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Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C Melanoma Patients (NeoDREAM)

Primary Purpose

Melanoma Stage IIIB/C

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Daromun
Surgery
Adjuvant therapy
Sponsored by
Philogen S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma Stage IIIB/C

Eligibility Criteria

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

Inclusion Criteria:

  1. Diagnosis of clinical stage IIIB and IIIC (AJCC v7) metastatic melanoma, eligible for complete surgical resection of all metastases (surgically resectable).
  2. Eligible subjects must have measurable disease and must be candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion (≥ 10 mm in longest diameter) or with multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm.
  3. Males or females, age ≥ 18 years.
  4. ECOG Performance Status/WHO Performance Status ≤ 1.
  5. Life expectancy of > 24 months.
  6. Absolute neutrophil count > 1.5 x 109/L.
  7. Hemoglobin > 9.0 g/dL.
  8. Platelets > 100 x 109/L.
  9. Total bilirubin ≤ 30 µmol/L (or ≤ 2.0 mg/dl).
  10. ALT and AST ≤ 2.5 x the upper limit of normal (ULN).
  11. Serum creatinine < 1.5 x ULN .
  12. LDH serum level ≤ 1.5 x ULN.
  13. Documented negative test for HIV, HBV and HCV. For HBV serology, the determination of HBsAg, and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV negative serum HBV-DNA is also required.
  14. All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v4.03) Grade ≤ 1 unless otherwise specified above.
  15. All women of childbearing potential (WOCBP) must have negative pregnancy test results at the screening. WOCBP must be using, from the screening to three months following the last study drug administration, highly effective contraception methods. WOCBP and effective contraception methods are defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence. Pregnancy test will be repeated at the safety visit (only WOCBP and only for patients in Arm 1).
  16. Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration.
  17. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  18. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

  1. Uveal melanoma or mucosal melanoma
  2. Evidence of distant metastases at screening.
  3. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except: cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1), second primary melanoma in situ or any cancer curatively treated ≥ 5 years prior to study entry.
  4. Presence of active infections (e.g. requiring antimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
  5. History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
  6. Inadequately controlled cardiac arrhythmias including atrial fibrillation.
  7. Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria).
  8. LVEF ≤ 50% and/or abnormalities observed during baseline ECG and Echocardiogram investigations that are considered as clinically significant by the investigator.
  9. Uncontrolled hypertension.
  10. Ischemic peripheral vascular disease (Grade IIb-IV).
  11. Severe diabetic retinopathy.
  12. Active autoimmune disease.
  13. History of organ allograft or stem cell transplantation.
  14. Recovery from major trauma including surgery within 4 weeks prior to enrollment.
  15. Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies or any other constituent of the product.
  16. Breast feeding female.
  17. Anti-tumor therapy (except small surgery) within 4 weeks before enrollment.
  18. Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before enrollment.
  19. Planned administration of growth factors or immunomodulatory agents within 7 days before enrollment.
  20. Patient requiring or taking corticosteroids or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion.
  21. Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.
  22. Previous enrolment and randomization in the same study.

Sites / Locations

  • Mayo Clinic HospitalRecruiting
  • UC San Diego Moores Cancer CenterRecruiting
  • UC Irvine Health-Chao Family Comprehensive Cancer CenterRecruiting
  • Moffitt Cancer CenterRecruiting
  • Winship Cancer InstituteRecruiting
  • Rush University Cancer Center - - 1750 W. Harrison Street, Jelke 601Recruiting
  • University of Iowa Hospitals and ClinicsRecruiting
  • Mayo ClinicRecruiting
  • Rutgers Cancer Institute, 195 Little Albany StreetRecruiting
  • Duke University Medical Center - Duke Cancer CenterRecruiting
  • Ohio State University Wexner Medical CenterRecruiting
  • St. Luke's Cancer Center, Clinical Trial, 3rd floor, 1600 St. Luke's Blvd.Recruiting
  • Penn State Cancer InstituteRecruiting
  • Fox Chase Cancer Center 333 Cottman AvenueRecruiting
  • Huntsman Cancer Institute, University of Utah 2000 Circle of HopeRecruiting
  • Hospital Clinic BarcelonaRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital Universitari Germans Trias i PujolRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Teresa Herrera
  • Hospital Universitario DonostiaRecruiting
  • HU Gran Canaria Doctor NegrinRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • MD Anderson MadridRecruiting
  • Hospital Clínico Universitario Virgen de la ArrixacaRecruiting
  • Hospital Universitario Regional de MálagaRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting
  • Hospital General Universitario de ValenciaRecruiting
  • Universitätsspital BaselRecruiting
  • Istituto Oncologico della Svizzera ItalianaRecruiting
  • Universitätsspital Inselspital BernRecruiting
  • Hôpitaux Universitaires de GenèveRecruiting
  • Kantonsspital St.GallenRecruiting
  • Universitätsspital Zürich (USZ)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Daromun plus Surgery and Adjuvant therapy (Arm 1)

