Clinical Trials – Melanoma Research Victoria https://melanomaresearchvic.com.au Thu, 08 Apr 2021 07:43:35 +0000 en-US hourly 1 https://melanomaresearchvic.com.au/wp-content/uploads/2017/12/cropped-favicon-32x32.png Clinical Trials – Melanoma Research Victoria https://melanomaresearchvic.com.au 32 32 Dabrafenib plus trametinib improves relapse-free survival time in melanoma https://melanomaresearchvic.com.au/dabrafenib-plus-trametinib-improves-relapse-free-survival-time-in-melanoma Thu, 08 Apr 2021 07:31:23 +0000 https://melanomaresearchvic.com.au/?p=16561 Patients with a stage III melanoma mutation treated with dabrafenib plus trametinib had longer restricted mean survival times compared with placebo, according to an analysis of a phase 3 trial presented at Maui Derm for Dermatologists.

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Source: Healio, February 2021

Patients with a stage III melanoma mutation treated with dabrafenib plus trametinib had longer restricted mean survival times compared with placebo, according to an analysis of a phase 3 trial presented at Maui Derm for Dermatologists.

“Kaplan-Meier and Cox regression analyses have been used to assess adjuvant treatment effects based on time-to-event analyses,” John M. Kirkwood, MD, and colleagues wrote in the poster. “Unfortunately, these statistical methods do not account for nonproportional hazards and the fact that some patients never experience relapse.”

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Pathological response to neoadjuvant therapy correlates to RFS, OS in stage III melanoma https://melanomaresearchvic.com.au/pathological-response-to-neoadjuvant-therapy-correlates-to-rfs-os-in-stage-iii-melanoma Tue, 16 Mar 2021 07:37:31 +0000 https://melanomaresearchvic.com.au/?p=16495 Pathological response should be an early surrogate endpoint for clinical trials of neoadjuvant therapy for melanoma, according to results of a pooled analysis published in Nature Medicine.

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Source: Healio, February 2021

Pathological response should be an early surrogate endpoint for clinical trials of neoadjuvant therapy for melanoma, according to results of a pooled analysis published in Nature Medicine.

Pathological complete response (pCR) also should be a new benchmark for drug development and approval, study authors concluded.

“Neoadjuvant systemic therapy has the potential to reduce tumor burden to facilitate and likely reduce the extent of surgical resection for stage III melanoma, as well as provide prognostic information to allow personalized follow-up and alternative adjuvant therapy in poor-prognosis patients,” Alexander Menzies, BSc(Med), MBBS(Hons), FRACP, PhD, medical oncologist and associate professor of melanoma medical oncology at Melanoma Institute Australia, told Healio.

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NeoVax Demonstrates Long-Lasting Durable Responses in Melanoma https://melanomaresearchvic.com.au/neovax-demonstrates-long-lasting-durable-responses-in-melanoma Mon, 08 Mar 2021 07:25:00 +0000 https://melanomaresearchvic.com.au/?p=16479 Neoantigen long peptide vaccines (NeoVax) continued to show durable T-cell responses in patients with high-risk melanoma that persisted 4 years after initial vaccination, highlighting the ability of personalized cancer vaccines to provide long-term control against some cancers, according to results of a phase 1 study (NCT01970358) published in Nature Medicine.1,2

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Source: OncLive, February 2021

Neoantigen long peptide vaccines (NeoVax) continued to show durable T-cell responses in patients with high-risk melanoma that persisted 4 years after initial vaccination, highlighting the ability of personalized cancer vaccines to provide long-term control against some cancers, according to results of a phase 1 study (NCT01970358) published in Nature Medicine.1,2

In the small study of 8 patients who had previously received surgery for advanced melanoma, and were considered to be at high-risk of recurrence, NeoVax was administered at a median 18 weeks after resection.

