Clinical trials: sponsored by The Netherlands Cancer Institute
NSCLC
The Food-effect on Alectinib Pharmacokinetics
The goal of this food-effect study on Alectinib pharmacokinetics is to learn about the food effect of alectinib. The main question aims to answer is: To determine the food-effect of a standardized Dutch breakfast on the…
- Trial name
- NCT05710133
- Testing
- food, fast
- Where
- Netherlands
- Volunteers
- 10 people
- Sponsor
- The Netherlands Cancer Institute
Cutaneous Squamous Cell Carcinoma (CSCC), Cutaneous Squamous Cell Cancer
Towards Cure Via Only Ultra-short ICB in CSCC
The goal of this clinical trial is to determine whether cutaneous squamous cell carcinoma patients can be cured using only immunotherapy, without surgery or radiotherapy.
- Conditions
- Cutaneous Squamous Cell Carcinoma (CSCC), Cutaneous Squamous Cell Cancer, Cutaneous Squamous Cell Carcinoma of the Head and Neck, Cutaneous Squamous Cell Carcinoma
- Trial name
- MATISSE 2 (NCT06823479)
- Testing
- Nivolumab, Ipilumimab
- Where
- 5 sites in Netherlands
- Volunteers
- 41 people
- Sponsor
- The Netherlands Cancer Institute
Breast Cancer Stage I, Triple Negative Breast Cancer (TNBC)
OPTImaL:Optimisation of Treatment for Patients With Low Stage Triple-negative Breast Cancer With High Stromal Tumor-infiltrating Lymphocytes
The aim of this study is to investigate whether subjects with breast cancer that have certain favorable features, after performing the surgery and radiation, the chemotherapy can be safely omitted in the treatment.
- Trial name
- OPTImaL (NCT06476119)
- Testing
- Adjuvant chemotherapy, No adjuvant chemotherapy
- Where
- 28 sites in Netherlands
- Volunteers
- 490 people
- Sponsor
- The Netherlands Cancer Institute
Breast Cancer
The SONImage Study
SONImage is a multicenter prospective imaging side study, in which a baseline FES-PET is added to conventional work up, in 100 patients with ER+ MBC who will receive endocrine treatment ± CDK 4/6 inhibition within the SONIA study…
- Trial name
- SONImage (NCT04125277)
- Testing
- FES-PET scan, and possibly one additional visit for an FDG-PET
- Where
- 2 sites in Netherlands
- Volunteers
- 100 people
- Sponsor
- The Netherlands Cancer Institute
Breast Cancer
DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
This study evaluates whether radiotherapy can safely be omitted in breast cancer patients with T1-2N0 tumors who achieve a pathologic complete response after neoadjuvant systemic therapy and breast-conserving surgery
- Trial name
- NCT05416164
- Testing
- Omission of radiotherapy
- Where
- Netherlands
- Volunteers
- 595 people
- Sponsor
- The Netherlands Cancer Institute
Erectile Dysfunction Following Radical Prostatectomy
PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)
The PEHAB-II study is prospective, randomized trial designed to assess the effect of two different rehabilitation strategies on the recovery of erectile function in nerve sparing prostatectomy patients.
- Trial name
- PEHAB-II (NCT06875258)
- Testing
- Sildenafil, Erectile vacuum device
- Where
- 3 sites in Netherlands
- Volunteers
- 198 people
- Sponsor
- The Netherlands Cancer Institute
Melanoma Stage III, Melanoma Stage IV
Neo-adjuvant T-VEC + Nivolumab Combination Therapy for Resectable Early Metastatic (stage IIIB/C/D-IV M1a) Melanoma with Injectable Disease
Currently, standard treatment options available for Stage III melanoma include locoregional management (i.e. surgery) or systemic treatment (adjuvant to surgery or primarily in the case of unresectable disease).
