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Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma (NADINA)

Primary Purpose

Malignant Melanoma Stage III

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Neoadjuvant ipilimumab + nivolumab
Adjuvant nivolumab
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma Stage III focused on measuring Checkpoint inhibition, Checkpoint inhibitor, Immunotherapy, PD-1 inhibitor, CTLA-4 inhibitor, Ipilimumab, Nivolumab, Neoadjuvant, Adjuvant, Resectable melanoma, NADINA, M21NDN, Checkpoint blockade

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women, at least 16 years of age;
  • World Health Organization (WHO) Performance Status 0 or 1;
  • Cytologically or histologically confirmed resectable stage III melanoma of cutaneous or unknown primary origin with one or more macroscopic lymph node metastases (clinical detectable), that can be biopsied and a maximum of 3 additional resectable in-transit metastases. A concurrent resectable primary melanoma is allowed. Clinical detectable lymph nodes are defined as either a palpable node, confirmed as melanoma by pathology, or a non-palpable but enlarged lymph node according to RECISTv1.1 (at least 15 mm in short axis), confirmed as melanoma by pathology, or a PET scan positive lymph node of any size confirmed as melanoma by pathology;
  • No other malignancies, except adequately treated and with a cancer-related life-expectancy of more than 5 years;
  • No prior immunotherapy targeting CTLA-4, PD-1 or PD-L1;
  • No prior targeted therapy targeting BRAF and/or MEK;
  • No immunosuppressive medications within 6 months prior study inclusion (steroids equivalent to prednisolone ≤10 mg are allowed);
  • Screening laboratory values must meet the following criteria: WBC ≥2.0x109/L, neutrophils ≥1.5x109/L, platelets ≥100x109/L, hemoglobin ≥5.5 mmol/L, creatinine ≤1.5xupper limit of normal (ULN), AST ≤1.5x ULN, ALT ≤1.5x ULN, bilirubin ≤1.5x ULN (except for subjects with Gilbert syndrome who must have a total bilirubin <3.0 mg/dL);
  • LDH level <1.5x ULN;
  • Women of childbearing potential (WOCP) must use appropriate method(s) of contraception, i.e. methods with a failure rate of <1% per year when used consistently and correctly, to avoid pregnancy for 23 weeks post last ipilimumab + nivolumab infusion;
  • Males who are sexually active with WOCP must use appropriate method(s) of contraception, i.e. methods with a failure rate of <1% per year when used consistently and correctly, to avoid pregnancy for 31 weeks post last ipilimumab + nivolumab infusion;
  • Patient willing and able to understand the protocol requirements and comply with the treatment schedule, scheduled visits, electronic patient outcome reporting, tumor biopsies and extra blood withdrawal during screening and in case of recurrence, and other requirements of the study;
  • Patient has signed the Informed Consent document.

Exclusion Criteria:

  • Distantly metastasized melanoma;
  • Uveal/ocular or mucosal melanoma;
  • In-transit metastases only (without cytological or histological proven lymph node involvement)
  • Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications. Subjects with resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, are permitted to enroll;
  • Prior radiotherapy;
  • Subjects will be excluded if they test positive for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV antibody), indicating acute or chronic infection. Subjects treated and being at least one year free from HCV are allowed to participate;
  • Subjects will be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
  • Subjects with history of allergy to study drug components or history of severe hypersensitivity reaction to monoclonal antibodies.
  • Subjects with underlying medical conditions or active infection that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events;
  • Women who are pregnant or breastfeeding;
  • Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids >10 mg prednisolone daily equivalent;
  • Use of other investigational drugs before study drug administration 30 days or 5 half-times before study inclusion;
  • Psychological, familial, sociological, or geographical conditions that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.

