Can an immune booster make chemo hit melanoma harder?
NCT ID NCT01029873
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Researchers are testing an experimental immunotherapy called ALT-801 alongside the chemotherapy drug cisplatin in people with metastatic melanoma that cannot be cured with surgery. The trial enrolls about 22 participants who have not received prior chemotherapy for their melanoma. The main goals are to find the highest safe dose of ALT-801, check for side effects, and see whether tumors shrink in response to the combination.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- An experimental immunotherapy called ALT-801, given with the chemotherapy drug cisplatin
- What this could lead to
- If it works, this combination could offer a new way to shrink tumors in people whose melanoma cannot be removed by surgery.
- What could go wrong
- This is a small, early-stage trial, so most experimental cancer treatments fail or help only a few people. Combining an immune therapy with chemotherapy can also cause serious side effects.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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22 people
The number who actually took part.
- Started
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Feb 2010
- Finished
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Sep 2013
- 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
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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.
ENTRY CRITERIA: DISEASE CHARACTERISTICS: * Locally advanced or metastatic melanoma * Measurable * Histologically or cytologically confirmed * Surgically incurable * HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT THERAPY: * If prior Proleukin treatment, must have had clinical benefit * No prior systemic cytotoxic chemotherapy for melanoma * No concurrent radiotherapy, chemotherapy, or other immunotherapy * More than 4 weeks since prior major radiotherapy * More than 8 weeks since prior CTLA-4 antagonist immunotherapy * Not receiving other investigational agents PATIENT CHARACTERISTICS: Life expectancy * \> 3 months Performance status * ECOG 0 or 1 Bone marrow reserve * Absolute neutrophil count (AGC/ANC) ≥ 1,500/uL * Platelets ≥100,000/uL * Hemoglobin ≥ 10g/dL Renal function * Serum creatinine ≤ 1.5 mg/dL Hepatic function * Total bilirubin ≤ 1.5 X ULN * AST ≤ 2.5 X ULN * Alkaline phosphatase ≤ 2.5 X ULN * PT INR ≤ 1.5 X ULN * aPTT ≤ 1.5 X ULN Cardiovascular * May be safely tapered off anti-hypertensives if currently on anti-hypertensives * New York Heart Association classification I or II * No congestive heart failure \<6 months * No unstable angina pectoris \<6 months * No myocardial infarction \<6 months * No history of ventricular arrhythmias * Normal cardiac stress test required if any of the following is present: * Age ≥ 50 * History of abnormal EKG * Symptoms of cardiac ischemia or arrhythmia Pulmonary * Normal pulmonary function test (FEV1 ≥ 70% of predicted value) if any of the following is present: * Prolonged history of cigarette smoking * Symptoms of respiratory dysfunction Other * No known autoimmune disease * No known HIV positive * No psychiatric illness/social situations that would limit study compliance * No history or evidence of CNS disease * No active systemic infection requiring parental antibiotic therapy * No systemic steroid therapy required * No prior organ allograft or allogeneic transplantation * Not receiving chronic medication for asthma * Not pregnant or nursing * Fertile patients must use effective contraception
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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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Carolinas Medical Center-Brumenthal Cancer Center
Charlotte, North Carolina, 28204, United States
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Emory University
Atlanta, Georgia, 30322, United States
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MD Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, 18015, United States
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The Angeles Clinic and Research Institute
Los Angeles, California, 90025, United States
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
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University of Washington, Seattle Cancer Care Center
Seattle, Washington, 98109, United States
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Other studies related to the condition(s) this trial covers.
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- Can a DNA vaccine teach the immune system to hunt melanoma?
- A quest to find biomarkers that match melanoma patients with the right immunotherapy
- Can a triple immunotherapy attack beat advanced melanoma?
- Can a flash of radiation tame melanoma skin lesions?