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Trial record 1 of 1 for:    uv1-202
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UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma

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ClinicalTrials.gov Identifier: NCT04382664
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Ultimovacs ASA

Brief Summary:
UV1 is a therapeutic cancer vaccine that has been explored in prostate, lung cancer, in combination with ipilimumab in malignant melanoma and in combination with pembrolizumab in metastatic melanoma. This study will explore the Efficacy and Safety of UV1 administered with GM-CSF in combination with nivolumab and ipilimumab.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Biological: UV1 Biological: Sargramostim Biological: Ipilimumab Biological: Nivolumab Phase 2

Detailed Description:

This is a randomized, open label study to investigate efficacy and safety of UV1 vaccination in combination with nivolumab and ipilimumab as first line treatment of adult patients with histologically confirmed unresectable metastatic melanoma.

Patients in the experimental arm will receive 8 UV1 vaccinations over 4 cycles of nivolumab and ipilimumab. Patients in the control arm will receive 4 cycles of nivolumab and ipilimumab. Patients in both arms will start maintenance therapy 6 weeks after the last dose of induction therapy, nivolumab at a dose of 480 mg every 4 weeks.

All patients will be followed up until death or until the end of the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of UV1 Vaccination in Combination With Nivolumab and Ipilimumab as First Line Treatment of Patients With Unresectable or Metastatic Melanoma (INITIUM Study)
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : August 15, 2022
Estimated Study Completion Date : September 12, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: UV1 vaccination + nivolumab and ipilimumab
UV1 vaccination + nivolumab and ipilimumab
Biological: UV1
UV1 vaccine (300 μg) will be injected intradermally.

Biological: Sargramostim
Sargramostim (75 μg) is used as a vaccine adjuvant.
Other Name: Leukine

Biological: Ipilimumab
Ipilimumab is dosed according to label.
Other Name: Yervoy

Biological: Nivolumab
Nivolumab is dosed according to label.
Other Name: Opdivo

Active Comparator: Nivolumab and ipilimumab
nivolumab and ipilimumab
Biological: Ipilimumab
Ipilimumab is dosed according to label.
Other Name: Yervoy

Biological: Nivolumab
Nivolumab is dosed according to label.
Other Name: Opdivo




Primary Outcome Measures :
  1. PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Time from randomization to progressive disease (PD) or death from any cause, estimated up to 27 months ]
    Compare progression free survival (PFS) of UV1 vaccination in combination with nivolumab and ipilimumab to that of nivolumab and ipilimumab


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Time from randomization to death from any cause /follow-up until 70 PFS, estimated up to 27 months ]
    Compare Overall Survival of UV1 vaccination in combination with nivolumab and ipilimumab to that of nivolumab and ipilimumab .

  2. ORR per RECIST 1.1 [ Time Frame: Time from first ORR or death from any cause, estimated up to 27 months. ]
    Compare the objective response rate (ORR) of UV1 vaccination in combination with nivolumab and ipilimumab to that of nivolumab and ipilimumab.

  3. DOR per RECIST 1.1 [ Time Frame: Time from first CR or PR to PD or death from any cause, estimated up to 27 months. ]
    Compare duration of response (DOR) of UV1 vaccination in combination with nivolumab and ipilimumab to that of nivolumab and ipilimumab.

  4. Evaluation of Adverse events, vital signs, laboratory assessments and ECOG performance status [ Time Frame: Time from randomization to end of study, estimated up to 27 months ]
    Compare the safety of UV1 vaccination in combination with nivolumab and ipilimumab to that of nivolumab and ipilimumab. Safety will be listed and summarized descriptively by treatment arm comparing number of participants with observation and changes from baseline and at each visit related to AEs, deaths, vital signs (weight (kg), systolic and diastolic blood pressure (mmHg), pulse rate (bpm), body temperature (°C)), laboratory assessments and ECOG performance status (Grade 0 - Grade 5).


Other Outcome Measures:
  1. Immunological mechanisms [ Time Frame: Time from randomization to end of study, estimated up to 27 months ]
    To elucidate the immunological mechanisms underlying the interplay between immune activation provoked by UV1 vaccination and inhibition of tumor resistance mechanisms and peripheral immune tolerance induced by checkpoint blockade and how biological factors affect the efficacy of the combination therapy. This will be evaluated by change in immune- and tumor-related gene, cell, and protein profiles in blood over time in both treatment arms (analysis of plasma proteins, cell-free plasma DNA, and cellular genomic DNA).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients at least 18 years of age at the time of signing the ICF.
  2. Histologically confirmed diagnosis of unresectable stage IIIB D, or unresectable stage IV malignant melanoma.
  3. Eligible for combination treatment with nivolumab and ipilimumab.
  4. An ECOG performance status of 0 or 1.
  5. Adequate organ function as indicated by the following laboratory values:

    Hematological

    1. Absolute neutrophil count ≥1,500/µL
    2. Platelet count ≥100 x 103/µL
    3. Hemoglobin ≥9 g/dL or ≥5.6 mmol/L Renal
    4. Serum creatinine ≤1.5 x upper limit of normal (ULN) Hepatic
    5. Serum total bilirubin ≤1.5 x ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 ULN
    6. Aspartate aminotransferase/serum glutamic oxaloacetic transaminase and alanine aminotransferase/serum glutamic pyruvic transaminase ≤2.5 x ULN for patients without liver metastasis or ≤5 x ULN for patients with liver metastasis.
  6. Male patients who are sexually active with a female of childbearing potential must agree to use an adequate method of contraception.
  7. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test.
  8. WOCBP must use adequate contraception.

Exclusion Criteria:

  1. Previous non melanoma malignancies unless curatively treated and complete remission was achieved at least 2 years prior to randomization. Patients with prior curatively treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast, or other in situ cancers are allowed irrespective of time passed since curative treatment. Patients with prior completely resected malignant melanoma are also allowed.
  2. Known brain metastases or leptomeningeal metastases. If a patient experiences neurological symptoms indicative of brain metastases, a brain MRI should be performed.
  3. Diagnosis of uveal or ocular melanoma.
  4. Known history or any evidence of active, non-infectious pneumonitis.
  5. History of New York Heart Association class 3-4 congestive heart failure or history of myocardial infarction within 6 months of starting induction therapy.
  6. Active infection requiring systemic treatment.
  7. Diagnosis of immunodeficiency.
  8. Known history of severe hypersensitivity reactions to nivolumab, ipilimumab, sargramostim, or their excipients.
  9. Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
  10. History of or active hepatitis B (hepatitis B surface antigen reactive) or active hepatitis C (hepatitis C virus antibody).
  11. Women who are breastfeeding.
  12. Prior systemic treatment for unresectable stage IIIB D or unresectable stage IV malignant melanoma.
  13. Systemic corticosteroid treatment (doses exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive treatment within 7 days prior to the first dose of induction therapy.
  14. Receipt of a live vaccine within 30 days prior to start of induction therapy.
  15. Receipt of any other investigational treatment within 4 weeks of the first dose of induction therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04382664


Contacts
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Contact: Øivind Foss 0047 970 08 357 oivind.foss@ultimovacs.com

Locations
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United States, Arkansas
Highlands Oncology Group Recruiting
Fayetteville, Arkansas, United States, 72703
United States, California
California Cancer Associates for Research & Excellence (CCARE Not yet recruiting
San Marcos, California, United States, 92083
Saint John's Health Center - John Wayne Cancer Institute (JWCI) Recruiting
Santa Monica, California, United States, 90404
United States, Florida
Ocala Oncology Center Not yet recruiting
Ocala, Florida, United States, 34474
United States, Kentucky
Norton Cancer Institute Not yet recruiting
Louisville, Kentucky, United States, 40241
United States, Nebraska
Nebraska Cancer Specialists- Midwest Cancer Center Not yet recruiting
Papillion, Nebraska, United States, 68046-5706
United States, Oklahoma
Saint Francis Cancer Center Not yet recruiting
Tulsa, Oklahoma, United States, 74146
Belgium
Antwerp University Hospital Not yet recruiting
Antwerp, Belgium, 2650
Cliniques Universitaires Saint-Luc Not yet recruiting
Brussel, Belgium, 1200
Leuven University Hospital Not yet recruiting
Leuven, Belgium, 3000
GZA Hospital Sint-Augustinus Not yet recruiting
Wilrijk, Belgium, 2610
Norway
Sørlandet Sykehus HF(SSHF) Not yet recruiting
Kristiansand, Norway, 4615
Oslo University Hospital - The Norwegian Radium Hospital Recruiting
Oslo, Norway, 4953
Stavanger University Hospital Recruiting
Stavanger, Norway, 4068
Ålesund Hospital- Helse Sunnmore HF Not yet recruiting
Ålesund, Norway, 6026
Sponsors and Collaborators
Ultimovacs ASA
Investigators
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Principal Investigator: Steven J O'Day Saint John's Health Center - John Wayne Cancer Institute (JWCI)
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Responsible Party: Ultimovacs ASA
ClinicalTrials.gov Identifier: NCT04382664    
Other Study ID Numbers: UV1-202
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Ipilimumab
Sargramostim
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs