Clinical trial · Interventional
Universal Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)-Producing and CD40L Expressing Bystander Cell Line for Tumor Vaccine in Melanoma
A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Malignant 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)
The purpose of this study is to find out what effects (good and/or bad) this new cancer vaccine has on the patient and their cancer, whether it is safe and whether it can help get rid of their cancer (malignant melanoma). We want to check how the patient's immune system reacts, both before and after the vaccine treatment.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bystander-Based Autologous Tumor Cell Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vaccine Therapy
- description
- Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.
- interventionNames
- Biological: Bystander-Based Autologous Tumor Cell Vaccine
Primary outcomes (1)
- measure
- Number of Participants With Partial Response
- timeFrame
- Average of 14 months
- description
- Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Secondary outcomes (4)
- measure
- Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed stage IIIC or stage IV melanoma * Measurable disease * Age 18 or older * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * No radiation therapy within 2 weeks prior to first vaccine administration * No chemotherapy within 4 weeks prior to first vaccine administration * No steroid therapy within 4 weeks prior to first vaccine administration * No surgery within 10 days prior to first vaccine administration * Patient's written informed consent * Patient's ability to comply with the visit schedule and assessments required by the protocol * Adequate organ function (measured within a week of beginning treatment): * White blood count (WBC) \> 3,000/mm\^3 and absolute neutrophil count (ANC) \>1500/mm\^3 * Platelets \> 100,000/mm\^3 * Hematocrit \> 25% and Hgb \> 8 g/dL * Bilirubin \< 2.0 mg/dL * Creatinine \< 2.0 mg/dL, or creatinine clearance \> 60 mL/min Exclusion Criteria: * Symptomatic or untreated brain metastasis * Any serious ongoing infection * Current corticosteroid or other immunosuppressive therapy * Any other pre-existing immunodeficiency condition (including known HIV infection) * Pregnant or lactating women -- Patients in reproductive age must agree to use contraceptive methods for the duration of the study (\*A pregnancy test will be obtained before treatment) * ECOG performance status of 2, 3, or 4 * Any second active primary cancer
References
Publications (0)
Data not yet available