Clinical trial · Interventional
QUILT-2.008: Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma
Phase Ib/II Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma
NCT01029873CI-TRIAL-00024463terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-801 combined with cisplatin. The purpose of this study is to evaluate the safety, determine the Maximum-Tolerated Dose (MTD), and characterize the pharmacokinetic profile of ALT-801 given with cisplatin in patients who are chemotherapy naïve and have metastatic melanoma that is considered surgically incurable. The anti-tumor responses of ALT-801 with cisplatin will also be assessed in this trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALT-801 | Biological | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- ALT-801 - 0.04 mg/kg + cisplatin
- description
- Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses. Participants received cisplatin 70 mg/m\^2 on cycle 1 day 1 only.
- interventionNames
- Drug: Cisplatin
- Biological: ALT-801
- type
- EXPERIMENTAL
- label
- ALT-801 - 0.06 mg/kg + cisplatin
- description
- Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses. Participants received cisplatin 70 mg/m\^2 on cycle 1 day 1 only.
- interventionNames
- Drug: Cisplatin
- Biological: ALT-801
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.