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Recruiting Phase 1

Neoadjuvant Immunotherapy for Patients With High-risk Eye Melanoma

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About this study

The goal of this clinical trial is to investigate the safety and feasibility of neoadjuvant immunotherapy for patients with high-risk uveal melanoma. The main question is: \- Is neoadjuvant treatment with nivolumab and ipilimumab safe and feasible for patientt with high-riks uveal melanoma? In addition pathological response, distant metastases-free survival, overall survival and immunological changes in the tumor microenviroenment after therapy will be assesed.

Condition
Uveal Melanoma
Tested
Nivolumab & Ipilimumab
Sponsor
Inge Marie Svane

Who can join

Age
18 to 80 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 21

  • Minimum age: 18 years
  • Maximum age: 80 years
  • Study condition: Uveal Melanoma
  • Age ≥ 18 ≤ 80
  • The patient is able to read and understand Danish.
  • Primary, localized and treatment-naive uveal melanoma planned for enucleation (high risk/T3-T4) and available for transvitreal biopsies. The initial diagnosis of uveal melanoma is based on ophthalmologic and clinical findings.
  • ECOG performance status of 0 or 1 (appendix 2)
  • The patient meets the following haematological and biochemical criteria at time of screening: a) AST and ALT ≤2,5 X ULN, b) Serum total bilirubin ≤1,5 X ULN or direct bilirubin ≤ ULN for patient with total bilirubin level \> 1,5 ULN, c) Serum creatinine ≤1,5 X ULN, d) ANC (Absolute Neutrophil Count) ≥1,000/mcL, e) Platelets ≥ 75,000 /mcL, f) Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L
  • Signed statement of consent after receiving oral and written study information
  • Willingness to participate in the planned treatment and follow-up schedule
  • For women of childbearing potential (WOCBP) a negative serum pregnancy test at time of screening and the use of highly effective contraception is required. This applies from screening and until 6 months after treatment.
  • The following is considered highly effective methods of contraception: 1.
  • Combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal or transdermal), 2.
  • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) 3.
  • Intrauterine device (IUD) 4. intrauterine hormone-releasing system (IUS) 5.
  • Bilateral tubal occlusion, 6.
  • Vasectomised partner provided that the vasectomy is confirmed successful, 7.
  • Sexual abstinence defined as refraining from heterosexual intercourse.
  • WOCBP must also agree to refrain from egg donation, storage, or banking during these same time periods.
  • \- Men with female partner of childbearing potential must: 1. Use a condom during sexual intercourse from screening and until 6 months after treatment. 2.
  • Ensure that their partner uses a highly effective method of contraception (as described above) 3. Agree to refrain from sperm donation, storage, or banking

Exclusion 13

  • A history of prior malignancies.
  • Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 2 years after treatment.
  • Subjects with curatively treated ductal carcinoma in situ (DCIS or LCIS) breast cancer for which they are taking hormonal therapy is acceptable.
  • Resectable squamous or basal cell carcinoma of the skin is acceptable.
  • Requirement for immunosuppressive doses of systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive drugs within the last 3 weeks prior to screening
  • The patient has any condition that will interfere with patient compliance or safety (including but not limited to psychiatric or substance abuse disorders)
  • The patient is pregnant or breastfeeding
  • The patient has an active infection requiring systemic therapy
  • Significant medical disorder according to investigator; e.g severe asthma or chronic obstructive lung disease, dysregulated heart disease or dysregulated diabetes mellitus.
  • Concurrent treatment with other experimental drugs
  • Any significant active autoimmune disease
  • Severe allergy or anaphylactic reactions earlier in life
  • Known hypersensitivity to one of the active drugs or one or more of the excipients.

Where

1 site, 1 recruiting

National Center for Cancer Immune Therapy, Department of Oncology, Herlev Hospital

Herlev, Herlev, Denmark

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.