Clinical Trials – Melanoma Research Victoria https://melanomaresearchvic.com.au Thu, 21 Jan 2021 04:57:34 +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 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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World first melanoma success in Australia prompts new trial https://melanomaresearchvic.com.au/world-first-melanoma-success-in-australia-prompts-new-trial Wed, 20 Jan 2021 06:04:55 +0000 https://melanomaresearchvic.com.au/?p=16239 A Sydney man who was seriously ill with advanced melanoma has made a remarkable recovery after receiving a drug reserved for breast and ovarian cancer.

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Source: 9NEWS, January 2021

A Sydney man who was seriously ill with advanced melanoma has made a remarkable recovery after receiving a drug reserved for breast and ovarian cancer.
Charles Hanna had exhausted all treatments for his cancer, but tumours in his upper abdomen have now vanished.
His world-first case has prompted the Melanoma Institute to run a new clinical trial.

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Sydney man recovers from advanced melanoma in unconventional treatment https://melanomaresearchvic.com.au/sydney-man-recovers-from-advanced-melanoma-in-unconventional-treatment Tue, 19 Jan 2021 05:28:50 +0000 https://melanomaresearchvic.com.au/?p=16233 A Sydney man has recovered from advanced melanoma thanks to a drug usually used for breast and ovarian cancer, prompting the Melanoma Institute to run a new clinical trial.

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Source: 9NEWS, January 2021

A Sydney man has recovered from advanced melanoma thanks to a drug usually used for breast and ovarian cancer, prompting the Melanoma Institute to run a new clinical trial.

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ONCOS-102 Plus Pembrolizumab Induces Impressive Responses in Anti-PD1–Refractory Melanoma https://melanomaresearchvic.com.au/oncos-102-plus-pembrolizumab-induces-impressive-responses-in-anti-pd1-refractory-melanoma Fri, 15 Jan 2021 12:37:03 +0000 https://melanomaresearchvic.com.au/?p=16206 The combination of ONCOS-102 plus pembrolizumab (Keytruda) demonstrated promising objective responses as treatment of patients with anti-PD1–refractory malignant melanoma in a phase 1 clinical trial, announced Targovax in a press release.

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Source: Targeted Oncology, December 2020

The combination of ONCOS-102 plus pembrolizumab (Keytruda) demonstrated promising objective responses as treatment of patients with anti-PD1–refractory malignant melanoma in a phase 1 clinical trial, announced Targovax in a press release.

Tumor responses were observed in 7 of 20 evaluable patients, which translated to an objective response rate (ORR) of 35% by RECIST 1.1 criteria.

Multiple examples of responses were observed in non-injected lesions as well, including 2 patients where a non-injected lesion disappeared completely.

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Targovax announces impressive objective responses as well as effects on non-injected lesions in ONCOS-102 trial in anti-PD1 refractory melanoma patients https://melanomaresearchvic.com.au/targovax-announces-impressive-objective-responses-as-well-as-effects-on-non-injected-lesions-in-oncos-102-trial-in-anti-pd1-refractory-melanoma-patients Wed, 13 Jan 2021 12:13:54 +0000 https://melanomaresearchvic.com.au/?p=16194 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, today announces that the combination of ONCOS-102 and pembrolizumab (Keytruda) has demonstrated 35% best objective response rate (ORR) in anti-PD1 refractory malignant melanoma.

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Source: CISION PR Newswire, December 2020

Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, today announces that the combination of ONCOS-102 and pembrolizumab (Keytruda) has demonstrated 35% best objective response rate (ORR) in anti-PD1 refractory malignant melanoma.

In this two-part, open label phase 1 trial the combination of ONCOS-102 and the anti-PD1 checkpoint inhibitor (CPI) pembrolizumab has been tested in patients with advanced, unresectable melanoma who have had disease progression despite treatment with anti-PD1 CPI.

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Immune-Boosting Components Double the Effectiveness of Melanoma Vaccine Candidate in Phase II Trial https://melanomaresearchvic.com.au/immune-boosting-components-double-the-effectiveness-of-melanoma-vaccine-candidate-in-phase-ii-trial Wed, 23 Dec 2020 03:49:52 +0000 https://melanomaresearchvic.com.au/?p=16094 A vaccine created to prevent the recurrence of the deadly skin cancer melanoma is about twice as effective when patients also receive two components that boost the number and effectiveness of immune system dendritic cells (DCs), according to the results of a Phase II clinical trial published in Nature Cancer.

