Experimental melanoma combo trial shutters after just one patient
NCT ID NCT04093323
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tested a mix of a personalized dendritic cell vaccine and three immune-boosting drugs in people with advanced melanoma that no longer responded to PD-1/PD-L1 checkpoint inhibitors. The goal was to see if the combination could shrink tumors or slow their growth. However, the study was terminated after enrolling only one participant, so no meaningful results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dendritic cell vaccine (aDC1) plus interferon alfa-2b, rintatolimod, and celecoxib
- What this could lead to
- If it worked, this combination might help melanoma patients whose tumors no longer respond to standard immunotherapy.
- What could go wrong
- The trial was terminated after enrolling only 1 person, so we have almost no data. It is very early and uncertain whether this approach is safe or effective.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
1 person
The number who actually took part.
- Started
-
Nov 2024
- Finished
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Jun 2025
- 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
-
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 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: * Participant must be HLA-A2+. Retesting is not required for patients who have previous documented positivity * Have IO-refractory melanoma with primary PD-1/PD-L1resistance. Note: Any lines of prior therapies are allowed, but the last line needs to include an anti PD-1 or anti PD-L1 agent. The prior treatments may include any standard and/or experimental therapies * Have \>= 1 tumor site amenable to core needle biopsy that is not the site of disease used to measure antitumor response * Have measurable disease based on RECIST 1.1 criteria present * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Platelets \>= 75,000/microliter * Hemoglobin \>= 9 g/deciliter * Absolute neutrophil count (ANC) \>= 1500/microliter * Creatinine \< 1.5 x institutional upper limit of normal (ULN) OR creatinine clearance \>= 50 mL/min by Cockcroft-Gault formula for subjects with creatinine levels \>= 1.5 x ULN * Total bilirubin not greater than 1.5 x institutional ULN, except for patients with known Gilbert's Syndrome, who are eligible to no more than 2 x institutional ULN * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) no greater than 3 x institutional ULN OR, no greater than 5 x ULN for subjects with liver metastases * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure * Candidate for continuation/resumption of anti-PD-1/PD-L1 blockade (in parallel to DC vaccine and CKM) Exclusion Criteria: * Is currently being treated with systemic immunosuppressive agents, including steroids: Subjects will be ineligible until 3 weeks after removal from immunosuppressive treatments, except when they are administered as replacement therapy for endocrine dysfunction (and receive no more than 10 mg prednisone or equivalent: inhaled steroids are allowed) * Has had prior anti-cancer therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., no more than grade 1 or at baseline) from adverse events due to a previously administered agent, except for neuropathy (no more than grade 2) or alopecia or vitiligo (any grade) * Has a known additional malignancy that is progressing or requires active treatment * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Treated brain metastases are allowed, if stable for more than 4 weeks (and receive no more than 10 mg prednisone or equivalent: inhaled steroids are allowed). * Has a history of cardiac event(s) (acute coronary syndrome, myocardial infarction, or ischemia (within 3 months of signing consent) or, subject has a New York Heart Association classification of III or IV * Has an active infection requiring systemic therapy * Has known active hepatitis B or hepatitis C infection * Has known immunosuppressive disease (e.g. human immunodeficiency virus \[HIV\], acquired immunodeficiency syndrome \[AIDS\] or other immune depressing disease). Testing is not mandatory * Has known serious hypersensitivity reactions to pegylated (peg)-interferon alpha-2b or interferon alpha-2b * Prior allergic reaction or hypersensitivity to sulfonamides, celecoxib, or nonsteroidal anti-inflammatory drugs (NSAIDs) * Has received a blood transfusion in the two weeks prior to leukapheresis * Women of child bearing potential who are pregnant or nursing * Unwilling or unable to follow protocol requirements * Any condition which in the Investigator's opinion deems the participant an unsuitable candidate or unacceptable risk to receive study drug regimen * Patients who showed initial response to PD-1/PD-L1 blockade and developed secondary resistance
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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
-
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Supercharged immune cells take on hard-to-treat melanoma in early trial