Clinical Trials – Melanoma Research Victoria https://melanomaresearchvic.com.au Thu, 17 Sep 2020 07:53:11 +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 Adjuvant Nivolumab Plus Ipilimumab vs Nivolumab Alone in Resected Stage IV Melanoma With No Evidence of Disease https://melanomaresearchvic.com.au/adjuvant-nivolumab-plus-ipilimumab-vs-nivolumab-alone-in-resected-stage-iv-melanoma-with-no-evidence-of-disease Thu, 17 Sep 2020 07:41:55 +0000 https://melanomaresearchvic.com.au/?p=15622 In an interim analysis of the German phase II IMMUNED trial reported in The Lancet, Lisa Zimmer, MD, of University Hospital Essen, and colleagues found that adjuvant nivolumab plus ipilimumab and nivolumab alone significantly prolonged recurrence-free survival vs placebo in patients with resected stage IV melanoma and no evidence of disease.1 Severe treatment-related toxicity and […]

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Source: The ASCO Post, September 2020

In an interim analysis of the German phase II IMMUNED trial reported in The Lancet, Lisa Zimmer, MD, of University Hospital Essen, and colleagues found that adjuvant nivolumab plus ipilimumab and nivolumab alone significantly prolonged recurrence-free survival vs placebo in patients with resected stage IV melanoma and no evidence of disease.1 Severe treatment-related toxicity and treatment discontinuations were substantially more common with combination vs nivolumab treatment.

Study Details

In the multicenter, double-blind trial, 167 patients with no evidence of disease after surgery or radiotherapy were randomly assigned 1:1:1 between September 2015 and November 2018 to receive nivolumab at 1 mg/kg every 3 weeks plus ipilimumab at 3 mg/kg every 3 weeks for 4 doses, followed by nivolumab at 3 mg/kg every 2 weeks (n = 56), nivolumab at 3 mg/kg every 2 weeks plus placebo (n = 59), or double placebo (n = 52).

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Novel PKC Inhibitor Trial to Expand Its Cohort of Patients With Solid Tumors https://melanomaresearchvic.com.au/novel-pkc-inhibitor-trial-to-expand-its-cohort-of-patients-with-solid-tumors Wed, 12 Aug 2020 08:36:58 +0000 https://melanomaresearchvic.com.au/?p=15479 The FDA granted Fast Track designation to BDTX-189 for the treatment of adult patients with solid tumors harboring an allosteric HER2 mutation or an EGFR or HER2 exon 20 insertion who have progressed following previous treatment and for whom no satisfactory alternative treatments exist, Black Diamond Therapeutics announced in a press release.1

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Source: Targeted Oncology, July 2020

The FDA granted Fast Track designation to BDTX-189 for the treatment of adult patients with solid tumors harboring an allosteric HER2 mutation or an EGFR or HER2 exon 20 insertion who have progressed following previous treatment and for whom no satisfactory alternative treatments exist, Black Diamond Therapeutics announced in a press release.1

“While targeted therapies, such as kinase inhibitors, have transformed the treatment of cancer, only a small percentage of patients with metastatic cancer have tumors with genetic profiles that could make them eligible for an approved precision oncology medicine. The FDA’s decision to grant Fast Track designation is an important recognition of BDTX-189’s potential to treat patients with currently unaddressed oncogenic mutations in EGFR and HER2,” said David M. Epstein, PhD, president, and CEO of Black Diamond Therapeutic, in the press release.

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Investigators Present Updated Results of the OpACIN Trial for Melanoma https://melanomaresearchvic.com.au/investigators-present-updated-results-of-the-opacin-trial-for-melanoma Mon, 10 Aug 2020 13:39:53 +0000 https://melanomaresearchvic.com.au/?p=15463 Christian U. Blank, MD, PhD, medical oncologist in the Division of Immunology at the Netherlands Cancer Institute, discusses the most recent data from the phase 1b OpACIN trial (NCT02437279) of ipilimumab (Yervoy) and nivolumab (Opdivo) in patients with macroscopic stage III melanoma.