Sites / Locations

  • The Angeles Clinic
  • MD Anderson Cancer Center
  • Melanoma Institute Australia (MIA)Recruiting
  • Princess Alexandra Hospital
  • Lake Macquarie Private Hospital
  • Alfred Health
  • Peter MacCallum Cancer CenterRecruiting
  • Fiona Stanley Hospital
  • Tasman OncologyRecruiting
  • Westmead HospitalRecruiting
  • Netherlands Cancer InstituteRecruiting
  • Amsterdam University Medical Center - location VUmcRecruiting
  • Amphia ZiekenhuisRecruiting
  • Maxima Medisch Centrum
  • Medisch Spectrum Twente
  • University Medical Center GroningenRecruiting
  • Zuyderland Medisch CentrumRecruiting
  • Medisch Centrum LeeuwardenRecruiting
  • Leiden University Medical CenterRecruiting
  • Maastricht University Medical CenterRecruiting
  • Radboud University Medical CenterRecruiting
  • Erasmus Medical CenterRecruiting
  • University Medical Center UtrechtRecruiting
  • Isala HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A: Neoadjuvant

B: Adjuvant

Arm Description

2 cycles of neoadjuvant ipilimumab (80mg) + nivolumab (240mg) every 3 weeks followed by a total lymph node dissection (TLND) and if applicable, resection of in-transit metastases. Patients with a pathologic partial or non-response in arm A will also receive adjuvant nivolumab 480 mg every 4 weeks 11 cycles. In case of BRAF V600E/K mutation-positivity, patients will be treated with adjuvant dabrafenib plus trametinib for 46 weeks instead.

Standard upfront total lymph node dissection (TLND) and if applicable, resection of in-transit metastases followed by 12 cycles adjuvant nivolumab 480 mg every 4 weeks

Outcomes

Primary Outcome Measures

Comparison of event-free survival (EFS) in the neoadjuvant and adjuvant group.
EFS is defined as time from randomization to melanoma progression (irresectable stage III or stage IV disease), melanoma recurrence, treatment-related death, or melanoma-related death, whichever occurs first. Occurrence of a new primary melanoma during treatment/follow-up is also regarded as an event. Presurgical resectable progression to stage III disease in arm A is not defined as an event, even as death to another reason than melanoma or the study treatment.

Secondary Outcome Measures

Recurrence free survival (RFS)
RFS is defined as time between date of surgery and date of melanoma recurrence, treatment-related death or melanoma-related death, whichever occurs first.
Distant metastases-free survival (DMFS)
DMFS is defined as time between date of randomization and date of first distant metastasis, treatment-related death or melanoma-related death, whichever occurs first.
Overall survival (OS)
OS is defined as time between date of randomization and date of death.
Pathologic response rate in the neoadjuvant arm and evaluation of association between pathologic response rate and RFS, DMFS and OS.
The pathologic response rate will be categorized into pathologic complete response (pCR), near-pCR, major pathologic response (MPR), pathologic partial response (pPR), pathologic no response (pNR), according to International Neoadjuvant Melanoma Consortium (INMC) criteria.
Rate of immune-related adverse events
Frequency of all grade and grade 3-5 treatment-related adverse events according to CTCAE 5.0.
Duration of immune-related adverse events
Duration of all grade and grade 3-5 treatment-related adverse events according to CTCAE 5.0.
Description of type of immune-related adverse events
Type of all grade and grade 3-5 treatment-related adverse events according to CTCAE 5.0.
Description of surgical morbidity
Surgical complication rates according to Clavien-Dindo surgical classification.
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Quality of life as measured by EORTC Quality of Life Questionnaire-core 30 (QLQ C30). The QLQ-C30 is scored on 4 point Likert-scales: "Not at all", "A little", "Quite a bit", and "Very much." and is composed of both multi-item scales and single-item measures. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Quality of life as measured by the Melanoma Subscale and Melanoma Surgery Subscale of Functional Assessment of Cancer Therapy - Melanoma (FACT-M). The FACT-M is scored on a 5 point Likert-scale: "Not at all", "A little bit", "Somewhat", "Quite a bit", and "Very much.". A Higher score represents higher Health Related Quality of Life (HRQoL).
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Quality of life as measured by the Cancer Worry Scale. The Cancer Worry Scale is scored on a 4 point Likert-scale: "Almost never", "Sometimes", "Often", and "Almost always". Higher scores indicate more worrying about cancer.
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Quality of life as measured by the Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a questionnaire that is scored on several 4 point Likert-scales. Higher score on the HADS questionnaire indicates more hospital-related anxiety and depression.
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Quality of life as measured by the 5-level EuroQOL-5D questionnaire (EQ-5D-5L).
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Quality of life as measured by an immunotherapy-specific questionnaire.
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Quality of life as measured by an assessment of work performance.
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Quality of life as measured by a questionnaire on sexual health.
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Quality of life as measured by the Amsterdam Cognition Scale.
Health technology assessments, consisting of a cost-effectiveness analysis comparing the neoadjuvant arm with the standard adjuvant arm
Cost-effectiveness measured by an incremental cost-effectiveness ratio (ICER) (e.g., incremental cost per quality-adjusted life-year (QALY) gained).

