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Melanoma clinical trials

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NCT ID: NCT04901988 Terminated - Melanoma (Skin) Clinical Trials

Circulating Tumour DNA guidEd Therapy for Stage IIB/C mElanoma After surgiCal resecTION

DETECTION
Start date: November 8, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The trial is looking for new and better ways to treat melanoma, an aggressive type of skin cancer. Having surgery to remove the melanoma will cure the majority of patients with early stage disease. However, a small percentage of these patients will go on to develop further disease, which may spread to other places in their body. Currently, patients who have been cured of melanoma will have appointments in clinic to check that further disease has not developed or returned and some may also receive regular scans. The trial team has developed a blood test that tells us whether cancer cells are still present or is becoming active after a patient has been 'cured' of melanoma, even if a scan looks normal. The test looks for pieces of DNA in the blood that are known to have come from the cancer, which we call 'circulating tumour DNA', or ctDNA. Patients who have ctDNA in their blood have an extremely high chance of the cancer returning. By using the blood test that we have developed we think that we can identify patients earlier than normal. We think that some of the treatments that are used when melanoma cancer has spread may benefit patients at this earlier stage. We want to see if these patients with ctDNA in their blood, who have a higher risk of their cancer returning or spreading, and receive treatment early have a better response to their cancer compared to those patients who receive treatment when their cancer has returned and it can be seen on a scan. This could mean we would be able to offer patients earlier treatment in the future using just a blood test rather than a scan, while also providing reassurance to those patients that do not have ctDNA in their blood that they do not need treatment and their cancer is not returning.

NCT ID: NCT04899921 Terminated - Melanoma Clinical Trials

Troriluzole or Placebo Plus Ipi Plus Nivo in Mel Brain Mets

Start date: June 30, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this research is to test the safety and effectiveness of the investigational combination of Troriluzole, ipilimumab, and nivolumab, and to learn whether this combination works in treating melanoma that has spread to the brain.

NCT ID: NCT04894994 Terminated - Advanced Melanoma Clinical Trials

FLX475 in Combination With Ipilimumab in Advanced Melanoma

Start date: September 3, 2021
Phase: Phase 2
Study type: Interventional

This clinical trial is a Phase 2, open-label study to determine the anti-tumor activity of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed cell death ligand 1 (anti-PD-L1) agent. The study will be conducted starting with a safety run-in portion in which 6 eligible subjects will be enrolled and treated for at least one 3-week cycle to determine if the safety profile of FLX475+ipilimumab is acceptable to complete enrollment of the approximately 20-subject study.

NCT ID: NCT04879017 Terminated - Clinical trials for Metastatic Uveal Melanoma

FHD-286 in Subjects With Metastatic Uveal Melanoma

Start date: May 11, 2021
Phase: Phase 1
Study type: Interventional

This Phase 1, multicenter, open-label, dose escalation and expansion study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-286 oral monotherapy in subjects with metastatic Uveal Melanoma (UM).

NCT ID: NCT04834973 Terminated - Melanoma Clinical Trials

A Trial of Tigilanol Tiglate in Combination With Pembrolizumab in Stage IIIB to IV M1c-melanoma

Start date: May 7, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase Ib/IIa, multicentre, open label, dose-escalation study to evaluate the safety, tolerability, and preliminary effectiveness of intratumoural tigilanol tiglate in combination with intravenous pembrolizumab in adult patients with unresectable, Stage IIIB to IV M1c melanoma.

NCT ID: NCT04809805 Terminated - Clinical trials for Metastatic Melanoma and Other Solid Tumors

A Study to Learn How Safe BAY2666605 is, How it Affects the Body, How it Moves Into, Through and Out of the Body, the Maximum Amount That Can be Given and Its Action Against Tumors in Adult Participants With Skin Cancer That Has Spread to Other Parts of the Body and Other Types of Advanced Cancer