Surgery and adjuvant therapy (Arm 2)

Arm Description

Two-weeks screening period and a 4-weeks open-label treatment period, followed by surgery within a maximum of another 4 weeks and adjuvant therapy (Arm 1).

Patients in the control arm (Arm 2) will receive direct surgery within 4 weeks from randomization, followed by adjuvant therapy.

Outcomes

Primary Outcome Measures

Recurrence Free Survival (RFS)
RFS in the Daromun plus surgery and adjuvant therapy treatment group (Arm 1) versus surgery and adjuvant therapy (Arm 2). RFS is defined as the difference between date of randomization (which represents Day 0 for both arms) and the date of first recurrence (local, regional, distant or new primary melanoma, whichever comes first) or death.

Secondary Outcome Measures

Overall survival (OS)
OS in the Daromun plus surgery and adjuvant therapy treatment group (Arm 1) versus surgery and adjuvant therapy (Arm 2). OS is defined as the difference between date of randomization (which represents Day 0 for both arms) and the date of death.
Recurrence free survival (RFS) as determined by the local investigator
RFS after randomization in the Daromun plus surgery and adjuvant therapy treatment group (Arm 1) versus surgery and adjuvant therapy (Arm 2). RFS is defined as the difference between date of randomization (which represents Day 0 for both arms) and the date of first recurrence (local, regional, distant or new primary melanoma, whichever comes first) or death.
Pathological response (only for patients in Arm 1)
Categorization of pathological response as: p Complete Response, p near-Complete Response, p Partial Response, p None Response
Adverse Events (AE)
Percentage of Patients in Each Treatment Group with AEs, AEs with CTCAE grade ≥3
Serious Adverse Event (SAEs)
Percentage of Patients in Each Treatment Group with Drug-Related Adverse Events, Serious Adverse Event (SAEs)
Drug-Induced Liver Injury (DILI)
Number of patients with Drug-Induced Liver Injury (DILI)
Adverse Events of Special Interest (AESI)
Number of patients with Adverse Events of Special Interest (AESI)
Percentage of Subjects with Haematological/chemical Laboratory Abnormalities
Percentage of participants with Electrocardiogram (ECG) and echocardiogram (ECHO) abnormality findings.
Data about QT/QTc intervals will be collected and analysed for QT/QTc prolongation potentially caused by treatment.
Number of subjects with a clinically significant change from baseline in physical examination
Concomitant medication
Number of subject with concomitant medication
Human anti-fusion protein antibodies (HAFA)
Assessment of the formation of human anti-fusion protein antibodies (HAFA) against L19IL2 and L19TNF
Vital signs (blood pressure)
Number of subjects with a clinically significant change from baseline in vital signs (blood pressure) by visit
Number of subjects with a clinically significant change from baseline in vital signs (heart rate) by visit
Number of subjects with a clinically significant change from baseline in vital signs (body temperature) by visit

Full Information

First Posted
May 18, 2018
Last Updated
October 5, 2023
Sponsor
Philogen S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03567889
Brief Title
Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C Melanoma Patients
Acronym
NeoDREAM
Official Title
An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy Versus Surgery and Adjuvant Therapy in Clinical Stage IIIB/C Melanoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philogen S.p.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The trial aims to evaluate the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery and adjuvant therapy).
Detailed Description
The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of Daromun neoadjuvant intratumoral treatment followed by surgery and adjuvant therapy versus surgery and adjuvant therapy in clinical stage III B/C melanoma patients. 186 patients will be randomized in a 1:1 ratio to receive Daromun treatment followed by surgery and adjuvant therapy (Arm 1) or surgery and adjuvant therapy (Arm 2). In both arms, follow-up for assessing recurrence-free survival will be performed up to five years after randomization. Survival information will also be collected in the following year (up to six years in total after randomization). This is an open-label study, so there is no blinding. Patients who successfully complete the screening evaluations and are eligible for participation in the study will be enrolled and randomly assigned (1:1) to two parallel treatment arms: Daromun plus surgery and adjuvant therapy (Arm 1) or surgery and adjuvant therapy (Arm 2). To ensure a balance across treatment groups, stratified randomization with permuted block will be used and separate randomization list for each subgroup (stratum) will be produced. Patients will be stratified on the basis of the following prognostic factors: Stage of disease (2 levels): Stage IIIB vs. Stage IIIC Planned post-surgical adjuvant therapy (2 levels): anti-PD-1 and other adjuvant therapies. The primary objective of the study is to demonstrate that a neoadjuvant Daromun treatment followed by surgery and adjuvant therapy improves in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery and adjuvant therapy). Primary endpoint of the study is RFS in a time-to-event analysis in the Daromun plus surgery and adjuvant therapy treatment group (Arm 1) versus the surgery plus adjuvant therapy control group (Arm 2). Analysis will be based on the "Intention To Treat" population. The key secondary objective of the study is to demonstrate that a neoadjuvant Daromun treatment followed by surgery and adjuvant therapy improves in a statistically significant manner the overall survival (OS) of patients with resectable Stage IIIB/ or C melanoma patients with respect to the standard of care (surgery and adjuvant therapy). For patients enrolled in both arms, local approved post-surgery adjuvant therapies (as part of the standard of care) are allowed and decided at the investigator's discretion. These include high-dose interferon- α2b, anti-CTLA-4 antibodies (e.g. Ipilimumab), anti-PD1 antibodies (e.g. Nivolumab, Pembrolizumab), targeted therapies (e.g. Dabrafenib + Trametinib), or other new local approved treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma Stage IIIB/C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Total patients: approximately 186. Daromun plus surgery and adjuvant therapy treatment group (Arm 1): 93 evaluable patients. Surgery and adjuvant therapy (Arm 2): 93 evaluable patients. Patients enrolled will be randomized to the two different arms of the study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Daromun plus Surgery and Adjuvant therapy (Arm 1)
Arm Type
Experimental
Arm Description
Two-weeks screening period and a 4-weeks open-label treatment period, followed by surgery within a maximum of another 4 weeks and adjuvant therapy (Arm 1).
Arm Title
Surgery and adjuvant therapy (Arm 2)
Arm Type
Active Comparator
Arm Description
Patients in the control arm (Arm 2) will receive direct surgery within 4 weeks from randomization, followed by adjuvant therapy.
Intervention Type
Drug
Intervention Name(s)
Daromun
Intervention Description
Patients will receive intratumoral administrations into injectable cutaneous, subcutaneous, and nodal tumors of Daromun once weekly for up to 4 weeks. Surgery will follow within 4 weeks.
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Patients in Arm 2 will receive surgery within 4 weeks from randomisation.
Intervention Type
Drug
Intervention Name(s)
Adjuvant therapy
Intervention Description
Patients will receive adjuvant therapy at the investigator's discretion following the surgery.
Primary Outcome Measure Information:
Title
Recurrence Free Survival (RFS)
Description
RFS in the Daromun plus surgery and adjuvant therapy treatment group (Arm 1) versus surgery and adjuvant therapy (Arm 2). RFS is defined as the difference between date of randomization (which represents Day 0 for both arms) and the date of first recurrence (local, regional, distant or new primary melanoma, whichever comes first) or death.
Time Frame
From date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first assessed up to 60 months.
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
OS in the Daromun plus surgery and adjuvant therapy treatment group (Arm 1) versus surgery and adjuvant therapy (Arm 2). OS is defined as the difference between date of randomization (which represents Day 0 for both arms) and the date of death.
Time Frame
From date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first, assessed up to 72 months.
Title
Recurrence free survival (RFS) as determined by the local investigator
Description
RFS after randomization in the Daromun plus surgery and adjuvant therapy treatment group (Arm 1) versus surgery and adjuvant therapy (Arm 2). RFS is defined as the difference between date of randomization (which represents Day 0 for both arms) and the date of first recurrence (local, regional, distant or new primary melanoma, whichever comes first) or death.
Time Frame
From date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first assessed up to 60 months.
Title
Pathological response (only for patients in Arm 1)
Description
Categorization of pathological response as: p Complete Response, p near-Complete Response, p Partial Response, p None Response
Time Frame
Time Frame: Assessed at the time of surgical resection of the tumor lesions
Title
Adverse Events (AE)
Description
Percentage of Patients in Each Treatment Group with AEs, AEs with CTCAE grade ≥3
Time Frame
From the inclusion in the study (signature of the informed consent form - ICF) until the first follow-up visit (up to approximately 5 months).
Title
Serious Adverse Event (SAEs)
Description
Percentage of Patients in Each Treatment Group with Drug-Related Adverse Events, Serious Adverse Event (SAEs)
Time Frame
From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months).
Title
Drug-Induced Liver Injury (DILI)
Description
Number of patients with Drug-Induced Liver Injury (DILI)
Time Frame
From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months).
Title
Adverse Events of Special Interest (AESI)
Description
Number of patients with Adverse Events of Special Interest (AESI)
Time Frame
From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months).
Title
Percentage of Subjects with Haematological/chemical Laboratory Abnormalities
Time Frame
From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months).
Title
Percentage of participants with Electrocardiogram (ECG) and echocardiogram (ECHO) abnormality findings.
Description
Data about QT/QTc intervals will be collected and analysed for QT/QTc prolongation potentially caused by treatment.
Time Frame
1) day 0-14 (screening) for both arm; 2) at week 5 (Safety assessment) only for arm 1.
Title
Number of subjects with a clinically significant change from baseline in physical examination
Time Frame
From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months)
Title
Concomitant medication
Description
Number of subject with concomitant medication
Time Frame
From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months)
Title
Human anti-fusion protein antibodies (HAFA)
Description
Assessment of the formation of human anti-fusion protein antibodies (HAFA) against L19IL2 and L19TNF
Time Frame
1) day 0-14 (screening) for arm 1; 2) at week 5 (Safety assessment) for Arm 1; 3) at week 12 (only first follow-up) for Arm 1.
Title
Vital signs (blood pressure)
Description
Number of subjects with a clinically significant change from baseline in vital signs (blood pressure) by visit
Time Frame
From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months).
Title
Number of subjects with a clinically significant change from baseline in vital signs (heart rate) by visit
Time Frame
From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months)
Title
Number of subjects with a clinically significant change from baseline in vital signs (body temperature) by visit
Time Frame
From the inclusion in the study (signature of the informed consent form - ICF) until the end of follow-up (up to approximately 60 months)
Other Pre-specified Outcome Measures:
Title
Local recurrence-free survival (LRFS)
Description
LRFS after randomization in the Daromun plus surgery and adjuvant therapy treatment group (Arm 1) versus surgery and adjuvant therapy (Arm 2). LRFS is defined as survival free of loco-regional recurrence occurring at any time before systemic recurrence and other events are censored
Time Frame
From date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first assessed up to 60 months
Title
Distant metastasis-free survival (DMFS)
Description
DMFS after randomization in the Daromun plus surgery and adjuvant therapy treatment group (Arm 1) versus surgery and adjuvant therapy (Arm 2). DMFS is defined as survival free of systemic recurrence, including: 1) systemic recurrence outside the locoregional area at any time before or after loco-regional relapse, 2) systemic recurrence with or without loco-regional relapse, or 3) death from cancer with no information on systemic recurrence
