InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.Learn why

Optimise reading forHealth ProfessionalsPatients

Closed (no longer recruiting)Last updated: 30 January 2024

This Phase III trial is evaluating immunotherapy (with Nivolumab) alone and in combination with an oral drug (BMS-986205) for the treatment of previously untreated, advanced MelanomaA Phase 3, Randomized, Double-blind Study of BMS-986205 Combined With Nivolumab Versus Nivolumab in Participants With Metastatic or Unresectable Melanoma That is Previously Untreated

Clinical summary

Summary

The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated.

Conditions

This trial is treating patients with Melanoma.

Cancer

Skin Cancers Skin

Age

People12+

Phase

III

More information

Trial Identifiers

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

Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined With Nivolumab Versus Nivolumab in Participants With Metastatic or Unresectable Melanoma That is Previously Untreated

Eligibility

Inclusion

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

  • 12 years and older unless not permitted by local regulations; in that case 18 years old and older
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1
  • Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) Staging Manual (8th edition)
  • Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma)
  • Measurable disease per RECIST v1.1

Exclusion

  • Active brain metastases or leptomeningeal metastases
  • Uveal or ocular melanoma
  • Participants with active, known, or suspected autoimmune disease
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured

Other protocol defined inclusion/exclusion criteria could apply

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

Closed hospitals

Completed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

Speak with someone who has cancer clinical trial experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

CloseReport inaccuracy

Thank you for helping us to increase accuracy of the trial. Our team will validate the information and update the information as soon as possible.

Submitting ... Please wait

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.