Full Information

First Posted
June 16, 2021
Last Updated
October 9, 2023
Sponsor
The Netherlands Cancer Institute
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04949113
Brief Title
Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma
Acronym
NADINA
Official Title
Multicenter Phase 3 Trial Comparing Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma - NADINA
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute
Collaborators
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an international (Australia, Europe, and USA) open-label two-arm randomized phase 3 trial including 420 stage III (≤3 resectable in-transit metastases allowed) cutaneous or unknown primary melanoma patients. Patients will be randomized 1:1 to receive either 2 cycles of neoadjuvant ipilimumab 80 mg + nivolumab 240 mg every 3 weeks followed by a total lymph node dissection (TLND) and, if applicable, resection of in-transit metastases (arm A) versus standard upfront TLND +/- resection of in-transit metastases followed by 12 cycles adjuvant nivolumab 480 mg every 4 weeks (arm B). Patients with a pathologic partial or non-response in arm A will also receive adjuvant nivolumab 480 mg every 4 weeks for 46 weeks (11 cycles). In case of BRAF V600E/K mutation-positivity, patients from arm A with a pathologic partial or non-response (>10% viable tumor) will be treated with adjuvant dabrafenib plus trametinib for 46 weeks. Patients will be treated in the study in both arms until melanoma progression to irresectable stage III or stage IV disease, disease recurrence, unacceptable toxicity, subject withdrawal of consent or until end of study treatment. An interim analysis will be performed after 60 events have occurred. The data safety monitory board (DSMB) will be ad hoc consulted when unexpected toxicities are reported. Patients will be followed by 12 weekly CT scans until end of year 3 and then until year 5 according to the institute's standards.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma Stage III
Keywords
Checkpoint inhibition, Checkpoint inhibitor, Immunotherapy, PD-1 inhibitor, CTLA-4 inhibitor, Ipilimumab, Nivolumab, Neoadjuvant, Adjuvant, Resectable melanoma, NADINA, M21NDN, Checkpoint blockade

