Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma

  • Interventional
  • Recruiting
  • NCT03070392
Eligibility Details Visit Clinicaltrials.gov

A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared With Investigator Choice in HLA-A*0201 Positive Patients With Previously Untreated Advanced Uveal Melanoma

To evaluate the overall survival of HLA-A*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.

This Phase II study is designed to evaluate the safety and efficacy of IMCgp100 compared with Investigator's Choice (dacarbazine, ipilimumab or pembrolizumab) in HLA-A*0201 positive adult patients with advanced UM treated in the first line setting with no prior systemic or liver-directed chemo-, radio- or immune-therapy administered in the advanced setting (prior surgical resection of liver metastases and adjuvant systemic therapy are acceptable). Comparison of the IMCgp100 efficacy results in this Phase II study will be made with the concurrently randomized arm (Investigator's Choice) with a primary endpoint of overall survival (OS) and secondary efficacy endpoints of progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), and disease control rate (DCR).

Gender
All

Age Group
18 Years to 99 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         1. Male or female patients age ≥ 18 years of age at the time of informed consent

         2. Ability to provide and understand written informed consent prior to any study procedures

         3. Histologically or cytologically confirmed metastatic UM

         4. No prior systemic therapy in the metastatic or advanced setting

         5. No prior local, liver-directed therapy; prior surgical resection of oligometastatic liver disease is allowed

         6. Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in patients with localized disease

        Exclusion Criteria:

         1. Impaired baseline organ function as evaluated by out-of-range laboratory values

         2. History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies

         3. Clinically significant cardiac disease or impaired cardiac function

         4. Presence of symptomatic or untreated central nervous system (CNS) metastases

         5. Active infection requiring systemic antibiotic therapy

         6. Known history of human immunodeficiency virus infection (HIV)

         7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

         8. Malignant disease, other than that being treated in this study

         9. Patients receiving systemic steroid therapy or any other systemic immunosuppressive medication. Local steroid therapies are acceptable

         10. History of adrenal insufficiency, pneumonitis, interstitial lung disease, or inflammatory bowel disease

         11. Major surgery within 2 weeks of the first dose of study drug

         12. Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative radiotherapy to a limited field

         13. Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GM-CSF, M-CSF) ≤ 2 weeks prior to start of study drug

         14. Pregnant, likely to become pregnant, or lactating women
  • Uveal Melanoma
  • Cancer

At a Glance

National Government IDNCT03070392

IRB#IRB17-0232

Lead SponsorImmunocore Ltd

Lead PhysicianThomas F. Gajewski

Collaborator(s)N/A

EligibilityAll
18 Years to 99 Years
Recruiting