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Source: Targeted Oncology, July 2020

Christian U. Blank, MD, PhD, medical oncologist in the Division of Immunology at the Netherlands Cancer Institute, discusses the most recent data from the phase 1b OpACIN trial (NCT02437279) of ipilimumab (Yervoy) and nivolumab (Opdivo) in patients with macroscopic stage III melanoma.

This was the first trial in the melanoma setting that tested checkpoint inhibition. Blank says that this combination has been looked at in non–small cell lung cancer as neoadjuvant therapy, but OpACIN was the first trial evaluating neoadjuvant treatment in patients with melanoma.

Now the investigators have the 3-year update of the findings. According to Blank, they saw was that patients who relapsed in the neoadjuvant setting that have not gone on to expanded studies made up 2 out of 7 patients.

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Nivolumab Plus Ipilimumab Extends TFS Over Nivolumab Alone in Advanced Melanoma https://melanomaresearchvic.com.au/nivolumab-plus-ipilimumab-extends-tfs-over-nivolumab-alone-in-advanced-melanoma Wed, 24 Jun 2020 06:01:45 +0000 https://melanomaresearchvic.com.au/?p=15207 With extended follow-up, patients with advanced melanoma given nivolumab plus ipilimumab were shown to have a treatment-free survival (TFS) twice as long as those given nivolumab monotherapy, according to data presented at the virtual 2020 ASCO Annual Meeting.

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Source: Oncology Learning Network, 2020

With extended follow-up, patients with advanced melanoma given nivolumab plus ipilimumab were shown to have a treatment-free survival (TFS) twice as long as those given nivolumab monotherapy, according to data presented at the virtual 2020 ASCO Annual Meeting.

“We previously defined a novel outcome, TFS, to characterize the time between immune-checkpoint inhibitors (ICI) therapy cessation and subsequent therapy initiation/death,” explained Meredith M. Regan, ScD, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts, and co-investigators.

In 2019, Dr Regan et al reported on the TFS of ICI-treated patients with advanced melanoma in the 36 months after randomization in the phase 3 CheckMate-067 trial. At the virtual meeting, they presented TFS data for 937 patients in CheckMate-067 in the 60 months post-randomization.

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Long-Term Benefit of Dabrafenib Plus Trametinib in Melanoma Confirmed in 5-Year Follow-Up of COMBI-AD Study https://melanomaresearchvic.com.au/long-term-benefit-of-dabrafenib-plus-trametinib-in-melanoma-confirmed-in-5-year-follow-up-of-combi-ad-study Wed, 24 Jun 2020 05:44:35 +0000 https://melanomaresearchvic.com.au/?p=15205 The long-term benefit of adjuvant dabrafenib (Tafinlar) plus trametinib (Mekinist) as treatment of patients with resected, stage III BRAF V600E/K-mutant melanoma were validated by 5-year data from the phase 3 COMBI-AD study, according to a presentation from the 2020 American Soceity of Clinical Oncology (ASCO) Virtual Scientific Program.

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Source: Targeted Oncology, May 2020

The long-term benefit of adjuvant dabrafenib (Tafinlar) plus trametinib (Mekinist) as treatment of patients with resected, stage III BRAF V600E/K-mutant melanoma were validated by 5-year data from the phase 3 COMBI-AD study, according to a presentation from the 2020 American Soceity of Clinical Oncology (ASCO) Virtual Scientific Program.

The 4- and 5-year relapse-free survival (RFS) rates were 55% (95% CI, 50-60) and 52% (95% CI, 48-58) with the doublet therapy versus 38% (95% CI, 34-43) and 36% (95% CI, 32-41) with placebo.

“There is a longer than 50% relapse-free survival,” said lead study author Axel Hauschild, MD, during a presentation at the 2020 ASCO Virtual Scientific Program. “The relapse-free survival curves for both treatment arms appear to be reaching a plateau, which is a good sign if we are talking about cure.”

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Early Trials in Melanoma Show Better Response After 1 Year https://melanomaresearchvic.com.au/early-trials-in-melanoma-show-better-response-after-1-year Wed, 03 Jun 2020 08:12:29 +0000 https://melanomaresearchvic.com.au/?p=15120 Richard D. Carvajal, MD, the director of Experimental Therapeutics and director of Melanoma Service at the Columbia University Medical Center, discusses 2 therapies in clinical trials registering patients with melanoma.

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Source: Targeted Oncology, May 2020

Richard D. Carvajal, MD, the director of Experimental Therapeutics and director of Melanoma Service at the Columbia University Medical Center, discusses 2 therapies in clinical trials registering patients with melanoma.

The first drug Carvajal talks about is called IDE196, and the other is called IMCgp100 or tebentafusp. IDE196 is a PKC inhibitor previously named LXS196, and it targets both a conventional and novel forms of PKC. In a previous clinical trial, a cohort of about 30 patients receiving this treatment on a twice daily schedule, the response rate was fairly modest; about a quarter of the patients were doing well after a year or more. He says this is fairly remarkable for this setting. IDE196 is now under evaluation in another clinical trial which will be trying to replicate or exceed these findings (NCT03947385).

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Adjuvant nivolumab plus ipilimumab or nivolumab monotherapy vs placebo in patients with resected stage IV melanoma with no evidence of disease (IMMUNED): A randomised, double-blind, placebo-controlled, phase 2 trial https://melanomaresearchvic.com.au/adjuvant-nivolumab-plus-ipilimumab-or-nivolumab-monotherapy-vs-placebo-in-patients-with-resected-stage-iv-melanoma-with-no-evidence-of-disease-immuned-a-randomised-double-blind-placebo-controlled Mon, 01 Jun 2020 09:11:19 +0000 https://melanomaresearchvic.com.au/?p=15098 Researchers conducted this randomised, double-blind, placebo-controlled, phase 2 trial to test the safety and effectiveness of adjuvant nivolumab plus ipilimumab or nivolumab monotherapy vs a placebo in patients with stage IV melanoma with no evidence of disease.

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Source: MDLinx, May 2020

Researchers conducted this randomised, double-blind, placebo-controlled, phase 2 trial to test the safety and effectiveness of adjuvant nivolumab plus ipilimumab or nivolumab monotherapy vs a placebo in patients with stage IV melanoma with no evidence of disease. This trial was conducted in 20 German academic medical centres. Eligible patients (aged 18 to 80 years) with stage IV melanoma with no evidence of disease after surgery or radiotherapy were randomly assigned (1:1:1), using a central, interactive, online system, to the nivolumab plus ipilimumab group (1 mg/kg of intravenous nivolumab every 3 weeks plus 3 mg/kg of intravenous ipilimumab every 3 weeks for four doses, followed by 3 mg/kg of nivolumab every 2 weeks), nivolumab monotherapy group (3 mg/kg of intravenous nivolumab every 2 weeks plus ipilimumab-matching placebo during weeks 1–12), or double-matching placebo group.

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Idera’s tilsotolimod shows positive effect in mid-stage melanoma study https://melanomaresearchvic.com.au/ideras-tilsotolimod-shows-positive-effect-in-mid-stage-melanoma-study Thu, 14 May 2020 10:23:18 +0000 https://melanomaresearchvic.com.au/?p=14987 Idera Pharmaceuticals (IDRA -2.4%) announces final results from a Phase 1/2 clinical trial, ILLUMINATE-204, evaluating Toll-like receptor 9 (TLR9) agonist tilsotolimod, combined with Bristol-Myers Squibb’s (BMY -1.4%) Yervoy (ipilimumab), in metastatic melanoma patients.

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Source: Seeking Alpha, April 2020
  • Idera Pharmaceuticals (IDRA -2.4%) announces final results from a Phase 1/2 clinical trial, ILLUMINATE-204, evaluating Toll-like receptor 9 (TLR9) agonist tilsotolimod, combined with Bristol-Myers Squibb’s (BMY -1.4%) Yervoy (ipilimumab), in metastatic melanoma patients.
  • In 49 evaluable subjects, the overall response rate was 22.4% (n=11/49), including two complete responders. 24 participants showed stable cancer implying a disease control rate of 71.4% (n=35/49).
  • Median overall survival (OS) was 21.0 months.
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On-off dosing of cancer drugs does not help melanoma patients https://melanomaresearchvic.com.au/on-off-dosing-of-cancer-drugs-does-not-help-melanoma-patients Tue, 12 May 2020 10:00:14 +0000 https://melanomaresearchvic.com.au/?p=14958 Drugs that home in on and block cell growth signals can dramatically shrink tumors, but all too often the cancer comes back. An attention-grabbing mouse study 7 years ago suggested these targeted drugs would work better at shrinking melanoma tumors if cancer patients got a break from their medicine every few weeks.

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Source: AAAS Science, April 2020

Drugs that home in on and block cell growth signals can dramatically shrink tumors, but all too often the cancer comes back. An attention-grabbing mouse study 7 years ago suggested these targeted drugs would work better at shrinking melanoma tumors if cancer patients got a break from their medicine every few weeks.

The first large trial to test this idea, however, has found that melanoma tumors grew back faster when patients were on such an “intermittent” dosing schedule. The study participants also lived no longer overall than those receiving the typical schedule of the drugs.

The disappointing results, to be presented today at part one of a virtual version of the American Association for Cancer Research’s annual meeting, throw cold water on a novel strategy for countering cancer drug resistance that is being tested in a number of clinical trials. “There were a lot of reasons to think this could work. … It seemed like a very powerful idea,” says oncologist Alain Algazi of the University of California (UC), San Francisco, who led the melanoma trial.

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Alternative pembrolizumab dosing schedule safe, effective in metastatic melanoma https://melanomaresearchvic.com.au/alternative-pembrolizumab-dosing-schedule-safe-effective-in-metastatic-melanoma Fri, 08 May 2020 09:25:01 +0000 https://melanomaresearchvic.com.au/?p=14939 Source: Healio, April 2020 An alternative pembrolizumab dosing regimen of 400 mg every 6 weeks appeared safe and effective for patients with metastatic melanoma, according to first clinical outcomes data from KEYNOTE-555 cohort B presented at the virtual American Association for Cancer Research Annual Meeting. “Pembrolizumab [Keytruda, Merck] is approved globally in multiple cancer indications […]

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Source: Healio, April 2020

An alternative pembrolizumab dosing regimen of 400 mg every 6 weeks appeared safe and effective for patients with metastatic melanoma, according to first clinical outcomes data from KEYNOTE-555 cohort B presented at the virtual American Association for Cancer Research Annual Meeting.

“Pembrolizumab [Keytruda, Merck] is approved globally in multiple cancer indications at a dose of 200 mg or 2 mg/kg every 3 weeks,” Mallika Lala, PhD, associate principal scientist at Merck & Co., said during a presentation. “An alternative dosing regimen of 400 mg every 6 weeks is proposed as an additional option to the currently approved dose, which provides convenience and flexibility to patients and providers — the need for which is particularly exemplified by the current COVID-19 pandemic. We selected this alternative dose based upon pharmacokinetic and exposure-response modeling and simulation data that formed the basis of its approval in markets including the European Union, Australia and New Zealand.”

The open-label KEYNOTE-555 cohort B study was designed to evaluate the alternative dosing schedule among 100 patients (mean age, 64 years; 59.1% men; mean body weight, 85 kg) with metastatic melanoma. Investigators sought to validate model-based assessments, as well as determine efficacy and safety of the 6-week regimen compared with historical data.

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