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Vaccination against cOvid In CancEr

To assess immune response and adverse events after administration of one approved vaccine against COVID-19 in patients with cancer treated with immunotherapy and/or chemotherapy

A Phase 1a/1b Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies

This first-in-man study will investigate the safety and tolerability as well as establish a recommended dose of INCB081776 as a monotherapy (Part 1) and then in combination with INCMGA00012 (Part 2) in participants with advanced malignancies. During…

Safety and feasibility of the use of cryoablation in patients with brain neoplasm

This study is performed to investigate the safety and feasibility of cryoablation during operation in adults in several brain tumors like gliomas, meningiomas, and brain metastasis. The primary objective is to assess safety in terms of complications…

A Phase 1, Open-Label, multicenter Study of INCA00186 as monotherapy or in combination with immunotherapy in participants with advanced solid tumors

The primary objective is to evaluate the safety, tolerability, and doselimiting toxicities, and determine the recommended dose for expansionof INCA00186 as monotherapy and of combination treatments of INCA00186 with retifanlimab and/or INCB106385 in…

A Phase 1/2 Randomized, Umbrella Study to Evaluate the Safety and Efficacy of Pembrolizumab Plus Enfortumab Vedotin (EV) in Combination With Investigational Agents Versus Pembrolizumab Plus EV, as First-Line Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04B

This study has been transitioned to CTIS with ID 2023-506385-30-00 check the CTIS register for the current data. Primary Part 1:-To evaluate ORR in participants treated with MK-4280A plus EV (Arm A), MK-7684A plus EV (Arm B), and pembrolizumab plus…

Phase III study assessing the *best of* radiotherapy compared to the *best of* surgery (trans-oral surgery (TOS)) in patients with T1-T2, N0-N1 oropharyngeal, supraglottic carcinoma and with T1, N0 hypopharyngeal carcinoma

The main objective of the study is to assess and compare the patient-reported swallowing function over the first year after randomization to either IMRT or TOS among patients with early stage OPSCC, SGSCC and HPSCC.

EPIK-P2: A Phase II double-blind study with an upfront, 16-week randomized, placebo-controlled period, to assess the efficacy, safety and pharmacokinetics of alpelisib (BYL719) in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS)

This study has been transitioned to CTIS with ID 2023-508530-34-00 check the CTIS register for the current data. Primary objective:* To demonstrate the efficacy of alpelisib as measured by the proportion of participants randomized to alpelisib with…

An open label pilot study of [18F]AlF-RESCA-IL2 (Interleukin-2 PET tracer) for positron emission tomography imaging in patients treated with immune checkpoint inhibitors

Primary objectives:• To evaluate safety of repeat doses of [18F]AlF-RESCA-IL2.• To evaluate tumour uptake of [18F]AlF-RESCA-IL2 in patients with cancer.• To evaluate whole body distribution of [18F]AlF-RESCA-IL2 in cancer patients.Secondary…

Robot-Assisted Cervical Esophagectomy: a safety and feasibility multicenter trial

To assess the safety and feasibility of performing a robot-assisted cervical esophagectomy (RACE) for patients with esophageal cancer.

A 2-part phase III randomized, open label, multicenter study of LGX818 plus MEK162 versus vemurafenib and LGX818 monotherapy in patients with unresectable or metastatic BRAF V600 mutant melanoma

To determine whether treatment with LGX818 plus MEK162 prolongs progression free survival (PFS) compared with vemurafenib, and/or whether treatment with LGX818 prolongs PFS compared with vemurafenib in patients with BRAF V600 mutant locally advanced…

Feasibility of CBCT-guided online adaptive radiotherapy

The primary objective is to test the feasibility of daily adaptive radiotherapy plan based on the cone beam CT. The expectance is that this new technique will make the radiotherapy more precise which results in less side effects or patient could…

A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy in Participants With Selected Advanced Solid Tumors

This study has been transitioned to CTIS with ID 2024-512822-28-00 check the CTIS register for the current data. The primary objective of this study is to evaluate the safety and tolerability and determine the MTD and RDE(s) of INCB123667 as…

A Phase 1, Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MK-4464 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced / Metastatic Solid Tumors

This study has been transitioned to CTIS with ID 2023-504855-28-00 check the CTIS register for the current data. To determine the safety and tolerability and to establish a preliminary RP2D and/or an MTD or an MAD of MK-4464 administered via IV…

Safe Stop IPI-NIVO Trial: Early discontinuation of nivolumab upon achieving a (confirmed) complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab

This study has been transitioned to CTIS with ID 2024-516938-34-00 check the CTIS register for the current data. The primary objective of this study is to evaluate the rate of ongoing response at 12 months after start of treatment in patients with…

A Phase 2, Multicenter, Multi Arm, Study to Evaluate MK-1308A (Coformulated
quavonlimab (MK-1308)/pembrolizumab) Versus Other Treatments in
Participants with Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient
(dMMR) Stage IV Colorectal Cancer: (MK-1308A-008)

This study has been transitioned to CTIS with ID 2022-502100-70-00 check the CTIS register for the current data. The aim of this research is:1. To test the safety of MK-1308A, MK-4280A, MK-7684A and MK 4830 + pembrolizumab against pembrolizumab as…

A first-in-human, open-label, dose escalation followed by dose expansion phase I/IIa trial to evaluate the safety, preliminary efficacy and pharmacokinetics of intratumoral CyPep-1 monotherapy and in combination with pembrolizumab in patients with advanced solid cancers.

The primary objectives are:- To evaluate the safety and tolerability of IT administration of CyPep-1 as monotherapy and in combination with pembrolizumab.- To identify the recommended phase II dose (RP2D) of CyPep-1 as monotherapy and in combination…

Administration of immune checkpoint inhibitors through an elastomeric pump. A patient preference study and cost analysis.

The primary objective of this study is to evaluate the patient preference for either ICI-B or ICI-P. Secondary objectives are: to assess patient satisfaction with ICI-B and ICI-P, to establish the safety of ICI-B and ICI-P to establish the…

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Navitoclax in Combination with Ruxolitinib Versus Ruxolitinib in Subjects with Myelofibrosis

Primary objective: To evaluate the effect of navitoclax in combination with ruxolitinib on splenomegaly response when compared to ruxolitinib in subjects with myelofibrosis.Secondary objectives:• To evaluate the effect of navitoclax in combination…

Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer
(HER2CLIMB-02)

This study has been transitioned to CTIS with ID 2024-514733-38-00 check the CTIS register for the current data. Primary* Compare progression-free survival (PFS) by investigator assessment per Response Evaluation Criteria inSolid Tumors (RECIST) v1.…

Validation of ICG-99mTc-nanoscan as hybrid tracer for sentinel node biopsy

This study has been transitioned to CTIS with ID 2024-519351-28-00 check the CTIS register for the current data. Cross validation of the hybrid tracer ICG 99 Tc Nanoscan with respect to 99m Tc Nanoscan for the determination. In particular the…