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Source: Genetic Engineering & Biotechnology News, November 2020

A vaccine created to prevent the recurrence of the deadly skin cancer melanoma is about twice as effective when patients also receive two components that boost the number and effectiveness of immune system dendritic cells (DCs), according to the results of a Phase II clinical trial published in Nature Cancer.

Researchers at the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, working with colleagues at the National Cancer Institute-funded Cancer Immunotherapy Trials Network (CITN) based at the Fred Hutchinson Cancer Research Center, tested the approach in patients treated using CDX-1401, a vaccine that is designed to target dendritic cells, and which is composed of an antigen found in melanoma bound to an antibody to increase the chances of binding with dendritic cells.

They found that addition of the small molecule, Flt3L (fms-like tyrosine kinase 3 ligand), which increases the number of dendritic cells, boosted the vaccine’s effectiveness at triggering the production of antibodies and T cells that can later fight melanoma.

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Longer follow-up confirms recurrence-free survival benefit of adjuvant pembrolizumab in high-risk stage III melanoma: Updated results from the EORTC 1325-MG/KEYNOTE-054 trial https://melanomaresearchvic.com.au/longer-follow-up-confirms-recurrence-free-survival-benefit-of-adjuvant-pembrolizumab-in-high-risk-stage-iii-melanoma-updated-results-from-the-eortc-1325-mg-keynote-054-trial Thu, 17 Dec 2020 06:57:47 +0000 https://melanomaresearchvic.com.au/?p=16078 In this phase III double-blind European Organisation for Research and Treatment of Cancer (EORTC) 1325/KEYNOTE-054 trial, researchers sought to assess pembrolizumab vs placebo in patients with resected high-risk stage III melanoma.

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Source: MDLinx, November 2020

In this phase III double-blind European Organisation for Research and Treatment of Cancer (EORTC) 1325/KEYNOTE-054 trial, researchers sought to assess pembrolizumab vs placebo in patients with resected high-risk stage III melanoma.

In total, 1,019 patients with complete lymph node dissection of American Joint Committee on Cancer Staging Manual (seventh edition; AJCC-7), stage IIIA (at least one lymph node metastasis > 1 mm), IIIB, or IIIC (without in-transit metastasis) cutaneous melanoma were assigned randomly to get pembrolizumab at a flat dose of 200 mg (n = 514) or placebo (n = 505) every 3 weeks for 1 year or until disease recurrence or unacceptable toxicity.

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Phase 3 Study Shows Statistically Significant Survival With Tebentafusp in Metastatic Uveal Melanoma https://melanomaresearchvic.com.au/phase-3-study-shows-statistically-significant-survival-with-tebentafusp-in-metastatic-uveal-melanoma Tue, 15 Dec 2020 06:13:22 +0000 https://melanomaresearchvic.com.au/?p=16066 Overall survival (OS) was statistically significantly improved with tebentafusp compared with investigator’s choice of therapy as treatment of patients with metastatic uveal melanoma in the phase 3 IMCgp100-202 study (NCT03070392), Immunocore announced in a press release.

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Source: Targeted Oncology, November 2020

Overall survival (OS) was statistically significantly improved with tebentafusp compared with investigator’s choice of therapy as treatment of patients with metastatic uveal melanoma in the phase 3 IMCgp100-202 study (NCT03070392), Immunocore announced in a press release.

The novel bispecific protein is made of a soluble T-cell receptor that is fused to an anti-CD3 immune-effector function, and it targets gp100 specifically, an antigen expressed in melanocytes and melanoma.

Tebentafusp is the first agent coming out of the ImmTAC technology platform at Immunocore that is designed to redirect and activate T-cells to identify and kill tumor cells.

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A Phase II/III Study of Immunotherapy with Nivolumab, Ipilimumab, and GM-CSF in Patients with Advanced Melanoma https://melanomaresearchvic.com.au/a-phase-ii-iii-study-of-immunotherapy-with-nivolumab-ipilimumab-and-gm-csf-in-patients-with-advanced-melanoma Tue, 15 Dec 2020 06:10:06 +0000 https://melanomaresearchvic.com.au/?p=16064 Nivolumab and ipilimumab are immunotherapy drugs used to treat advanced melanoma. They can be used individually or together.

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Source: Memorial Sloan Kettering Cancer Center

Nivolumab and ipilimumab are immunotherapy drugs used to treat advanced melanoma. They can be used individually or together.

In this study, researchers are assessing the safety and effectiveness of combining nivolumab and ipilimumab immunotherapy with another drug used in cancer care called GM-CSF (sargramostim) in patients with advanced melanoma.

GM-CSF signals the body to make more white blood cells.

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