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Open-label two-arm randomized phase 3 trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: Neoadjuvant
Arm Type
Experimental
Arm Description
2 cycles of neoadjuvant ipilimumab (80mg) + nivolumab (240mg) every 3 weeks followed by a total lymph node dissection (TLND) and if applicable, resection of in-transit metastases. Patients with a pathologic partial or non-response in arm A will also receive adjuvant nivolumab 480 mg every 4 weeks 11 cycles. In case of BRAF V600E/K mutation-positivity, patients will be treated with adjuvant dabrafenib plus trametinib for 46 weeks instead.
Arm Title
B: Adjuvant
Arm Type
Active Comparator
Arm Description
Standard upfront total lymph node dissection (TLND) and if applicable, resection of in-transit metastases followed by 12 cycles adjuvant nivolumab 480 mg every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Neoadjuvant ipilimumab + nivolumab
Other Intervention Name(s)
Yervoy + Opdivo
Intervention Description
2 cycles ipilimumab (80mg) + nivolumab (240mg) every 3 weeks followed by total lymph node dissection
Intervention Type
Drug
Intervention Name(s)
Adjuvant nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
Upfront total lymph node dissection followed by 12 cycles of nivolumab (480mg) every 4 weeks.
Primary Outcome Measure Information:
Title
Comparison of event-free survival (EFS) in the neoadjuvant and adjuvant group.
Description
EFS is defined as time from randomization to melanoma progression (irresectable stage III or stage IV disease), melanoma recurrence, treatment-related death, or melanoma-related death, whichever occurs first. Occurrence of a new primary melanoma during treatment/follow-up is also regarded as an event. Presurgical resectable progression to stage III disease in arm A is not defined as an event, even as death to another reason than melanoma or the study treatment.
Time Frame
Analysis will be performed after 132 events, though not later than after 2 years follow-up of all patients.
Secondary Outcome Measure Information:
Title
Recurrence free survival (RFS)
Description
RFS is defined as time between date of surgery and date of melanoma recurrence, treatment-related death or melanoma-related death, whichever occurs first.
Time Frame
Up to 5 years after randomization
Title
Distant metastases-free survival (DMFS)
Description
DMFS is defined as time between date of randomization and date of first distant metastasis, treatment-related death or melanoma-related death, whichever occurs first.
Time Frame
Up to 5 years after randomization
Title
Overall survival (OS)
Description
OS is defined as time between date of randomization and date of death.
Time Frame
Up to 5 years after randomization
Title
Pathologic response rate in the neoadjuvant arm and evaluation of association between pathologic response rate and RFS, DMFS and OS.
Description
The pathologic response rate will be categorized into pathologic complete response (pCR), near-pCR, major pathologic response (MPR), pathologic partial response (pPR), pathologic no response (pNR), according to International Neoadjuvant Melanoma Consortium (INMC) criteria.
Time Frame
Up to 5 years after randomization
Title
Rate of immune-related adverse events
Description
Frequency of all grade and grade 3-5 treatment-related adverse events according to CTCAE 5.0.
Time Frame
Up to 5 years after randomization
Title
Duration of immune-related adverse events
Description
Duration of all grade and grade 3-5 treatment-related adverse events according to CTCAE 5.0.
Time Frame
Up to 5 years after randomization
Title
Description of type of immune-related adverse events
Description
Type of all grade and grade 3-5 treatment-related adverse events according to CTCAE 5.0.
Time Frame
Up to 5 years after randomization
Title
Description of surgical morbidity
Description
Surgical complication rates according to Clavien-Dindo surgical classification.
Time Frame
Up to 5 years after randomization
Title
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Description
Quality of life as measured by EORTC Quality of Life Questionnaire-core 30 (QLQ C30). The QLQ-C30 is scored on 4 point Likert-scales: "Not at all", "A little", "Quite a bit", and "Very much." and is composed of both multi-item scales and single-item measures. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time Frame
Up to 5 years after randomization
Title
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Description
Quality of life as measured by the Melanoma Subscale and Melanoma Surgery Subscale of Functional Assessment of Cancer Therapy - Melanoma (FACT-M). The FACT-M is scored on a 5 point Likert-scale: "Not at all", "A little bit", "Somewhat", "Quite a bit", and "Very much.". A Higher score represents higher Health Related Quality of Life (HRQoL).
Time Frame
Up to 5 years after randomization
Title
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Description
Quality of life as measured by the Cancer Worry Scale. The Cancer Worry Scale is scored on a 4 point Likert-scale: "Almost never", "Sometimes", "Often", and "Almost always". Higher scores indicate more worrying about cancer.
Time Frame
Up to 5 years after randomization
Title
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Description
Quality of life as measured by the Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a questionnaire that is scored on several 4 point Likert-scales. Higher score on the HADS questionnaire indicates more hospital-related anxiety and depression.
Time Frame
Up to 5 years after randomization
Title
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Description
Quality of life as measured by the 5-level EuroQOL-5D questionnaire (EQ-5D-5L).
Time Frame
Up to 5 years after randomization
Title
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Description
Quality of life as measured by an immunotherapy-specific questionnaire.
Time Frame
Up to 5 years after randomization
Title
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Description
Quality of life as measured by an assessment of work performance.
Time Frame
Up to 5 years after randomization
Title
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Description
Quality of life as measured by a questionnaire on sexual health.
Time Frame