- Trial name
- NIVEC (NCT04330430)
- Testing
- T-VEC
- Where
- Netherlands
- Volunteers
- 24 people
- Sponsor
- The Netherlands Cancer Institute
Melanoma Stage III, Melanoma Stage IV
FMT to Convert Response to Immunotherapy
In this study the aim is to investigate whether transfer of the microbiota of either responder or non-responder patients via fecal microbiotica transplantation (FMT) can convert the response to immunotherapy in immune checkpoint…
- Trial name
- NCT05251389
- Testing
- Fecal microbiota transplantation
- Where
- Netherlands
- Volunteers
- 24 people
- Sponsor
- The Netherlands Cancer Institute
Malignant Melanoma Stage III
Multicenter Phase 1b Trial Testing the Neoadjuvant Combination of Domatinostat, Nivolumab and Ipilimumab in IFN-gamma Signature-low and IFN-gamma Signature-high RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma
DONIMI is a phase 1b trial testing the combination of domatinostat + nivolumab or nivolumab monotherapy in IFN-gamma signature high patients and of domatinostat + nivolumab or domatinostat + nivolumab + ipilimumab in IFN-gamma…
- Trial name
- DONIMI (NCT04133948)
- Testing
- Domatinostat, Nivolumab, Ipilimumab
- Where
- 2 sites in Australia, Netherlands
- Volunteers
- 44 people
- Sponsor
- The Netherlands Cancer Institute
Metastatic Melanoma
Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma
In this randomized controlled phase III study the investigators will evaluate whether TIL infusion preceded by non-myeloablative chemotherapy and followed by high dose bolus interleukin-2 can result in an improved progression…
- Trial name
- TIL (NCT02278887)
- Testing
- Translational research, Cyclophosphamide, Fludarabine
- Where
- 2 sites in Denmark, Netherlands
- Volunteers
- 168 people
- Sponsor
- The Netherlands Cancer Institute
Urothelial Carcinoma
Improve Checkpoint-blockade Response in Advanced Urothelial Cancer
This trial will include metastatic urothelial carcinoma patients who progressed during or after treatment with anti-PD(L)1 therapy and have been treated by a platinum-containing regimen, or are cisplatin-ineligible.
- Trial name
- ICRA (NCT03871036)
- Testing
- Tremelimumab, Durvalumab, Paclitaxel
- Where
- Netherlands
- Volunteers
- 53 people
- Sponsor
- The Netherlands Cancer Institute
Urothelial Carcinoma
Neo-Adjuvant Bladder Urothelial Carcinoma COmbination-immunotherapy
In cohort 1 of this study, we used an attenuated schedule of neoadjuvant ipilimumab and nivolumab. In the multicenter extension (cohort 2), 30 patients were randomized between two neoadjuvant treatment schemes, both based upon an…
- Trial name
- NABUCCO (NCT03387761)
- Testing
- Ipilimumab, Nivolumab
- Where
- 3 sites in Netherlands
- Volunteers
- 54 people
- Sponsor
- The Netherlands Cancer Institute
Urothelial Carcinoma
Pre-operative Immunotherapy in Stage II-III Urothelial Cancer
This is a phase 1b feasibility study of pre-operative immunotherapy in PD-L1 positive resectable stage II-III urothelial cancer patients. This study can be adapted or expanded based on the results obtained.
