Clinical trial · Interventional
Intradermal Injection of Anti-CTLA-4 in Patients With Stage I/II Melanoma
Releasing the Brakes on CD8+ T Cells in the Melanoma Sentinel Lymph Node by Pre-operative Local Administration of Low-dose Anti-CTLA-4 (Tremelimumab)
- 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)
This study evaluates the clinical safety and tolerability, and the immunological effects of local intradermal injection of tremelimumab in patients with clinical stage I/II melanoma patients undergoing a sentinel node biopsy (SNB). Patients will be treated by local intradermal injections around the excision site of the primary tumor with escalating doses of 2, 5, 10 or 20 mg tremelimumab.
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 |
|---|---|---|---|
| Cutaneous Melanoma | Cutaneous Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tremelimumab | Drug | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tremelimumab
- description
- Intradermal injection of tremelimumab at the primary melanoma excision site, 7 days prior to sentinel node biopsy (SNB), with escalating doses of 2, 5, 10 or 20 mg tremelimumab (3 patients per dose level with an expansion at the optimal dose level with an additional 5 patients).
- interventionNames
- Drug: Tremelimumab
Primary outcomes (3)
- measure
- Number of participants with adverse events as assessed by CTCAE V3.0
- timeFrame
- From the time of injection until 28 days after injection of tremelimumab
- description
- The descriptions and grading scales of CTCAE V 3.0 will be utilized for all toxicity reporting
- measure
- Change in frequency of immune cell populations (compared to baseline) assessed by immune monitoring through flow cytometry,
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Clinical stage I/II melanoma patients, planned to undergo a sentinel lymph node biopsy (SNB) * ECOG performance status 0 or 1 * White blood count (WBC) ≥ 3 x10\^9/L * Platelet count ≥ 100 x10\^9/L * Hemoglobin ≥ 6.5 mmol/L * Serum creatinine ≤ 2.5 x ULN * Total serum bilirubin, AST, ALT and LDH ≤ 2x ULN Exclusion Criteria: * Non-oncology vaccine therapy used for prevention of infectious diseases (up-to) 4 weeks prior and/r 8 weeks after any dose of tremelimumab * Prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist * Uncontrolled infectious disease including negative testing for HIV, HBV, HCV * Autoimmune disease
References
Publications (1)
- DERIVEDvan Pul KM, Notohardjo JCL, Fransen MF, Koster BD, Stam AGM, Chondronasiou D, Lougheed SM, Bakker J, Kandiah V, van den Tol MP, Jooss K, Vuylsteke RJCLM, van den Eertwegh AJM, de Gruijl TD. Local delivery of low-dose anti-CTLA-4 to the melanoma lymphatic basin leads to systemic Treg reduction and effector T cell activation. Sci Immunol. 2022 Jul 15;7(73):eabn8097. doi: 10.1126/sciimmunol.abn8097. Epub 2022 Jul 15. PMID 35857579