Biomarkers for the Activity of Immune Checkpoint Inhibitor Therapy in Patients With Advanced Melanoma

Malignant Melanoma Clinical Trial

— ICIT  

Official title:

Biomarkers for the Activity of Immune Checkpoint Inhibitor Therapy in Patients With Advanced Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02673970
• Other study ID #: 2014-BN-001
• Status: Recruiting
• Start date: October 2014
• Est. completion date: December 2025

Study information

• Verified date: December 2020
• Source: Universitair Ziekenhuis Brussel
• Contact: Bart Neyns, MD; PhD
• Phone: 024746040
• Email: bart.neyns[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. Screen and recruitment: patients will be screened based on their prior history and intention to initiate treatment with an immune checkpoint inhibitor.

2. Study phase:

• Collection of baseline demographic data, prior disease history, nature of ICI therapy, outcome data of ICI therapy (treatment disposition, toxicity, tumor response and survival).

• Collection of blood samples will be performed every 3 to 4 weeks for the first year on ICI therapy and every 6 to 12 weeks thereafter until the end of ICI therapy, disease progression, death or loss to follow-up. Collection of blood samples will be aligned with the visits necessary for the administration of the ICI therapy.

• Collection of archival melanoma metastasis tissues will be performed on a continuous basis and be triggered by availability of such tissue following therapeutic resections of melanoma metastases.

3. Follow-up phase

Description:

1. Screen and recruitment: patients will be screened based on their prior history and intention to initiate treatment with an immune checkpoint inhibitor. This screening of candidate patients by the investigators will be non-interventional. Patients that are considered eligible candidates will be invited to participate in this study and to Page 3/18 provide written informed consent.

2. Study phase:

• Collection of baseline demographic data, prior disease history, nature of ICI therapy, outcome data of ICI therapy (treatment disposition, toxicity, tumor response and survival).

• Collection of blood samples will be performed every 3 to 4 weeks for the first year on ICI therapy and every 6 to 12 weeks thereafter until the end of ICI therapy, disease progression, death or loss to follow-up. Collection of blood samples will be aligned with the visits necessary for the administration of the ICI therapy.

• Collection of archival melanoma metastasis tissues will be performed on a continuous basis and be triggered by availability of such tissue following therapeutic resections of melanoma metastases.

3. Follow-up phase: patients who stop treatment with the immune checkpoint inhibitor will be followed-up for

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically confirmed malignant melanoma;

2. AJCC Stage IIIC or IV melanoma with evaluable disease;

3. Treatment with an immune checkpoint inhibitor;

4. Willing and able to give written informed consent;

5. Accessible for treatment and follow-up;

Exclusion Criteria:

• non

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette	Brabant
Belgium	UZ Brussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Ribas A, Kefford R, Marshall MA, Punt CJ, Haanen JB, Marmol M, Garbe C, Gogas H, Schachter J, Linette G, Lorigan P, Kendra KL, Maio M, Trefzer U, Smylie M, McArthur GA, Dreno B, Nathan PD, Mackiewicz J, Kirkwood JM, Gomez-Navarro J, Huang B, Pavlov D, Hau — View Citation

Weber JS, Kudchadkar RR, Yu B, Gallenstein D, Horak CE, Inzunza HD, Zhao X, Martinez AJ, Wang W, Gibney G, Kroeger J, Eysmans C, Sarnaik AA, Chen YA. Safety, efficacy, and biomarkers of nivolumab with vaccine in ipilimumab-refractory or -naive melanoma. J — View Citation

Wilgenhof S, Du Four S, Vandenbroucke F, Everaert H, Salmon I, Liénard D, Marmol VD, Neyns B. Single-center experience with ipilimumab in an expanded access program for patients with pretreated advanced melanoma. J Immunother. 2013 Apr;36(3):215-22. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	explore the value of biomarkers present in blood, and tumor tissue for the purpose of predicting the efficacy of ICI therapy or for the purpose of monitoring the therapeutic effect of ICI therapy	explore the value of biomarkers present in blood, and tumor tissue for the purpose of predicting the efficacy of ICI therapy or for the purpose of monitoring the therapeutic effect of ICI therapy	1year
Secondary	Baseline demographic data, prior disease history, nature of ICI therapy, treatment disposition, adverse events	Baseline demographic data, prior disease history, nature of ICI therapy, treatment disposition, adverse events	1year
Secondary	Tumor response according to the RECISTv1.1 and irRC criteria	Tumor response according to the RECISTv1.1 and irRC criteria	1 year
Secondary	Survival (PFS, and OS) by Kaplan-Meier estimates	Survival (PFS, and OS) by Kaplan-Meier estimates	1year
Secondary	Data collection on the nature and disposition of ICI therapy as well as its efficacy and treatment related adverse events will be collected on a non-interventional basis	Data collection on the nature and disposition of ICI therapy as well as its efficacy and treatment related adverse events will be collected on a non-interventional basis	1 year