- Trial name
- TURANDOT (NCT04871594)
- Testing
- Nivolumab
- Where
- 2 sites in Netherlands
- Volunteers
- 15 people
- Sponsor
- The Netherlands Cancer Institute
Colorectal Neoplasms, Floxuridine
Induction Treatment for Initially Unresectable Colorectal Liver Metastases: Combined Hepatic Arterial Infusion Pump Therapy With Systemic Therapy
The goal of this randomized clinical trial is to investigate induction treatment with Hepatic Arterial Infusion Pump therapy combined with systemic therapy (HAIP-SYST) in chemotherapy-naive patients with unresectable colorectal…
- Conditions
- Colorectal Neoplasms, Floxuridine, Liver Metastases, Vascular Access Device
- Trial name
- PUMP-IT RCT (NCT06857773)
- Testing
- Intra arterial infusion Floxuridine (FUDR) combined with systemic therapy, Hepatic arterial infusion pump (HAIP), Systemic therapy (standard of care)
- Where
- Netherlands
- Volunteers
- 306 people
- Sponsor
- The Netherlands Cancer Institute
Neuroendocrine Tumors, Neuroendocrine Tumor Grade 1
Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial
According to current guidelines, patients have to withhalt long-acting somatostatin analogues (LA-SSA) for 4-6 weeks prior to every 177Lutetium-DOTATATE administration.
- Conditions
- Neuroendocrine Tumors, Neuroendocrine Tumor Grade 1, Neuroendocrine Tumor Grade 2, Neuroendocrine Neoplasm
- Trial name
- ATSA (NCT06855095)
- Testing
- Somatostatin analog
- Where
- Netherlands
- Volunteers
- 39 people
- Sponsor
- The Netherlands Cancer Institute
Head and Neck Cancer
Adaptive Radiation Treatment for Head and Neck Cancer
This Phase III trial aims to: Explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN.
- Trial name
- ARTFORCE (NCT01504815)
- Testing
- cisplatinum, Conventional radiotherapy, Adaptive radiotherapy
- Where
- 9 sites in France, Netherlands and 3 more
- Volunteers
- 268 people
- Sponsor
- The Netherlands Cancer Institute
Pancreatic Cancer, Colorectal Cancer
Combination Therapy of RMC-4630 and LY3214996 in Metastatic KRAS Mutant Cancers
This is a Phase I/Ib study in which the safety of the combination therapy of RMC-4630 and LY3214996 in the treatment of KRAS mutant cancers will be studied.
- Conditions
- Pancreatic Cancer, Colorectal Cancer, Non-small Cell Lung Cancer, KRAS Mutation-Related Tumors
- Trial name
- SHERPA (NCT04916236)
- Testing
- RMC-4630, LY3214996
- Where
- Netherlands
- Volunteers
- 24 people
- Sponsor
- The Netherlands Cancer Institute
Patients With Non-small-cell Lung Cancer
Feasibility of Primer Shot Radiotherapy for Non-small Cell Lung Cancer - PRIMER
Intro/rationale: Radiotherapy employs uniform, equally spaced weekday fractions that do not account for changes in tumor radiosensitivity.
- Trial name
- PRIMER (NCT06528743)
- Testing
- RT (5x6 Gy) to the primary tumor and, if indicated, to lymph node and/or distant metastases.
- Where
- Netherlands
- Volunteers
- 34 people
- Sponsor
- The Netherlands Cancer Institute
Melanoma
Intradermal Ipilimumab and Nivolumab in High Risk Stage II Melanoma
This open label, single country trial will test if local injection of low-dose ipilimumab and nivolumab, is safe and reduces the sentinel node positivity in high-risk stage II melanoma patients.
- Trial name
- MARIANE (NCT06240143)
- Testing
- Ipilimumab, Nivolumab
- Where
- 6 sites in Netherlands
- Volunteers
- 96 people
- Sponsor
- The Netherlands Cancer Institute
Stage III NSCLC
Assess the Safety of Immunotherapy Induction With Tremelimumab and Durvalumab Prior to Chemoradiotherapy and/or Resection in the Treatment
A Phase Ib, Open-label, Single-center study to assess the safety of cancer-immunotherapy induction with Tremelimumab and Durvalumab prior to Chemoradiotherapy in the treatment of locally advanced NSCLC.
- Trial name
- Induction (NCT04287894)
- Testing
- Durvalumab, Tremelimumab, Pemetrexed
- Where
- Netherlands
- Volunteers
- 18 people
- Sponsor
- The Netherlands Cancer Institute