Melanoma studies

Ongoing clinical studies:

  1. ABC - X 

A phase II, open label, randomised trial of Ipilimumab and Nivolumab with concurrent intracranial stereotactic radiotherapy versus Ipilimumab and Nivolumab alone in patients with melanoma brain metastases.

  1. GO 42273

A phase 1b, multicenter study to evaluate the safety, pharmacokinetics and activity of belvarafenib alone and in combination with cobimetinib or cobimetinib and atezolizumab in patients with NRAS mutated advanced melanoma who have received anti-PD-1/ PD-L1 therapy. 

  1. RELATIVITY 098

A phase 3, randomized, double-blind study of adjuvant immunotherapy with Relatlimab and Nivolumab, fixed-dose combination versus Nivolumab monotherapy after complete resection of stage III-IV melanoma.

  1. UV1-202 INITIUM

A study investigating the efficacy and safety of UV1-vaccine in combination with Nivolumab and Ipilimumab for the treatment of patients with metastatic melanoma.

  1. Chemobrain

A PET / CT study of the brain before systemic treatment and 1 year later compared to a control group that does not receive systemic treatment – in melanoma patients without known brain disease.

  1. MITRIC

A phase 2a, basket study with the transfer of intestinal flora to among others melanoma patients who have no effect of immunotherapy. One will study the feasibility, safety and effect of fecal microbiotic transplantation (FMT) in cancer patients. Patients who respond to immunotherapy donate feces to the study. FMT will be combined with immunotherapy to investigate whether altered gut flora can trigger a treatment response.

  1. TREATMENT

A study testing the degree of response and pseudoprogression after stereotactic radiotherapy of brain metastases in patients with melanoma or lung cancer. This is a radiological study where advanced perfusion techniques are used in MRI. MRI of the brain is done before SRT / SRS and then regularly for up to 3 years. The inclusion has ended but data collection continues until January 2023.

Planned clinical studies

  1. Starboard (C4221016)

A phase 3, randomized, double-blind study of encorafenib and binimetinib plus Pembrolizumab versus placebo  plus Pembrolizumab in previously untreated participants with BRAF V600E/K mutation-positive metastastic or unresectable locally advanced melanoma.

Readt for start-up Dec. -22 / Jan -23

  1. Columbus – AD

Adjuvant encorafenib & binimetinib vs. placebo in fully resected stage IIB / C BRAF V600E/K mutated melanoma: a randomized triple-blind phase III study in collaboration with the EORTC Melanoma Group.

Research studies

Risk predication and treatment stratification for metastatic melanoma

Melanoma patients with lymph node (LN) metastasis get adjuvant treatment after surgery. This will reduce the risk for recurrence for half of the patients, while a significant number will experience side effects. The tumor immune microenvironment determines whether the tumor is at risk to progress and how it responds to treatment.  We aim to analyse tumor immune interactions in LN metastases to identify markers that can tell who are cured by surgery (without need of additional treatment) and who will benefit from adjuvant treatment. The goal is to personalize the management of metastatic melanoma – treat the right patients and avoid treatment of patient without any benefit.

 
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