New immunotherapy cocktail aims to beat melanoma relapse
NCT ID NCT02656706
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests a combination of two immunotherapy drugs, nivolumab and low-dose ipilimumab, given after surgery to patients with stage III or resected stage IV melanoma. The goal is to see if this regimen is safer and more effective than standard high-dose interferon, which is highly toxic. The study enrolled 22 participants and will track side effects and survival outcomes over six months of 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 and ipilimumab (immunotherapy drugs)
- What this could lead to
- If successful, this combination could offer a more effective and less toxic adjuvant treatment for high-risk melanoma, potentially increasing the chance of long-term remission.
- What could go wrong
- This is a small phase II trial with only 22 participants, so results may not apply broadly. The drugs can cause serious immune-related side effects, and it is unclear if the combination will be better than existing options.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
22 people
The number who actually took part.
- Started
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Jul 2016
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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.
Inclusion Criteria: * Histologically or cytologically proven melanoma. The primary site of melanoma may be cutaneous on other body site such as ocular or anorectal. Documentation required to be sent to BrUOG. * Completely resected stage III (lymph node positive) or resected stage IV disease. Patients with stage T4BN0 are also eligible. It is required that patients with stage IIIA disease have \> 1mm nodal involvement via pathology assessment of the resected node. All patients must be disease free to be eligible. * No prior treatment for melanoma other than surgical resection or radiation. At least 4 weeks since prior surgery and 3 weeks since prior radiation to registration date. * Age \>/= 18 years * ECOG performance status 0-1 * Patients must have organ and marrow function as defined below within 14 days of study entry: Hematologic Absolute neutrophil count (ANC) \>/= 1.5 X 109/L; Hemoglobin \>/= 9.5 g/dL; Platelets \>/= 100 X 109/L; Total Bilirubin ≤ 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilbert's syndrome. Send information to BrUOG if patient has known Gilbert's syndrome AST and ALT \</= 2.5 X ULN Albumin \>/= 2.5 g/dL Renal Creatinine OR Calculated creatinine clearance : Creatinine \</= 1.5 mg/dl or creatinine clearance \> 50ml/min * No clinically significant coagulation disorder as defined by the treating MD. Therapeutic use of anticoagulants is permissible. Add to concomitant medication log if applicable. * Not pregnant and not nursing. Women of child bearing potential must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to Day 1 of treatment. Post-menopausal women (surgical menopause or lack of menses \>12 months) do not need to have a pregnancy test, please document status. * Confirmation of informed consent. * Men and women of childbearing potential enrolled in this study must agree to use adequate barrier birth control measures during the course of the study and up to 2 months after end of treatment. Exclusion Criteria: * Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug * Brain metastases, whether resected or not, and any known leptomeningeal disease or known bone metastases. * Pregnant or breastfeeding female * Unwillingness or inability to follow the procedures required in the protocol, to document * Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results. * Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast. Documentation required to be sent to BrUOG * Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, controlled type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \>10mg daily of prednisone equivalents are permitted in the absence of active autoimmune disease. * Prior treatment with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody * Any positive test result for hepatitis B or C virus indicating acute or chronic infection * Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome * History of severe hypersensitivity reaction to any monoclonal antibody. * Patients with unstable angina (anginal symptoms at rest) or new-onset angina (began within the last 3 months) or myocardial infarction within the past 6 months. * History of autologous transplant or organ allograft even if not taking immunosuppressive medications
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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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Rhode Island Hospital and The Miriam Hospital
Providence, Rhode Island, 02903/02906, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New antibody GNR-051 tested for safety in Hard-to-Treat cancers
- Blood test could spot Melanoma's BRAF mutation
- Can a CXCR1/2 blocker boost radiation against cancer that spreads to the brain lining?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can tumor DNA and immune cells reveal why some cancers resist immunotherapy?
- Can a Two-Drug immune combo shrink melanoma tumors?