Clinical trial · Interventional
A-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation for Treatment of Stage IV Melanoma
Phase I/II Trial of A-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation for the Treatment of Stage IV Melanoma
NCT01888081CI-TRIAL-00024888terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Protocol replaced with combination therapy adding KEYTRUDA (pembrolizumab)
Summary
Brief summary (as posted)
The purpose of this trial is to study A-dmDT390-bisFv(UCHT1) in combination with ionizing irradiation for the treatment of stage IV melanoma, a disease that is essentially incurable with median overall survival periods that range from 8-16 months.
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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A-dmDT390-bisFv(UCHT1) (Resimmune®) | Drug | — | UNRESOLVED |
| Ionizing Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A-dmDT390-bisFv(UCHT1) with Ionizing Radiation
- description
- A-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation
- interventionNames
- Drug: A-dmDT390-bisFv(UCHT1) (Resimmune®)
- Radiation: Ionizing Radiation
Primary outcomes (1)
- measure
- Immune-related overall response rate (irORR)
- timeFrame
- For up to 1 year post treatment or until disease progression
- description
- Response will be assessed at 2 months, and at least every 3 months (±7 days) thereafter using for up to 1 year after the last treatment administration or until evidence of disease progression. Tumor measurements and therapeutic response will be determined using irRC (Immune Related Response Criteria). At a minimum, CT scans of the chest, abdomen, and pelvis will be performed at study entry, at 2 months, and, if a response or stable disease, at least every 3 months (±7 days) for up to 1 year after the last dose of study drug, and/or at any time there is clinical evidence of disease progression, to evaluate disease status.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * All patients must have histologically proven stage IV metastatic melanoma consisting of at least two lesions * Patients must have a performance status of \< 2 on Eastern Cooperative Oncology Group scale (see Appendix). * Patients must have bilirubin \< 1.5 mg/dL, transaminases \< 2.5 X ULN, albumin \> 3 gm/dL, creatinine \< 2.0 mg/dL, adequate pulmonary function by physical exam and pulse oximetry and adequate cardiac reserve (EF \> 50% normal). Patients must have a normal echocardiogram without any evidence of cardiac chamber hypertrophy, dilatation or hypokinesis. * Patients must give written informed consent prior to registration. * Females and males must be willing to use an approved form of birth control while on this study and for 2 weeks after completion. * Patients of ages 18-80 are eligible provided they have stage IV melanoma and are negative for BRAF or have failed BRAF inhibitor treatment or if they have failed or are intolerant to other established therapy known to provide clinical benefit for their condition or if they have been adequately consented and agreed to forgo FDA approved clinically meaningful therapy Exclusion Criteria: * Inability to give informed consent because of psychiatric problems, or complicated medical problems. * Serious concurrent medical problems, uncontrolled infections, or disseminated intravascular coagulopathy (DIC). * Preexisting cardiovascular disease, the only exception being well controlled essential hypertension with a sitting blood pressure of \<155 systolic and \<90 diastolic without any evidence of structural heart disease or one episode of myocardial infarction \> 8 months ago. A past history of the any of the following are exclusions: congestive heart failure, atrial fibrillation, pulmonary hypertension, anticoagulant drug therapy, thromboembolic events, cardiomyopathy or a myocardial infarction within the past 8 months. * Pregnant or nursing women will be excluded from study. * History of congestive heart failure. * History of cirrhosis of the liver
References
Publications (0)
Data not yet available
No reference posted for this study.