Start date: April 15, 2021
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat people who have advanced cancer. In this study researchers want to learn more about a new substance called BAY2666605. BAY2666605 triggers the formation of a complex of two proteins called SLFN12 and PDE3A. This complex drive cancer cells into cell death by a mechanism called apoptosis. The complex is only formed in the cancers which contain both proteins. This study is done in adult patients who have certain types of advanced cancers that cannot be cured by drugs that are currently available. The cancer types include skin cancer that has spread to other parts of the body and cancer that started in the bones or soft tissue, the ovaries, or the brain. Patients with these cancers are only included if the cells of the patient's cancer contain the building plan to produce SLFN12-phosphodiesterase 3A (PDE3A) complex. To confirm this, a specific test is performed with the cancer cells. The researchers will study how BAY2666605 moves into, through and out of the body. Researchers will try to find the best dose that can be given, how safe BAY2666605 is and how it affects the body. Researchers will also study the action of BAY2666605 against the cancer. Part A will include about 36 participants and up to another 12 participants. Part B will include about 41 participants. All of the participants will take BAY2666605 by mouth as either a liquid or as tablets. During the study, the participants will take the treatment in 4 week periods called cycles. In each cycle, the participants will in general take BAY2666605 once daily. The participants may also be asked to do overnight fasting before the intake of substance and to have standard high-fat, high-calorie breakfast on some days before taking the dose. These 4 week cycles will be repeated throughout the trial. The participants can take BAY2666605 until their cancer gets worse, until they have medical problems, or until they leave the trial. Participants will have around 18 visits in each cycle. Some of the visits can also be done via Phone. During the trial, the study team will take blood and urine samples, do physical examinations and check the participants' heart health using an electrocardiogram (ECG) and an ultrasound of the heart. The study team will also take pictures of the participants' tumors using CT or MRI scans. The study team will ask how the participants are feeling, if participants have any medical problems or if participants are taking any other medicine. About 1 month and 3 months after the last dose, the participants will have another visit and a phone call respectively where participants will be checked for and asked about medical problems. The researchers will then contact the participants every 3 months until the trial ends.

NCT ID: NCT04785365 Terminated - Melanoma Clinical Trials

Long-Term Follow-Up Study of Patients Receiving ATL001

Start date: June 1, 2022
Phase: Phase 2
Study type: Interventional

This is an Open-Label, Multi-Centre Phase II study to evaluate the long-term safety and clinical activity of ATL001, previously administered intravenously to patients in Study ATX-NS-001 (NCT04032847) or Study ATX-ME-001 (NCT03997474).

NCT ID: NCT04762225 Terminated - Melanoma Clinical Trials

RPTR-168 in Patients With Human Papillomavirus Strain 16 (HPV-16) E6/E7 Positive Tumors and Melanoma

Start date: May 10, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of escalating doses of RPTR-168 as a monotherapy in patients with HPV-16 E6/E7 positive tumors (HNSCC, cervical) and melanoma.

NCT ID: NCT04688749 Terminated - Melanoma (Skin) Clinical Trials

Use of Electrical Impedance Spectroscopy (EIS) for Early Diagnosis of Skin Damage

DermaSense
Start date: July 17, 2019
Phase:
Study type: Observational

The purpose of this clinical study is to evaluate if the DermaSense prototype EIS scanner can provide medical decision support which can complement dermoscopy-based identification of the disease at time of biopsy decision.

NCT ID: NCT04663126 Terminated - Melanoma Clinical Trials

Feasibility of IV Tc-99m-tilmanocept for Imaging of M2-like TAMs in Metastatic Melanoma

Tilmanocept
Start date: February 1, 2021
Phase: Early Phase 1
Study type: Interventional

This study in 20 patients is designed as a monocentric, open-label and uncontrolled, exploratory pilot study. Patients diagnosed with advanced melanoma (stage III-IV) and scheduled for anti-PD-1 immunotherapy will be recruited for this project. Patients will receive IV 250 µg Tilmanocept, labelled with 370 MBq of Tc-99m (bolus injection) according to the Navidea's protocol in our GMP certified radiopharmaceutical unit, before the first cycle of clinically scheduled immunotherapy. Scintigraphy images will be acquired dynamically from time of injection to +30 minutes. Quantitative SPECT/CT (xSPECT/CT, Siemens Symbia Intevo, Erlangen, Germany) imaging will be performed up to 1 hour p.i. to evaluate hyperaemia, and up to 3 hours p.i. to image and measure the CD206 receptor uptake. The data of the scans will be compared to immunohistochemistry results from biopsy staining for TAMs and M2-like TAMs and retrospectively with response to the immunotherapy to determine any correlation between M2-like TAMs and treatment response. For the planned retrospective comparison we will use the FDG - PET/CT data that is done after the immunotherapy as standard of care. We will analyse the lesion size and FDG - uptake in standard of care PET/CT of CD206+ and CD206 negative lesions in Tilmanocept SPECT/CT before and after immunotherapy to determine any correlation between CD206 related uptake and treatment response.