pre-screening can be done during prior line
  • Non-Sq EGFR WT c-MET high Stage 2
  • Non-Sq EGFR WT c-MET intermediate Stage 2
  • Non-Sq EGFR Mut c-MET high Stage 1 -> Closed 
  • Non-Sq EGFR Mut c-MET intermediate Stage 1 -> Closed
  • Squamous -> Closed
Open

NCT03539536 

ALKALINE: Activity of Lorlatinib based on ALK resistance mutations on blood in ALK positive NSCLC patients previously treated with 2nd generation ALK inhibitor

NSCLC

>1L
  • stage IIIB - IV
  • ALK rearrangement, by FISH or IHC
  • treated with at least 1 2nd-generation ALK inhibitor
  • samples collected for cohort allocation during screening
  • prospective sub-study: 3-monthly LBx during the ongoing response to 2nd-generation ALK inhibitor
open 

NCT04127110 

PYRAMID-1: A Phase 3, Randomized, Open-label, Multicenter Study of the Efficacy and Safety of Pyrotinib vs Docetaxel in Patients with Advanced NSCLC Harboring a HER2 Exon 20 Mutation who Progressed on or after Treatment with Platinum Based Chemotherapy

NSCLC

2-3L
  • stage IIIB-IV
  • activating mutation in HER2 exon 20
  • prior platinum +/- immune checkpoint inhibitors
Open 

NCT04447118 

ZEAL-1L: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease has Remained Stable or Responded to First-Line Platinum-Based Chemotherapy with Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer

NSCLC

1L maintenance
  • stage IIIB/IIIC or IV
  • without known targetable driver alteration
  • completed at least 4-6 cycles of SOC 1L platinum-based induction chemotherapy + pembrolizumab
  • SD, PR, or CR after 1L
  • tissue to be submitted for central PD-L1 testing
Open 

NCT04475939 

Laatst aangepast: 22 oktober 2021
Auteur(s):