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Cancer vaccine helped keep melanoma under control for years in small study https://melanomaresearchvic.com.au/cancer-vaccine-helped-keep-melanoma-under-control-for-years-in-small-study Wed, 03 Mar 2021 07:47:26 +0000 https://melanomaresearchvic.com.au/?p=16453 A personalized “cancer vaccine” may help keep a deadly form of skin cancer from growing for years, a small new study in humans suggests.

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Source: LIve Science, January 2021

A personalized “cancer vaccine” may help keep a deadly form of skin cancer from growing for years, a small new study in humans suggests.

Unlike vaccines that prevent infections, such as measles and influenza, cancer vaccines are a form of immunotherapy that take down cancer cells that already exist.

The vaccines train immune cells, called T cells, to better recognize cancer and target it for destruction, while sparing healthy cells in the body.

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Melanoma Vaccine from NeoVox Shows Anti-Tumor Response Four Years Later https://melanomaresearchvic.com.au/melanoma-vaccine-from-neovox-shows-anti-tumor-response-four-years-later Wed, 03 Mar 2021 07:41:55 +0000 https://melanomaresearchvic.com.au/?p=16451 In encouraging news regarding melanoma therapy, researchers found that a personalized vaccine continues to keep cancer cells in check four years after patients received it.

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Source: Clinical OMICs, January 2021

In encouraging news regarding melanoma therapy, researchers found that a personalized vaccine continues to keep cancer cells in check four years after patients received it.

In a Phase 1 study among eight patients with advanced melanoma who received the NeoVax vaccine, after a median of four years, all of the patients were alive. Six patients had no signs of active disease.

Further, studies of patients’ T cells revealed they were still active against their originally targeted proteins on melanoma cells but also recognized others.

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Eganelisib/Nivolumab Combo Shows Positive Responses in Head and Neck Carcinoma, Melanoma https://melanomaresearchvic.com.au/eganelisib-nivolumab-combo-shows-positive-responses-in-head-and-neck-carcinoma-melanoma Tue, 02 Mar 2021 07:30:21 +0000 https://melanomaresearchvic.com.au/?p=16447 Positive response and disease control rates were observed in 2 separate studies when patients with head and neck squamous cell carcinoma (HNSCC) and melanoma received the combination of eganelisib (IPI-549), a selective PI3K-? inhibitor, and nivolumab (Opdivo).

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Source: Targeted Oncology, January 2021

Positive response and disease control rates were observed in 2 separate studies when patients with head and neck squamous cell carcinoma (HNSCC) and melanoma received the combination of eganelisib (IPI-549), a selective PI3K-γ inhibitor, and nivolumab (Opdivo).

In the first study, updated findings from an expansion cohort of the ongoing phase 1/1b MARIO-1 trial (NCT02637531), presented during the 35th Annual Meeting & Pre-Conference Programs of the Society for Immunotherapy of Cancer (SITC 2020)

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Avastin Plus Chemotherapy Improves Progression-Free and Overall Survival in Mucosal Melanoma https://melanomaresearchvic.com.au/avastin-plus-chemotherapy-improves-progression-free-and-overall-survival-in-mucosal-melanoma Fri, 26 Feb 2021 06:40:32 +0000 https://melanomaresearchvic.com.au/?p=16430 Avastin (bevacizumab) with carboplatin plus paclitaxel improved overall survival (OS) and progression-free survival (PFS) compared with carboplatin and paclitaxel alone in patients with metastatic mucosal melanoma, according to findings from a phase 2 study published in the Journal of Clinical Oncology.

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Source: Cure Today, January 2021

Avastin (bevacizumab) with carboplatin plus paclitaxel improved overall survival (OS) and progression-free survival (PFS) compared with carboplatin and paclitaxel alone in patients with metastatic mucosal melanoma, according to findings from a phase 2 study published in the Journal of Clinical Oncology.

“Mucosal melanoma is a highly vascularized tumor with an extremely poor prognosis,” the study authors wrote.

“The (Avastin with paclitaxel and carboplatin) protocol could be an alternative for the treatment of advanced (mucosal melanoma) in immunotherapies-ineligible or immunotherapies-failure population.”

