Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

NADINA : Multicenter Phase 3 Trial Comparing Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma - NADINA

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Surgical<br/>TrialTypeSurgical
Trial

ThreePhase Three

16+Age Over 16

Skin<br/>CancersCancer LocationSkin
Cancers

Surgical,Systemic therapy,Treatment | SkinMelanoma (Skin)

Trial Overview Read MoreRead more

This phase III study is evaluating the effectiveness of immunotherapy (ipilimumab and nivolumab) followed by the surgical removal of lymph nodes, compared to the standard upfront removal of lymph nodes followed by immunotherapy (nivolumab alone), in people with stage III melanoma.
 

This trial is treating patients with stage III melanoma.

This is a surgical and systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

Multicenter Phase 3 Trial Comparing Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma - NADINA

Commercial Sponsor

Bristol-Myers Squibb (BMS)

Other Non-Commercial Sponsor

Netherlands Cancer Institute

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or Active Comparator Arm. In the Experimental Arm, participants will receive 2 cycles of neoadjuvant ipilimumab (80mg) and nivolumab (240mg) every 3 weeks, followed by a total lymph node dissection (TLND), and if applicable, surgical removal of in-transit metastases. Participants with a pathologic partial or non-response will also then receive adjuvant nivolumab (480mg) every 4 weeks for 46 weeks. In the case of BRAF V600E/K mutation-positivity, participants with a pathologic partial or non-response will be treated with adjuvant dabrafenib plus trametinib for 46 weeks. In the Active Comparator Arm, participants will receive a standard upfront TLND, and if applicable, surgical removal of in-transit metastases, followed by 12 cycles of adjuvant nivolumab (480mg) every 4 weeks. All study participants will be treated until melanoma progression to irresectable stage III or stage IV disease, disease recurrence, unacceptable toxicity, participant withdrawal of consent or until the end of study treatment.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Medical Oncology
Prahran
Mr James Daphne
J.Daphne@alfred.org.au
03 9076 0566

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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