Time Frame
From date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first assessed up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of clinical stage IIIB and IIIC (AJCC v7) metastatic melanoma, eligible for complete surgical resection of all metastases (surgically resectable). Eligible subjects must have measurable disease and must be candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion (≥ 10 mm in longest diameter) or with multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm. Males or females, age ≥ 18 years. ECOG Performance Status/WHO Performance Status ≤ 1. Life expectancy of > 24 months. Absolute neutrophil count > 1.5 x 109/L. Hemoglobin > 9.0 g/dL. Platelets > 100 x 109/L. Total bilirubin ≤ 30 µmol/L (or ≤ 2.0 mg/dl). ALT and AST ≤ 2.5 x the upper limit of normal (ULN). Serum creatinine < 1.5 x ULN . LDH serum level ≤ 1.5 x ULN. Documented negative test for HIV, HBV and HCV. For HBV serology, the determination of HBsAg, and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV negative serum HBV-DNA is also required. All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v4.03) Grade ≤ 1 unless otherwise specified above. All women of childbearing potential (WOCBP) must have negative pregnancy test results at the screening. WOCBP must be using, from the screening to three months following the last study drug administration, highly effective contraception methods. WOCBP and effective contraception methods are defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence. Pregnancy test will be repeated at the safety visit (only WOCBP and only for patients in Arm 1). Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures. Exclusion Criteria: Uveal melanoma or mucosal melanoma Evidence of distant metastases at screening. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except: cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1), second primary melanoma in situ or any cancer curatively treated ≥ 5 years prior to study entry. Presence of active infections (e.g. requiring antimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study. History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris. Inadequately controlled cardiac arrhythmias including atrial fibrillation. Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria). LVEF ≤ 50% and/or abnormalities observed during baseline ECG and Echocardiogram investigations that are considered as clinically significant by the investigator. Uncontrolled hypertension. Ischemic peripheral vascular disease (Grade IIb-IV). Severe diabetic retinopathy. Active autoimmune disease. History of organ allograft or stem cell transplantation. Recovery from major trauma including surgery within 4 weeks prior to enrollment. Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies or any other constituent of the product. Breast feeding female. Anti-tumor therapy (except small surgery) within 4 weeks before enrollment. Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before enrollment. Planned administration of growth factors or immunomodulatory agents within 7 days before enrollment. Patient requiring or taking corticosteroids or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion. Any conditions that in the opinion of the investigator could hamper compliance with the study protocol. Previous enrolment and randomization in the same study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niccolò Ravenni, PhD
Phone
+39057717816
Email
regulatory@philogen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Giuliano Elia, PhD
Phone
+39057717816
Email
regulatory@philogen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan S Zager, MD FACS
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Pockaj, MD
First Name & Middle Initial & Last Name & Degree
Barbara Pockaj, MD
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel Baumgartner
First Name & Middle Initial & Last Name & Degree
Joel Baumgartner, MD
Facility Name
UC Irvine Health-Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Warren Chow
First Name & Middle Initial & Last Name & Degree
Warren Chow, MD
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Zager
First Name & Middle Initial & Last Name & Degree
Jonathan Zager, MD
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Lowe
First Name & Middle Initial & Last Name & Degree
Michael Lowe, MD
Facility Name
Rush University Cancer Center - - 1750 W. Harrison Street, Jelke 601
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina O'Donoghue
First Name & Middle Initial & Last Name & Degree
Cristina O'Donoghue, MD
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Milhem
First Name & Middle Initial & Last Name & Degree
Mohammed Milhem, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anastasios Dimou, MD