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IDEAYA Biosciences Doses First Patient in a Phase 1 Combination Study of IDE196 and Crizotinib, a cMET Inhibitor https://melanomaresearchvic.com.au/ideaya-biosciences-doses-first-patient-in-a-phase-1-combination-study-of-ide196-and-crizotinib-a-cmet-inhibitor Tue, 26 Jan 2021 05:03:56 +0000 https://melanomaresearchvic.com.au/?p=16270 SOUTH SAN FRANCISCO, Calif., Jan. 5, 2021 /PRNewswire/ — IDEAYA Biosciences, Inc. (Nasdaq:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, announced First-Patient-In (FPI) in the Phase 1 combination study of IDE196 and crizotinib, a cMET inhibitor, in metastatic uveal melanoma (MUM).

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Source: PR Newswire, January 2021

SOUTH SAN FRANCISCO, Calif., Jan. 5, 2021 /PRNewswire/ — IDEAYA Biosciences, Inc. (Nasdaq:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, announced First-Patient-In (FPI) in the Phase 1 combination study of IDE196 and crizotinib, a cMET inhibitor, in metastatic uveal melanoma (MUM).

The clinical combination of IDE196 and crizotinib is being evaluated by IDEAYA in collaboration with Pfizer pursuant to a clinical trial collaboration and supply agreement.

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Ideaya Biosciences Begins Trial of IDE196, Xalkori in Uveal Melanoma Patients https://melanomaresearchvic.com.au/ideaya-biosciences-begins-trial-of-ide196-xalkori-in-uveal-melanoma-patients Mon, 25 Jan 2021 04:54:02 +0000 https://melanomaresearchvic.com.au/?p=16261 San Francisco-based Ideaya Biosciences on Tuesday said that it has dosed its first uveal melanoma patient in a clinical trial evaluating its PKC inhibitor IDE196 with Pfizer’s cMET inhibitor crizotinib (Xalkori).

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Source: genomeweb, January 2021

San Francisco-based Ideaya Biosciences on Tuesday said that it has dosed its first uveal melanoma patient in a clinical trial evaluating its PKC inhibitor IDE196 with Pfizer’s cMET inhibitor crizotinib (Xalkori).

Ideaya, which develops precision oncology drugs for patients selected using molecular diagnostics, is evaluating the IDE196-crizotinib combination in metastatic uveal melanoma patients following results from preclinical research demonstrating synergistic activity between the two agents.

Mick O’Quigley, Ideaya’s VP and head of development operations, said in a statement that the company decided to advance the combination to clinical trials based on translational research that included evaluation of cMET expression in samples from metastatic uveal melanoma patients.

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Philogen Announces the Completion of a Second Interim Analysis of Its Phase III Clinical Program With Nidlegy for the Treatment of Melanoma https://melanomaresearchvic.com.au/philogen-announces-the-completion-of-a-second-interim-analysis-of-its-phase-iii-clinical-program-with-nidlegy-for-the-treatment-of-melanoma Wed, 20 Jan 2021 06:22:47 +0000 https://melanomaresearchvic.com.au/?p=16241 Philogen S.p.A., a clinical-stage biotechnology company focused on antibody-based therapeutics, is pleased to announce that 50% of the expected events for the primary outcome analysis of the PIVOTAL study were reached in December 2020.

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Source: PR Newswire, January 2021

hilogen S.p.A., a clinical-stage biotechnology company focused on antibody-based therapeutics, is pleased to announce that 50% of the expected events for the primary outcome analysis of the PIVOTAL study were reached in December 2020.

In this phase III clinical trial, the effect of Nidlegy™ is evaluated in melanoma patients with locally advanced, fully resectable metastatic cancer, and at the time of the second interim analysis, had already recruited 149 out of the anticipated 214 patients (one additional patient was enrolled recently).

As a consequence, the second interim data analysis foreseen by the clinical protocol was carried out and submitted to the Data and Safety Monitoring Board of the study for their consideration.

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