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Can two immune boosters beat advanced melanoma?

NCT ID NCT01024231

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

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

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

  • Hillman Cancer Research Pavilion

    Pittsburgh, Pennsylvania, 15232, United States

  • Medstar Georgetown-Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007, United States

  • Memorial Sloan Kettering Nassau

    New York, New York, 11065, United States

  • Yale University School Of Medicine

    New Haven, Connecticut, 06520, United States

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