Clinical trial · Interventional
Cyclophosphamide and Fludarabine Followed by Cellular Adoptive Immunotherapy and Vaccine Therapy in Patients With Metastatic Melanoma
Phase I Study of In Vivo Expansion of Melan-A/MART-1 Antigen-Specific CD8 T Lymphocytes Following Transient Immunosuppression in Patients With Advanced Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, may be used to prepare the body for other treatments, such as cellular adoptive immunotherapy. Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines may help the body build an effective immune response to kill tumor cells. Giving cyclophosphamide together with fludarabine followed by biological therapy may be an effective treatment for metastatic melanoma. PURPOSE: This phase I trial is studying the side effects of giving cyclophosphamide together with fludarabine followed by cellular adoptive immunotherapy, and vaccine therapy in treating patients with metastatic melanoma.
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 (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adoptive immunotherapy | Biological | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| Melan-A VLP vaccine, IMP321 adjuvant | Biological | — | UNRESOLVED |
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lymphodepletion, vaccine, IMP321 adjuvant
- interventionNames
- Biological: Melan-A VLP vaccine, IMP321 adjuvant
- Biological: adoptive immunotherapy
- Biological: therapeutic autologous lymphocytes
- Drug: cyclophosphamide
- Drug: fludarabine phosphate
Primary outcomes (3)
- measure
- Phenotype, function, and T-cell receptor repertoire
- timeFrame
- Anti-tumor immune response evaluated at each vaccine and until the last administered vaccine
- measure
- Tumor response
- timeFrame
- Tumor response evaluated 4 weeks after last vaccine
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of metastatic melanoma * Progressive disease after receiving prior Melan-A peptide vaccine on an immunotherapy protocol of the Ludwig Institute AND achieved a detectable immune response (increase of specific CD8\^+ TET\^+ Melan-A) * Tumor must express MART-1/Melan-A antigen * HLA-A2 positive * Not eligible for other protocols due to progressive disease OR maximum number of vaccine injections with stable disease has been attained PATIENT CHARACTERISTICS: * Performance status 0-2 * Whole blood counts normal * Pulmonary status normal * Transaminases \< 1.5 times upper limit of normal (ULN) * Gamma-glutamyl-transferase \< 1.5 times ULN * Bilirubin normal * Creatinine clearance \> 70 mL/min * No major uncontrolled heart disease * No arterial hypertension PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior chemotherapy, biologic therapy, radiotherapy, and/or surgery allowed
References
Publications (1)
- DERIVEDRomano E, Michielin O, Voelter V, Laurent J, Bichat H, Stravodimou A, Romero P, Speiser DE, Triebel F, Leyvraz S, Harari A. MART-1 peptide vaccination plus IMP321 (LAG-3Ig fusion protein) in patients receiving autologous PBMCs after lymphodepletion: results of a Phase I trial. J Transl Med. 2014 Apr 12;12:97. doi: 10.1186/1479-5876-12-97. PMID 24726012