RECRUITING

Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma

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Conditions

Melanoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to study the impact of Neoadjuvant ipilimumab and nivolumab for melanoma patients that had recurrence during or after adjuvant anti-PD-1 therapy. Participants will receive 2 cycles of treatment prior to their standard of care surgery. After surgery participants will receive standard of care adjuvant therapy and be followed for response.

Official Title

Phase II Study of Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma

Quick Facts

Study Start:2024-11
Study Completion:2029-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06365619

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects aged ≥ 18 years.
  2. * Histologically confirmed Stage IIIB-D or Stage IV recurrent metastatic melanoma that is resectable or borderline resectable as determined by a Surgical Oncologist.
  3. * Recurrent disease at eligibility must have been confirmed with biopsy while receiving or within 3 months of completion of adjuvant anti-PD1 therapy.
  4. * ECOG Performance Status ≤ 1.
  5. * Adequate organ function as defined as:
  6. * Hematologic:
  7. * Absolute neutrophil count (ANC) ≥ 1500/mm3
  8. * Platelet count ≥ 100,000/mm3
  9. * Hemoglobin ≥ 10 g/dL
  10. * Hepatic:
  11. * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
  12. * AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN ----Subjects with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.
  13. * Renal:
  14. * Estimated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula:
  15. * For subjects of childbearing potential: Negative pregnancy test or evidence of post-menopausal status or evidence of permanent surgical sterilization. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  16. * Subjects \< 50 years of age:
  17. * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
  18. * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
  19. * Subjects ≥ 50 years of age:
  20. * Amenorrheic for ≥ 12 months following cessation of all exogenous hormonal treatments; or
  21. * Had radiation-induced menopause with last menses \>1 year ago; or
  22. * Had chemotherapy-induced menopause with last menses \>1 year ago
  23. * Subjects of childbearing potential and subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.3.1.
  24. * Subject has adequate archival tissue or agrees to undergo a fresh tissue biopsy if sufficient archival tissue is unavailable.
  25. * Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy per the treating investigator.
  26. * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
  1. * Receiving other investigational agents currently or within 28 days of study treatment.
  2. * Prior systemic anti-cancer therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.
  3. * Prior radiotherapy 45 days prior to the first dose of study treatment.
  4. * Major surgery 4 weeks prior to starting study drug or who have not fully recovered from major surgery.
  5. * Active infection requiring the use of systemic antibiotics.
  6. * Systemic steroid therapy greater than physiologic equivalent (10mg prednisone/day) or any other form of systemic immunosuppressive therapy within 7 days prior to registration.
  7. * Active secondary malignancy, unless the malignancy is not expected to interfere with the evaluation of safety
  8. * Known brain metastases or cranial epidural disease.
  9. * Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
  10. * Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.
  11. * Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.
  12. * QTc prolongation defined as a QTcF \> 500 ms.
  13. * Known congenital long QT.
  14. * Left ventricular ejection fraction \< 55%.
  15. * Uncontrolled hypertension defined as ≥ 140/90 as assessed from the mean of three consecutive blood pressure measurements taken over 10 minutes.
  16. * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, \[subjects may not receive the drug through a feeding tube\], social/psychological issues, etc.)
  17. * HIV infection with a detectable viral load within 6 months of the anticipated start of treatment.
  18. * Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (positive HBV surface antigen (HBsAg) result), or hepatitis C.
  19. * Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.
  20. * Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).
  21. * Subjects taking prohibited medications as described in Section 6.7.2. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.

Contacts and Locations

Study Contact

Kaitlin Stephens
CONTACT
801-213-8494
kaitlin.stephens@hci.utah.edu

Principal Investigator

Siwen Hu-Lieskovan, PhD, MD
PRINCIPAL_INVESTIGATOR
Huntsman Cancer Institute

Study Locations (Sites)

Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: University of Utah

  • Siwen Hu-Lieskovan, PhD, MD, PRINCIPAL_INVESTIGATOR, Huntsman Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11
Study Completion Date2029-08

Study Record Updates

Study Start Date2024-11
Study Completion Date2029-08

Terms related to this study

Additional Relevant MeSH Terms

  • Melanoma