Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT02676869
Eligibility Criteria:
Main Inclusion Criteria
* Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma
* Currently receiving anti-PD-1 therapy with pembrolizumab and after 3 cycles achieved asymptomatic irPD (slowly progressive, not requiring urgent intervention, and stable performance status) or sub-optimal response (irSD, irPR) as demonstrated in imaging assessments performed within 6 weeks prior to study start
* Female or male 18 years of age or above
* ECOG performance status 0-1
* Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 10. Adequate Laboratory criteria
Main Exclusion Criteria
* More than four prior lines of therapies for advanced or metastatic disease.
* Prior PD-1/PDL-1 targeted therapy
* Currently receiving treatment with another investigational drug, or less than 4 weeks since ending treatment on another investigational drug
* Currently receiving systemic chemotherapy, targeted small molecule therapy, radiotherapy, or biological cancer therapy (other than pembrolizumab) or less than 4 weeks since completion of these therapies and first dose of study treatment
* History of irAEs from ipilimumab of CTCAE Grade 4 requiring steroid treatment
* Known cerebral or leptomeningeal metastases
* Serious intercurrent infection within 4 weeks prior to first dose of study treatment
* Active acute or chronic infection
* History or evidence of interstitial lung disease or active non-infectious pneumonitis
* Active auto-immune disease requiring immunosuppressive therapy
* HIV positivity, active hepatitis B or hepatitis C
* Continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02676869
Study Brief:
Protocol Section:
NCT02676869