Can two immune boosters beat advanced melanoma?
NCT ID NCT01024231
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This early-phase trial is testing whether combining two immunotherapy drugs, nivolumab and ipilimumab, can safely treat advanced melanoma that cannot be removed by surgery. The study includes adults with stage III or IV melanoma and focuses on the safety and tolerability of the drug combination, given either at the same time or in sequence. Researchers will also look at how well the tumors respond to treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab (BMS-936558) combined with ipilimumab
- What this could lead to
- If this combination proves safe and effective, it could offer a new treatment option for advanced melanoma, potentially improving response rates and survival.
- What could go wrong
- This is an early-phase trial, so the combination may not work as hoped or could cause significant side effects. The results will need confirmation in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
127 people
The number who actually took part.
- Started
-
Dec 2009
- Finished
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Apr 2019
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histologic diagnosis of malignant melanoma (MEL) * Measurable unresectable Stage III or IV MEL * ECOG performance status score of 0 or 1 * Life expectancy ≥4 months * For those enrolled in amendment 5 and later, tumor tissue (archival or recent acquisition) must be available * For Cohorts 1-5, subjects may have been treated with up to 3 prior systemic standard treatments for metastatic melanoma not including any post-incisional adjuvant therapy. Subjects may be treatment naïve. All metastatic melanoma regardless of primary site of disease will be allowed * For Cohorts 6-7, subjects may have been treated with up to 3 prior systemic standard treatments for metastatic melanoma; this does not include any post-incisional adjuvant therapy. Specifically, subjects must have received ≥3 doses of Ipilimumab therapy and the last dose having been administered within 4-12 weeks of initiation of study treatment Exclusion Criteria: * History of severe hypersensitivity reactions to other mAbs * Prior malignancy active within the previous 2 years except for localized cancers that are considered to have been cured and in the opinion of the investigator present a low risk for recurrence * Active autoimmune disease or a history of known or suspected autoimmune disease * History of recently active diverticulitis or symptomatic peptic ulcer disease and history of adrenal insufficiency * Regular narcotic analgesia * Active, untreated central nervous system metastasis * For subjects enrolled in Cohorts 1-5, prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody * For subjects enrolled in Cohorts 6-7, prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CD137 antibodies * Any non-oncology vaccine therapy used for prevention of infectious disease * Concomitant therapy with any other anti-cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs * Positive tests for human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B, hepatitis C * Subjects weighing ≥125 kg are excluded from Cohort 5 * Subjects in Cohorts 6 and 7 must have received Ipilimumab monotherapy immediately prior to study entry, but must not have received that Ipilimumab as part of a clinical trial * Subjects with ocular melanoma are excluded from Cohort 8
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hillman Cancer Research Pavilion
Pittsburgh, Pennsylvania, 15232, United States
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Medstar Georgetown-Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007, United States
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Memorial Sloan Kettering Nassau
New York, New York, 11065, United States
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Yale University School Of Medicine
New Haven, Connecticut, 06520, United States
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