Clinical trial · Observational
Selection Pressure and Evolution Induced by Immune Checkpoint Inhibitors and Other Immunologic Therapies
NCT02724488CI-TRIAL-00117892SPECIALcompletedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Two part prospective study to: 1. investigate the feasibility of performing ultra-deep sequencing of plasma derived circulating tumor DNA (ctDNA) in individual patients with advanced solid tumors who are currently being treated with immune checkpoint inhibitors (ICIs) and 2. obtain fresh tumor biopsies and serial blood samples to investigate the clonal evolution of tumors under the selection pressure of ICIs.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Part 1
- description
- Patients with a histological or cytological diagnosis of advanced solid tumors who are currently on immune checkpoint inhibitors will have archival tumor specimens requested and used for whole exome sequencing (WES) of tumor DNA. 3 tubes of blood at a single time point will be collected for ctDNA analysis and germ line DNA analysis (to study normal variants) using next generation sequencing.
- label
- Part 2
- description
- Patients with a histological or cytological diagnosis of advanced solid tumors who are candidates for a phase I, II, or III clinical trial testing immune checkpoint inhibitors (ICIs) or planning to have treatment with ICIs or other immunological therapy as standard of care will have image-guided fresh tumor core needle biopsy at a maximum of 3 time points: 1) prior to commencement of immune checkpoint inhibitors, 2) when disease response to therapy is confirmed using radiology RECIST 1.1 criteria and/or immune related response criteria, and 3) when radiological disease progression is confirmed by using RECIST 1.1. Blood samples for ctDNA analysis will be collected at the commencement of immunotherapy and every 6-12 weeks thereafter until radiological disease progression is confirmed.
Primary outcomes (2)
- measure
- Part 1: The detection of new mutations from circulating tumor DNA (ctDNA) analyses or change in the frequency of mutations found in archival tumor Whole Exome Sequencing (WES) analyses.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
PART 1: Inclusion Criteria: 1. Age \> 18 years. 2. Histological or cytological proof of metastatic solid tumors. 3. Currently receiving immune checkpoint inhibitors or other immunologic therapies of interest (to be determined by study principal investigators). 4. Willingness and ability of patient to provide signed voluntary informed consent. Exclusion Criteria: 1. Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment. 2. Any contraindication to undergoing a venepuncture. PART 2: Inclusion Criteria: 1. Age \> 18 years. 2. Histological or cytological proof of metastatic solid tumors. 3. At least one biopsiable lesion deemed medically accessible and safe to biopsy. 4. Candidate for one or more phase I or II or III clinical trials with immune checkpoint inhibitors at the time of study enrolment. Patients receiving approved immune checkpoint inhibitors or via special access are also eligible. Patients receiving other immunologic therapies of interest may be allowed (to be determined by study principal investigators). 5. Fulfills local institution's laboratory parameters for tumor biopsy. 6. Willingness and ability of patient to provide signed voluntary informed consent. Exclusion Criteria: 1. Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment. 2. Any contraindication to undergoing a biopsy procedure. 3. Any contraindication to undergoing a venepuncture.
References
Publications (0)
Data not yet available
No reference posted for this study.