Multicenter Phase 2 Study to Identify the Optimal neo-Adjuvant Combination Scheme of Ipilimumab and Nivolumab (OpACIN-neo) and Personalized Response-driven Adjuvant Combination (PRADO extension cohort)

Phase 2

Recruiting

• Conditions: melanoma; skin cancer; 10040900

• Registration Number: NL-OMON50672
• Lead Sponsor: ederlands Kanker Instituut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

• Adults at least 18 years of age
• World Health Organization (WHO) Performance Status 0 or 1
• Cytologically and histologically confirmed resectable stage III melanoma with
one or more macroscopic lymph node metastases (measurable according to RECIST
1.1), that can be biopsied, and no history of in-transit metastases within the
last 6 months
• No other malignancies, except adequately treated and a cancer-related
life-expectancy of more than 5 years
• Patient willing to undergo triple tumor biopsies and extra blood withdrawal
during screening and in case of relapse
• No prior immunotherapy targeting CTLA-4, PD-1 or PD-L1
• No immunosuppressive medications within 6 months prior study inclusion
• Screening laboratory values must meet the following criteria: WBC >=
2.0x109/L, Neutrophils >=1.5x109/L, Platelets >=100 x109/L, Hemoglobin >=5.5
mmol/L, Creatinine <=1.5x ULN, AST <= 1.5 x ULN, ALT <= 1.5 x ULN, Bilirubin <=1.5
X ULN
• Normal LDH

Exclusion Criteria

• Distantly metastasized melanoma
• Brain metastases
• History of in-transit metastases within the last 6 months
• No measurable lesion according to RECIST 1.1
• Subjects with any active autoimmune disease or a documented history of
autoimmune disease, or history of syndrome that required systemic steroids or
immunosuppressive medications, except for subjects with vitiligo or resolved
childhood asthma/atopy
• Prior CTLA-4 or PD-1/PD-L1 targeting immunotherapy
• Radiotherapy prior or post-surgery (except for non-responders in PRADO
extension cohort; in this group is adjuvant radiotherapy allowed)
• Patients who test positive for hepatitis B or C or HIV.

Study & Design

• Study Type: Interventional
• Study Design: Not specified