Clinical trial · Interventional
Tissue Procurement Substudy for Participants in Study CP-MGA271-01
A Tissue Procurement and Examination Substudy of Study CP-MGA271-01 (NCT01391143)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to accrue as planned for optional biopsies
Summary
Brief summary (as posted)
The purpose of this study is to gain a better understanding about how the study drug MGA271 works. No test drug will be given in this study. Patients with easily accessible tumors at the screening visit for participation in Study CP-MGA271-01 will be asked to participate in this substudy. Patients will undergo two excisional biopsies, punch biopsies, or core needle biopsies.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MGA271 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MGA271
- description
- MGA271 (administered in main study CP-MGA271-01)
- interventionNames
- Biological: MGA271
Primary outcomes (1)
- measure
- Mechanism of Action
- timeFrame
- up to 50 days
- description
- Exploratory analyses from immunohistochemistry (IHC) and flow cytometry testing to determine the effect of MGA271 on tumor cells.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Qualified, by meeting all inclusion and exclusion criteria, for participation in Study CP-MGA271-01. * Must have provided informed consent to participate in Study CP-MGA271-01. * Must have accessible tumors (generally speaking, metastatic deposits involving skin, subcutaneous tissue, or peripheral lymph node whose excision, punch biopsy, or core needle biopsy would not require general anaesthesia or the invasion of a body cavity). * Willing to undergo two minor surgical procedures with no expectation of personal benefit * Have provided Informed Consent for this substudy as indicated by a signature on an approved consent document obtained from the patient or his/her legally authorized representative Exclusion Criteria: * Any medical condition that would contraindicate the use of local or locoregional anaesthesia, or conscious sedation for the intended minor surgical procedure. * Any medical condition (eg. skin disease or bleeding diathesis) that would hinder wound healing following a minor surgical procedure. * Dementia or altered mental status that would preclude understanding and rendering of informed consent.
References
Publications (0)
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