First Name & Middle Initial & Last Name & Degree
Anastasios Dimou, MD
Facility Name
Rutgers Cancer Institute, 195 Little Albany Street
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Berger
First Name & Middle Initial & Last Name & Degree
Adam Berger, MD
Facility Name
Duke University Medical Center - Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgia Beasley
First Name & Middle Initial & Last Name & Degree
Georgia Beasley
Facility Name
Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Verschraegen
First Name & Middle Initial & Last Name & Degree
Claire Verschraegen, MD
Facility Name
St. Luke's Cancer Center, Clinical Trial, 3rd floor, 1600 St. Luke's Blvd.
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Wilson
First Name & Middle Initial & Last Name & Degree
Melissa Wilson, MD
Facility Name
Penn State Cancer Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Drabick
Facility Name
Fox Chase Cancer Center 333 Cottman Avenue
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Farma
First Name & Middle Initial & Last Name & Degree
Jeffrey Farma, MD
Facility Name
Huntsman Cancer Institute, University of Utah 2000 Circle of Hope
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Hyngstrom
First Name & Middle Initial & Last Name & Degree
John Hyngstrom
Facility Name
Hospital Clinic Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josep Malvehy Guilera
First Name & Middle Initial & Last Name & Degree
Josep Malvehy Guilera
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margarita Majem Tarruella
First Name & Middle Initial & Last Name & Degree
Margarita Majem Tarruella
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Luis Manzano Mozo
First Name & Middle Initial & Last Name & Degree
José Luis Manzano Mozo
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Muñoz Couselo
First Name & Middle Initial & Last Name & Degree
Eva Muñoz Couselo
Facility Name
Hospital Teresa Herrera
City
Coruña
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Quindós Varela
First Name & Middle Initial & Last Name & Degree
María Quindós Varela
Facility Name
Hospital Universitario Donostia
City
Donostia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karmele Mujika Eizmendi
First Name & Middle Initial & Last Name & Degree
Karmele Mujika Eizmendi
Facility Name
HU Gran Canaria Doctor Negrin
City
Las Palmas De Gran Canaria
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Luis Ortiz Romero
First Name & Middle Initial & Last Name & Degree
Pedro Luis Ortiz Romero
Facility Name
MD Anderson Madrid
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pilar López Criado
First Name & Middle Initial & Last Name & Degree
Pilar López Criado
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
Murcia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Cerezuela Fuentes
First Name & Middle Initial & Last Name & Degree
Pablo Cerezuela Fuentes
Facility Name
Hospital Universitario Regional de Málaga
City
Málaga
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Pérez Ruiz
First Name & Middle Initial & Last Name & Degree
Elisabeth Pérez Ruiz
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Moreno Ramírez
First Name & Middle Initial & Last Name & Degree
David Moreno Ramírez
Facility Name
Hospital General Universitario de Valencia
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfonso Berrocal Jaime
First Name & Middle Initial & Last Name & Degree
Alfonso Berrocal Jaime
Facility Name
Universitätsspital Basel
City
Basel
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Navarini
First Name & Middle Initial & Last Name & Degree
Alexander Navarini
Facility Name
Istituto Oncologico della Svizzera Italiana
City
Bellinzona
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Mangas
First Name & Middle Initial & Last Name & Degree
Cristina Mangas
Facility Name
Universitätsspital Inselspital Bern
City
Bern
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Hunger
First Name & Middle Initial & Last Name & Degree
Robert Hunger
Facility Name
Hôpitaux Universitaires de Genève
City
Genève
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rastine Mérat
First Name & Middle Initial & Last Name & Degree
Rastine Mérat
Facility Name
Kantonsspital St.Gallen
City
Saint Gallen
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolaus Wagner
First Name & Middle Initial & Last Name & Degree
Nikolaus Wagner
Facility Name
Universitätsspital Zürich (USZ)
City
Zürich
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Egle Ramelyte
First Name & Middle Initial & Last Name & Degree
Egle Ramelyte

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31538818
Citation
Miura JT, Zager JS. Neo-DREAM study investigating Daromun for the treatment of clinical stage IIIB/C melanoma. Future Oncol. 2019 Nov;15(32):3665-3674. doi: 10.2217/fon-2019-0433. Epub 2019 Sep 20.
Results Reference
derived

Learn more about this trial

Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C Melanoma Patients

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