Trial purpose
Cancer treatment
Tumor type
Skin
Age
15 - 75
Clinical summary
Summary
This is a safety and efficacy study of different administration regimens of nivolumab plus Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.
Conditions
This trial is treating people with Melanoma
Eligibility
Inclusion
- Males and Females, ages 15 years ≥ of age (Except where local regulations and/or institutional policies do not allow for subjects < 18 years of age to participate)
- Subjects must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma that is unresectable or metastatic
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Subjects have not been treated by systemic anticancer therapy for unresectable or metastatic melanoma
Exclusion
- Subjects with active brain metastases or leptomeningeal metastases
- Subjects with ocular melanoma
- Subjects with active, known or suspected autoimmune disease
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 (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Bristol-Myers Squibb (BMS)
Scientific Title
Phase IIIb, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Previously Untreated Unresectable or Metastatic Melanoma
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