Up to 5 years after randomization
Title
Evaluation of health-related quality of life (HRQoL) in both treatment arms
Description
Quality of life as measured by the Amsterdam Cognition Scale.
Time Frame
Up to 5 years after randomization
Title
Health technology assessments, consisting of a cost-effectiveness analysis comparing the neoadjuvant arm with the standard adjuvant arm
Description
Cost-effectiveness measured by an incremental cost-effectiveness ratio (ICER) (e.g., incremental cost per quality-adjusted life-year (QALY) gained).
Time Frame
Up to 5 years after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women, at least 16 years of age; World Health Organization (WHO) Performance Status 0 or 1; Cytologically or histologically confirmed resectable stage III melanoma of cutaneous or unknown primary origin with one or more macroscopic lymph node metastases (clinical detectable), that can be biopsied and a maximum of 3 additional resectable in-transit metastases. A concurrent resectable primary melanoma is allowed. Clinical detectable lymph nodes are defined as either a palpable node, confirmed as melanoma by pathology, or a non-palpable but enlarged lymph node according to RECISTv1.1 (at least 15 mm in short axis), confirmed as melanoma by pathology, or a PET scan positive lymph node of any size confirmed as melanoma by pathology; No other malignancies, except adequately treated and with a cancer-related life-expectancy of more than 5 years; No prior immunotherapy targeting CTLA-4, PD-1 or PD-L1; No prior targeted therapy targeting BRAF and/or MEK; No immunosuppressive medications within 6 months prior study inclusion (steroids equivalent to prednisolone ≤10 mg are allowed); Screening laboratory values must meet the following criteria: WBC ≥2.0x109/L, neutrophils ≥1.5x109/L, platelets ≥100x109/L, hemoglobin ≥5.5 mmol/L, creatinine ≤1.5xupper limit of normal (ULN), AST ≤1.5x ULN, ALT ≤1.5x ULN, bilirubin ≤1.5x ULN (except for subjects with Gilbert syndrome who must have a total bilirubin <3.0 mg/dL); LDH level <1.5x ULN; Women of childbearing potential (WOCP) must use appropriate method(s) of contraception, i.e. methods with a failure rate of <1% per year when used consistently and correctly, to avoid pregnancy for 23 weeks post last ipilimumab + nivolumab infusion; Males who are sexually active with WOCP must use appropriate method(s) of contraception, i.e. methods with a failure rate of <1% per year when used consistently and correctly, to avoid pregnancy for 31 weeks post last ipilimumab + nivolumab infusion; Patient willing and able to understand the protocol requirements and comply with the treatment schedule, scheduled visits, electronic patient outcome reporting, tumor biopsies and extra blood withdrawal during screening and in case of recurrence, and other requirements of the study; Patient has signed the Informed Consent document. Exclusion Criteria: Distantly metastasized melanoma; Uveal/ocular or mucosal melanoma; In-transit metastases only (without cytological or histological proven lymph node involvement) Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications. Subjects with resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, are permitted to enroll; Prior radiotherapy; Subjects will be excluded if they test positive for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV antibody), indicating acute or chronic infection. Subjects treated and being at least one year free from HCV are allowed to participate; Subjects will be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); Subjects with history of allergy to study drug components or history of severe hypersensitivity reaction to monoclonal antibodies. Subjects with underlying medical conditions or active infection that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events; Women who are pregnant or breastfeeding; Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids >10 mg prednisolone daily equivalent; Use of other investigational drugs before study drug administration 30 days or 5 half-times before study inclusion; Psychological, familial, sociological, or geographical conditions that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Blank, Prof
Phone
+31205129111
Email
c.blank@nki.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Blank, Prof
Organizational Affiliation
Medical oncologist/researcher
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Georgina Long, Prof
Organizational Affiliation
Medical oncologist/researcher
Official's Role
Study Chair
Facility Information:
Facility Name
The Angeles Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Melanoma Institute Australia (MIA)
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgina Long, Prof
Facility Name
Princess Alexandra Hospital
City
Brisbane
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Lake Macquarie Private Hospital
City
Gateshead
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Alfred Health
City
Melbourne
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Peter MacCallum Cancer Center
City
Melbourne
Country
Australia
Individual Site Status
Recruiting
Facility Name
Fiona Stanley Hospital
City
Murdoch
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Tasman Oncology
City
Southport
Country
Australia
Individual Site Status
Recruiting
Facility Name
Westmead Hospital
City
Sydney
Country
Australia
Individual Site Status
Recruiting
Facility Name
Netherlands Cancer Institute
City
Amsterdam
State/Province
NH
ZIP/Postal Code
1066CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Blank, Prof
Facility Name
Amsterdam University Medical Center - location VUmc
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Amphia Ziekenhuis
City
Breda
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Maxima Medisch Centrum
City
Eindhoven
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Leiden University Medical Center
City
Leiden
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Radboud University Medical Center
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
University Medical Center Utrecht
City
Utrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Isala Hospital
City
Zwolle
Country
Netherlands
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma

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